Spinal News International Issue 48

Sept

Issue

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Sept

18 48

Surgeons call for ban on pedicle screw reuse

Todd Albert:

Physician burnout Page 12

Frank Kandziora:

Contaminated pedicle screws cost hundreds of thousands of US dollars a year, and through an increase in surgical site infections result in additional and avoidable patient morbidity. Anand Agarwal (University of Toledo, Toledo, USA) and colleagues are calling for a change in the standard of care revolving around implant handling and delivery, cutting costs and improving patient safety.

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pecifically, reprocessed pedicle screws have been shown to still have residual microbial and non-microbial contaminants on them. In a study conducted by Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) and colleagues, published in the Global Spine Journal, traces of saccharides (including biofilm, endotoxins and fatty tissue), soap residue, and salt residue were identified on six pedicle screws randomly selected from four different trays of cleaned, wrapped and purportedly sterilised implants. In fact, there is evidence that the amount of carbohydrate residue increases following reprocessing. The investigators also found corrosion stains present on the outer surface of the implants.

The screws were retrieved using clean gloves, and immediately placed inside of clean zip-lock polybags before undergoing optical microscopy, scanning electron microscopy with energy dispersive spectroscopy, and Fourier transform infrared spectroscopy.

That reprocessed pedicle screws are not always fully sterile has already influenced policy decisions in some nations. Japan and Scotland have banned the reprocessing of spinal implants used for spinal surgery. The Scottish Health Department said in a statement that repeatedly reprocessing implants in the hospital “is a suboptimal procedure”, following a letter in 2006 from the then chief medical officer for Scotland, Harry Burns.

Burns wrote: “Most orthopaedic units in NHS Scotland use screws, small plates and other small orthopaedic implants which have been repeatedly reprocessed (cleaned and sterilised) by the local Central Decontamination Unit in racks or trays. Concerns have been raised that these implants cannot be properly cleaned, and we have photomicroscopic evidence that they retain or acquire organic and/or chemical residues during reprocessing. Legally, many of these devices are classified as ‘single use’, which means they must not be re-used following contact with a patient, but also that they should only be cleaned and sterilised once, prior to first use. We suspect many of these devices have been recirculating for many years, some perhaps for over two decades. Besides generic concerns over infection

Bacterial growth found on a reprocessed screw (left) vs. a pre-sterile prepackaged pedicle screw (right)

and CJD [Creutzfeldt-Jakob Disease] contamination, there is evidence to suggest that reprocessed steel implants can cause inflammatory reactions to a much greater degree than ‘pristine’ devices as delivered by the manufacturer, and there are also issues of corrosion and weakening caused by repeated processing. This has clear implications for reducing implant failures, and we have no option but to address the legal, regulatory and governance issues this practice raises.”

Recent research from Aakash Agarwal and colleagues concurs with Burns, citing multiple issues with conventional reprocessing. Foremost among these is the increased rate of surgical infection. The incidence of surgical site infections in spine surgery is reported in the medical literature as up to 13%. Writing in a separate study also published in the Global Spine Journal, Aakash Agarwal et al write: “Surgical infection is undoubtedly a multifactorial phenomenon with implant handling and clean delivery being only one of these factors [influencing infection rates].” An increased infection rate necessitates longer hospital stays, and may mean that patients are required to undergo reoperations. In addition to the financial and logistical issues this causes, spending a longer time in hospital places an emotional burden on patients. The financial burden of surgical site infections is huge. According to the literature, the average hospitalisation cost for a surgical site infection resulting from orthopaedic surgery is estimated to be US$62,000 per case, at an average frequency of 5.5% of cases.

Continued on page 2

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Amount of curve correction matters for achieving balanced shoulders in scoliosis patients

In Lenke type 1 or type 2 adolescent idiopathic scoliosis (AIS), significant correction of the main thoracic curve with relative under-correction of the proximal thoracic curve increases the incidence of postoperative shoulder height imbalance.

This is the conclusion presented by Alex Sielatycki (Department of Orthopaedic Surgery, Columbia University, New York, USA) at the 25th International Meeting on Advanced Spine Techniques (IMAST; 11–14 July, Los Angeles, USA).

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f the importance of these findings, Sielatycki comments: “Postoperative shoulder height imbalance is a relatively common phenomenon after surgical correction of Lenke type 1 or 2 AIS, and when it occurs it can be particularly bothersome for patients and their families.

We believe our findings are important in that they highlight the need to carefully assess the correction of both the main thoracic and proximal thoracic curves relative to

each other. Our hope is that surgeons will use this information to guide their decision making and reduce the risk for shoulder imbalance.”

The study from Columbia University and the Harms Study Group sought to analyse how much the amount of curve correction of both main curves and proximal curves contributes to shoulder balance in patients with Lenke Type 1 and Type 2 AIS. Thirteen surgeons Continued on page 2

2

Sept

Surgeons call for ban on pedicle screw reuse

Amount of curve correction matters for achieving balanced shoulders in scoliosis patients Continued from page 1

reviewed preoperative and five year postoperative Xrays and clinical radiographs from a large, multicentre database (the Harms Study Group) of 145 Lenke type 1 or type 2 AIS patients who were corrected with pedicle screw/ rod constructs. All patients had at least five years’ follow-up.

Using multivariate analysis to identify predictors of postoperative shoulder imbalance, the investigators report that shoulder imbalance was most common when the proximal curve was corrected less than 52%, and the main curve was corrected more than 53%. For these patients, only 41.3% had balanced shoulders, meaning almost 60% of this cohort had asymmetrical shoulders.

Postoperative shoulder height imbalance is a significant potential complication in scoliosis patients, Sielatycki informed the IMAST audience, and is reported in approximately 25–40% cases in the literature.

According to Sielatycki, while it is thought that a more cephalad upper instrumented vertebra is thought to mitigate this shoulder imbalance postoperatively, there is little attention paid to how much the amount of curve correction contributes to shoulder balance, and this is what attracted him and his colleagues to the research.

Sielatycki explains, “Shoulder height imbalance is a relatively common problem following these operations, and there is relatively little attention given to the proper surgical techniques to reduce this complication.”

“As our manuscript mentions, many studies discuss choosing a more proximal upper instrumented vertebra (UIV) as a means to mitigate this risk, however our clinical experience has been that merely instrumenting a more cranial UIV does not itself reduce the risk for imbalanced shoulders. The indirect connection is that a more proximal UIV will allow the surgeon to control the proximal curve, however the real work comes with using corrective manoeuvres (distraction across the concavity and compression across the convexity) to level the UIV and balance the shoulders.”

Speaking to Spinal News International about the clinical ramifications of his research, Sielatycki comments, “Achieving maximal thoracic curve correction and good shoulder height balance are two goals in AIS surgery that are somewhat at odds. Our study shows that when the main curve is maximally corrected, the risk for shoulder height imbalance is increased; particularly when the proximal curve is not adequately corrected.

We are hopeful that findings of our study will provide

Continued from page 1

Avoiding contamination

Speaking to Spinal News International, Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA), first author on four studies published this year investigating the impact of contamination of reprocessed pedicle screws, explains, “In the first phase, i.e. preoperative contamination, the pedicles screws undergo repeated bulk-cleaning with dirty instruments from the operating room, leading to residue build up at the interfaces and possibly on the surfaces too. This, due to its concealed nature, remains unnoticed by the Sterile Processing Department or other hospital staff.”

However, Aakash Agarwal goes on to note, “These can be avoided by using single-use pre-sterilised screws, which are becoming popular these days, with many countries issuing a ban towards repeated implant reprocessing.”

The second source of contamination is intraoperatively. This may occur, according to Agarwal, if “the sterile pedicle screw shafts are directly touched by the scrub technician with soiled gloves for loading onto an insertion device/screw driver, and is then kept exposed on the working table (either separately or next to the used instruments as the pedicles hole are being prepared).”

In order to avoid this contamination, Aakash Agarwal and colleagues recommend shielding the pedicle screws intraoperatively using a guard. Plastic surgeons and general surgeons have adopted a practice of using an additional layer of barrier against contamination of the implants (Keller’s funnel and wound edge protectors, respectively), and the study investigators suggest it is time for spinal surgeons to follow suit.

Aakash Agarwal comments, “Shielding the pedicle screws intraoperatively using a guard provides a superior level of asepsis than currently practiced. All unshielded pedicle screws were carrying bioburden of virulent bacterial species, which provides an opportunity for the development of postoperative infections.” It should be noted that Aakash Agarwal is director of research and development for Spinal Balance, a company providing sterile and proprietary no-touch orthopaedic implants; Anand Agarwal holds a stock option in Spinal Balance.

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Alex Sielatycki presenting at IMAST

useful information for scoliosis surgeons in achieving the goals of maximal curve correction as well good shoulder height balance.”

From Sielatycki et al’s research, the influence of degree of curve correction proved to be great in determining shoulder imbalance. In contrast, Sielatycki explained that, “A more proximal UIV did not show any difference in average correction of that proximal curve, and also the UIV did not influence which correction category each patient fell into.”

Five years on from surgery, 93 (64%) of the 145 patients analysed in the study had balanced shoulders. Where the proximal curve had been corrected more than 52%, this rose to 79.7% with balanced shoulders, meaning only 20% were unbalanced (the flip-side of this being that for patients with a proximal curve correction of less than 52%, almost half—46%—had unbalanced shoulders).

Large corrections of the main thoracic curve (greater than 53%), coupled with a relatively small proximal curve correction (less than 52%) led to more than half of patients having unbalanced shoulders (59.7% asymmetrical; 41.3% balanced). However, under-correcting both the proximal and main curve—by less than 52% and 53% respectively—resulted in patients with balanced shoulder 87% of the time.

Sielatycki concluded his talk with the advice: “You really need to pay careful attention to the correction of that proximal curve relative to the amount of correction of the main thoracic curve, whether it is instrumented or not, and if you are instrumenting that proximal curve, you should take care to distract across the proximal concavity, and compress across the convexity to level the UIV, and achieve good postoperative shoulder height balance.”

For this research, Sielatycki and colleagues were awarded the Whitecloud Award for the Best Clinical Paper presented at IMAST 2018.

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2018

4

Sept

Second scoliosis surgery of the day as safe and effective as first

Scoliosis correction is an extensive surgery, and operating on multiple patients in one day can be exhausting for the surgical team. However, recent research finds that the second surgery of the day has similar outcomes and complication rates compared to the first surgery. Additionally, the second surgery had similar results to single day scoliosis surgeries.

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his is the conclusion reached by Vishal Sarwahi and colleagues (New York, USA), presented by Sarwahi at the 25th International Meeting on Advanced Spine Techniques (IMAST; 11–14 July, Los Angeles, USA). The investigators conducted an ambispective review of 251 scoliosis surgeries between 2011–2017.

Sarwahi told the IMAST audience, “During the summer months, surgeons often book multiple adolescent idiopathic scoliosis surgeries on the same day. However, a later operative start time and lack of a consistent surgical team, especially for the second case, has been shown to increase surgical complications and adverse patient outcomes.” Additionally, other specialties have reported differences in outcome between the first and second surgery of the day: cardiac cases after 3pm have been shown to increase mortality risk by two, and liver transplants starting after 3pm were not only longer, but had twice the mortality risk of a morning operation.

Therefore, the study investigators set out to determine if they could detect a difference in the number of complication rates between the first and second surgery of the day for scoliosis corrections.

They found that multiple scoliosis surgeries in one day can be performed safely without compromising radiographic or perioperative outcomes. When comparing the first scoliosis surgeries of the day with the second, the investigators found that surgical time, estimated blood loss, and postoperative Cobb angle were all similar.

The first surgery of the day typically

Vishal Sarwahi presenting his talk at the 25th IMAST, Los Angeles, USA

lasted for 224 minutes, compared to 214 minutes for the second surgery. Estimated blood loss was 400ml for the first surgery of the day, compared to an average of 350ml in the day’s second surgery. Where the preoperative Cobb angle for patients undergoing the first or second surgery of the day was similar (51.5 vs. 46.7, respectively), the postoperative Cobb angle was also alike for both groups: 17.9 vs. 16.3 (p=0.428).

When comparing the second surgery of the day to operations where the case was the only scoliosis surgery of the day, the operative time was significantly shorter for the second surgery, at 214 minutes compared with 267 minutes (p=0.001).

However, similar complication rates were observed: 4.3% for the day’s second

surgery, and 8.3% for the only surgery of the day (p=1.0).

Another factor the investigators took into consideration was whether or not the same surgeons were performing the two operations in the day, or if it made a difference to the surgical outcome if the operating team was new in the afternoon.

Lack of a consistent team has previously been shown to be linked with an increase in complications for some surgeries. However, when Sarwahi and colleagues investigated this factor for scoliosis surgeries, they found that changes in the operating team for the second case does not appear to impact safety, efficiency or outcomes.

Sarwahi and colleagues split the 251 scoliosis surgeries they were analysing into four groups. These were as follows:

Recent findings contradict the common recommendation to rapidly lose weight prior to lumbar fusion surgery According to Woojin Cho (Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine, New York, USA), who presented at the 25th International Meeting on Advanced Spine Techniques (IMAST; July 11–14, Los Angeles, USA), spinal surgeons continue to wrongly recommend bariatric surgery to obese patients prior to lumbar fusion surgery to reduce the risk of developing post-operative complications. The research presented by Cho contradicts this recommendation, with rapid body weight reduction prior to lumbar fusion surgery associated with poorer post-operative outcomes.

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Scoliosis

he authors aimed to compare the rates of the development of post-operative complications in patients who either did or did not undergo previous bariatric surgery and massive weight loss prior to lumbar fusion surgery for lower back pain.

Patients who underwent lumbar fusion surgery present on the National Surgical Quality Improvement Program (NSQIP) dataset spanning 2005–2015 were included in the study. Patients were identified and stratified into groups based on significant weight loss, defined as: 10% weight loss within the six months prior to lumbar fusion surgery. Exclusion criteria included a history of malignancy or chronic disease.

Of the 39,742 patients who underwent the procedure, 129 (3.2%) met the criteria for significant weight loss, and were subsequently matched with a randomised non-weight loss patient based on age, sex, smoking status and BMI, to act as a control.

The two groups were compared in terms of surgical outcomes, including length of hospital stay, surgical site infections and deep vein thrombosis.

Interestingly, compared with the non-weight loss group, the weight loss group had significantly longer length of stay (9.7 vs. four days for the weight loss group, p<0.05), whilst the weight loss group experienced significantly more surgical site infections (eight

Group one: patients were the first scoliosis surgery of the day Group two: the second scoliosis surgery of the day Group three: the only scoliosis surgery of the day Group four: surgeries performed by surgeons who perform only one scoliosis surgery of the day In order to measure the impact of a consistent team, the study investigators compared the surgical outcomes and complication rates between patients in groups two and four: the patient cohort who were the second surgery of the day for the operating surgeon vs. those patients treated by a surgeon performing their first case. Group four were lacking a consistent surgical team. Group two had a significantly shorter surgical time; 214 minutes compared with 307 minutes in group four. Estimated blood loss and complication rates were also lower in group two—350ml vs. 600ml (p=0.02), and 4.3% vs. 11.8% (p=0.473).

Sarwahi and colleagues also compared adolescent idiopathic scoliosis cases in groups three and four; early and late start cases. At IMAST, Sarwahi explained, “This is the most interesting finding: there were no significant differences between the two groups.

The Cobb angle, kyphosis, postoperative Cobb correction, blood loss, levels fused… all were similar. The anaesthesia times were almost identical, as was the length of stay and the perioperative complications. So, interestingly, despite the late start, and despite the lack of variegated surgical time, there was no significant differences in the outcomes.”

Concluding, Sarwahi summarises, “The start time of standard posterior spinal fusion does not appear to impact patient outcomes, safety or length of stay. Lack of a consistent surgical team and anaestheologist also does not increase length of surgery, blood loss or complications. In addition, surgeon fatigue was not witnessed, as the clinical outcomes and operative time for second surgery were similar to the first case.”

vs. three among the non-weight loss group, p<0.05).

Furthermore, the number of transfusion occurrences and deep vein thrombosis were also significantly higher in the weight-loss group compared to the nonweight loss group (40 and five vs. 20 and 0, p<0.05, respectively).

Cho concluded that the study indicates a statistically significant association between massive weight loss prior to lumbar fusion surgery (greater than 10% of total body weight) and the development of post-operative conditions. He goes on to suggest reasons for this finding, based on several studies that have followed patients who underwent post-bariatric body contouring plastic surgery procedures.

According to Cho, these studies indicate that postbariatric macro and micronutrient deficiencies (Protein, Vitamin A, D, B6, B12, Folate, Zinc and Iron) are present in patients, subsequently impacting on wound healing and immune function. He suggests that worse post-operative outcomes in weight loss patients may therefore be due to deficiencies in nutrients.

Future studies, he noted, may include nutritional supplementation prior to lumbar fusion surgery, and may take into consideration the timing of spinal surgery after bariatric surgery.

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Global Spine Congress

Many surgeons do not use patientreported outcome measures in spine care Almost one third of spine surgeons do not routinely use patient-reported outcome measures (PROMs).

This was the result presented by Asdrubal Falavigna (Department of Neurosurgery, Caxias do Sul University, Caxias do Sul, Brazil) at the Global Spine Congress (1–5 May, Singapore), for which he and his colleagues received the prize for Best Paper.

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he investigators set out to determine the worldwide use of PROMs, and to assess the current status of knowledge and barriers to the routine use of a registry on a global scale. An electronic questionnaire was created by the study authors to evaluate demographic features of participants, familiarity with PROMs instruments, perception regarding the usefulness of PROMs in spine care, and barriers to implementing PROMs and clinical registries in routine practice. An e-mail request to participate in the survey was sent to members of AOSpine with a cover letter explaining the study objectives, with a link to Survey Monkey.

A total of 1,632 AOSpine members from Latin America, Europe, the Asia Pacific, North America and the Middle East answered the PROMs questionnaire.

Falavigna and colleagues found that 31.9% of respondents did not routinely use any of the PROMs, and 28.3% of spine surgeons were not familiar with the generic health-related quality of life questionnaire.

Speaking to Spinal News International of these results, Falavigna discloses: “In general, the participants strongly agree, [by] greater than four points, that PROMs are useful to evaluate treatment outcomes, compare results between centres, and monitor the impact of the disease. The residence or fellowship programmes had a positive influence on the use of the PROs in each region.

“Different lifestyles, training, economic burden, and cultures influenced the use of PROMs. “The present study agrees with the literature because the most important barriers for the physicians were lack of time to apply the questionnaires (57%), lack of staff to assist in data collection (72%), and lack of structure in the service to carry out data collection (60%).”

The study also found that the routine use of questionnaires was more frequent in North America and Europe, and less common in Latin America and the Middle East (p<0.001). In fact, being a spine surgeon in Europe (adjusted OR 1.90, 95% CI 1.46–2.46, P<0.001) and North America (adjusted OR 1.61, 95% CI 1.10–2.38, P 1⁄4 0.015) was found to have a positive indication for using PROMs. When accounting for this geographic disparity, 39% of survey respondents claimed that the lack of an electronic database was an important barrier, and most of these physicians were from Latin America, the Middle East, or the Asia Pacific region.

Working at an academic centre was also an independent predictor for PROM use (adjusted OR 2.39, 95% CI 1.93–2.96, P<0.001).

Barriers to using patientreported outcome measures

Asdrubal Falavigna

PROMs have the potential to narrow the gap between the clinician’s and the patient’s view of clinical reality and help tailor treatment to meet the patient’s preferences.

The benefits of patientreported outcome measures

PROMs are the most widely accepted means of measuring outcomes following spine procedures, according to the study authors. Outcome assessments made using PRO instruments help spine surgeons to better manage their patients and monitor treatment progress.

Falavigna explains to Spinal News International: “In patients with spinal disorders, the main objective of treatment is to improve health-related quality of life by reducing pain and disability. In this sense, the best meas-

urement of treatment quality should be the patient’s opinion regarding the results using patient-reported outcome measures (PROMs). PROMs have the potential to narrow the gap between the clinician’s and the patient’s view of clinical reality and help tailor treatment plans to meet the patient’s preferences and needs. In recent decades, several generic and disease-specific patientreported outcome instruments have been developed and validated for the clinical and functional evaluation of spinal treatment outcomes. Patient-reported outcome instruments provide results as numerical scores, making it easier to detect the changes between the pre- and postoperative periods.”

Falavigna lists the benefits of PROMs as allowing physicians to: Assess outcomes from the patients’ perspective Select patients for whom surgery is appropriate Evaluate the burden of disease Monitor treatment outcomes Facilitate patient-physician communication Allow results of treatments to be compared between different centres Measure treatment quality for health economic analyses in spine care Promote feedback regarding their performance, benchmarking and quality improvement

“In order to actively involve the treating physician, it is necessary to recognise and overcome the barriers to the implementation of clinical registries,” the investigators write.

These barriers to the full implementation of clinical registries differ in different regions of the world.

In the Middle East, Latin America, and the Asia Pacific region, a lack of an electronic database is the most significant barrier to utilising PROMs. According to the study authors, the main barriers to the full implementation of PROMs in health care appear to be lack of knowledge regarding their importance, an absence of physician reimbursement for the extra work, minimal financial support for clinical research in this area, the costs of implementation, and the capacity to administer the instruments.

However, there are some strategies that could be implemented to make PROMs more widely used. Falavigna explains, “Some strategies based on education in research (symposium, books, webinars, e-learning, postgraduation program training) and technical support have been conducted to increase the number and improve the quality of comparative-effectiveness research in spine care.

“Besides the need for implementation of clinical registry studies to assess the effectiveness of spine care in these countries, these efforts were also motivated by the low rate of scientific publications among Latin American spine surgeons in the last decade.

Prospective patients for the clinical registry who are undergoing elective spine surgery for lumbar degenerative diseases are enrolled in a clinical registry by the Caxias do Sul University Spine Surgery Group. Preoperative and follow-up data (30 days, six months, and annually) are collected including demographics, PROMs, radiologic results, and costs. All data are collected and managed with a database specifically built for this registry.

“Another strategy to support the use of PROMs in routine clinical care is to integrate them into routine workflow, something that could happen if they were mandatory in a given institution.”

Alternatives to using PROMs include clinical evaluation by surgeons and radiological measurements of the spine alignment.

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Global Spine Congress

Children with severe spinal deformity at high risk of revision surgery Paediatric patients with severe spinal deformity are at a high risk of revision surgeries. Presenting his research at the Global Spine Congress (GSC; 2–5 May, Singapore), Munish Gupta (Department of Orthopedics, Washington University, St Louis, USA) reported a 12% instrument-related complication rate following surgical treatment for severe pediatric deformities. Gupta and colleagues were awarded the best e-poster award for their work.

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he prospective, observational, multicentre study followed a cohort of 176 paediatric patients across 11 centres for a minimum of two years’ post-surgery correcting a severe spinal deformity. A severe deformity is defined by the investigators as a spinal curve greater than 100 degrees, or as a deformity necessitating a vertebral column resection. Gupta described this patient cohort to Spinal News International as “some of the most challenging patients.”

Twenty-one (12%) children experienced complications resulting from the instrumentation, and 15 patients (9%) required revision surgeries due to instrumentation failure or pseudoarthritis.

Of these 15 patients, one underwent revision surgery twice. The average time for revision surgery was 18 months postoperatively. The researchers also found that a further six patients (3%) had complications, but did not undergo any revision surgeries.

This high rate of revision surgeries in

surgically treated paediatric patients with severe spinal deformities was expected, due to the complex nature of the necessary operative procedures.

Speaking to the GSC audience, Gupta explained how severe paediatric deformities can be challenging to treat, due to difficulties with instrumentation placement in small patients, stress on implants due to correction of severe deformities, and the destabilisation effect of three column osteotomies, a high-risk, deformitycorrecting surgery involving removal of the vertebra from around the spinal cord to essentially cut the bone in half, before bending the spine into the desired shape and securing with screws and rods.

Gupta explains that while removal of the vertebral body and posterior elements “gives some freedom to manipulate the deformity to more how the spine should be”, it is a highly complex surgery.

In addition to the possibility of revision surgeries being necessary, complications affected patient’s self-image

Munish Gupta

and satisfaction. There was a significant association between a complication arising after surgery, and a lower reported self-image at two years’ follow-up.

For patients who did not experience a complication during surgery rated their self-image as 4.17, compared with those who had had a complication only rating their self-image an average of 3.66 (0.51 difference between the two ratings, p=0.0003).

Lower patient satisfaction at twoyear follow-up was also associated with surgical complications. The mean value patients assigned to their satisfaction

7

two years after surgery was 4.17 with no complications, compared to 4.57 if they had experienced a complication—patients with complications rate their satisfaction as 0.38 points less than those without surgical complications (p=0.0195).

Pain, function and mental health were unaffected by whether or not a patient had experienced surgical complications: there were no significant differences in patient reported outcome measures for these factors between patients who had complications, and those who did not.

Speaking to Spinal News International, Gupta explains how these paediatric patients with complex spinal deformities “require close and continued followup after two years.” There are plans to continue this work, with Gupta and colleagues planning on monitoring these patients to ultimately acquire five-year follow up data. “We are going to see if patients continue to have problems up to five years post-operatively. They may not have experienced any surgical failure after two years, but we do not know if that means they will not experience failure later on. Or, the rate of failure and complications may be the same after five years as after two. We do not know yet, which is why we are studying it. I think the healing should be done by two years, but we do not know for sure.”

Funding for this research was provided

by Marcella Fox through the Fox Pediatric Spinal Deformity Study Group, of which Gupta and his study co-authors are members.

8

Sept

First external validation of eight prognostic scoring systems identifies survival predictors in metastatic epidural spinal cord compression patients Three factors were found to be predictive of survival in a surgical series of metastatic epidural spinal cord compression, including the type of primary tumor and a lower degree of physical disability on the SF-36 physical component score. These results were presented at the 2018 American Association of Neurological Surgeons Annual Scientific Meeting (28 April–2 May, New Orleans, USA) by Brian D Silber Award winner Anick Nater-Goulet (University of Toronto, Toronto, Canada), who is supervised by Professor Michael Fehlings at the University of Toronto.

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his study is the first full external validation of eight prognostic scoring systems or model conducted in accordance with TRIPOD (the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) guideline.

For this project, researchers aimed to: Identify preoperative predictors of survival in adults treated surgically for a single metastatic epidural spinal cord compression lesion Examine how these predictors relate to eight prognostic scoring systems or model Perform the first full external validation of these prognostic scoring systems or model in accordance to the TRIPOD (the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) guideline.

One hundred and forty-two surgical metastatic epidural spinal cord compression patients were enrolled in the prospective, multicentre, North American cohort study, which was sponsored

by AOSpine North America and led

by Fehlings (also of the University of Toronto). Patients were followed for at least 12 months or until death.

The investigators identified three independent preoperative clinical factors associated with longer overall survival

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Spinal cord compression

Anick Nater-Goulet (left) and Michael Fehlings

for patients who underwent spinal decompression with or without reconstruction or stabilisation for a single metastatic epidural spinal cord compression lesion. Firstly, presence of a breast, prostate, or thyroid primary tumor. Secondly, an absence of organ metastasis. Thirdly, a lower degree of physical disability as reflected by a higher score on the SF-36v2 physical component questionnaire.

The SF-36v2 questionnaire is a generic health survey that asks 36 questions to measure functional health and well-being from the patient’s perspective, and takes five to ten minutes to complete.

Detailing why this work was undertaken, Nater-Goulet tells Spinal News International: “A recent systematic review of the literature reported that the current body of evidence exploring prognostic factors of survival in treated surgically metastatic epidural spinal cord compression patients has a moderately high risk of bias due to shortfalls in the design, conduct, analysis, and reporting of studies. Consequently, the strength of the overall body of evidence for predictors of survival in this patient population is low.” Additionally, prospectively gathered clinical data are more complete and precise than those obtained retrospectively.

Nater-Goulet comments, “We performed the first full external validation of eight current prognostic scoring systems or model in accordance with the TRIPOD guidelines, which revealed that none of these prognostic scoring systems or model were able to accurately predict survival in our surgical cohort. In fact, discrimination was possibly helpful and calibration was overall poor. Therefore, clinicians should use these prognostic scoring systems or model with caution, especially if they are applied in a patient population different from the population in which the model was developed.”

Nater-Goulet and colleagues describes being awarded the Brian D Silber Award at AANS as “a terrific honour”, saying, “Having seen the number of exceptional abstracts presented during the session, we are convinced the decision must have been very difficult. It is thrilling to be recognised by our peers from such a well-established and outstanding association as the AANS and it is a fabulous source of motivation to pursue our goal to contribute to expanding scientific knowledge.”

Looking forward, Nater-Goulet tells Spinal News International, “There is a need to create and validate a clinical prognostic model of survival in patients with metastatic epidural spinal cord compression who undergo surgical treatment, to inform [patients] about prognosis, to assist both clinicians and patients in the process of joint clinical decisionmaking, and to help manage patient expectations. Although life expectancy is an important aspect to consider in patients with metastatic epidural spinal cord compression, quality-oflife is also cornerstone. Consequently, we should attempt to develop and validate clinical prognostic models of quality of life in this patient population.”

Bracing superior to exercise for treating spinal curvature in AIS patients, but exercise proven superior for mental health Both bracing and exercise have demonstrable, significant treatment effectiveness for patients with adolescent idiopathic scoliosis. This was the finding of a randomised, controlled trial presenting level one evidence, carried out by Yu Zheng (Interdisciplinary Division of Biomedical Engineering, The Hong Kong Polytechnic University, Hong Kong, China) and colleagues, recently published in Spine.

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he study aimed to investigate the effectiveness of orthotic management versus exercise on spinal curvature, body symmetry and quality

of life.

Bracing was found to be superior to capture corrections in parameters of spinal curvature (Cobb angle at the first 12 months of intervention, p=0.039), and body symmetry (though not significantly for this parameter). The quality of life scores were significantly better in the exercise group, especially function (p<0.001) and mental health (p<0.001) scores.

Twenty-four patients in the bracing group and 29 patients in the exercise group participated in this study. Patients were randomly assigned to either group. Those in the brac-

ing group were prescribed with a rigid throacolumbosacral orthosis, and requested to wear the brace for 23 hours a day. Patients in the exercise group, meanwhile, were treated with the Scientific Exercise Approach to Scoliosis (SEAS) protocol.

According to Romano et al, writing in Scoliosis and Spinal Disorders in 2015, SEAS is an individualised exercise programme adapted to all situations of conservative treatment of scoliosis, though in this study it functioned as a stand-alone treatment (as opposed to being a complimentary treatment to bracing). SEAS is based on a specific active self-correction technique performed without external aid, and incorporated in functional exercises. Improvement of the stability of the spine in active self-correction is the pri-

mary objective of SEAS. SEAS exercises train neuromotor function so to stimulate by reflex a self-corrected posture during the activities of daily life.

For the intragroup comparison, parameters of spinal curvature (baseline vs. 12-month, p<0.03 in the exercise group and p<0.001 in the bracing group), quality of life (baseline vs. 12-month, p<0.001), and TAPS (Trunk Appearance Perception Scale) (baseline vs. 12-month, p<0.033) significantly improved over the studied period. Shoulder balance (baseline vs. 12-month, p<0.005) showed significant improvement only in the bracing group.

Data regarding angle of trunk inclination, Cobb angle, shoulder balance, body image, and quality of life were collected every six months.

Writing in Spine, Zheng et al contextualise their research: “A number of well-designed studies comparing conservative treatment of adolescent idiopathic scoliosis (AIS) have been conducted, and the evidence becomes stronger.

However, there is a lack of information on the effectiveness of orthotic management versus exercise.”

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First immune-evasive gene therapy for spinal cord injury restores grasping function A novel immune-evasive gene therapy has restored skilled grasping function in paralysed rats, allowing treated rodents to independently reach for and pick up sugar cubes, research recently published in Brain reports. The findings of the preclinical study support the ongoing development of chondroitinase ABC (ChABC) gene therapy towards clinical application for the treatment of chronic spinal cord injury in humans.

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hABC—an enzyme that degrades glial scar tissue that forms around a spinal cord injury site—has previously been demonstrated to reverse neurite growth arrest in vivo, enhance central nervous system axonal regeneration and plasticity, and promote functional recovery following a spinal cord injury.

In this study, the investigators transduced host cells to express the ChABC gene, circumventing the need for repeated, invasive administration of the enzyme.

However, while gene therapy is a promising therapeutic strategy for the treatment of spinal cord injury, the scientific literature reports that uncontrolled gene expression can limit or even reverse any therapeutic benefits. As such, lead author Emily Burnside (King’s College London, UK) and colleagues used the broad-spectrum antibiotic doxycycline to regulate ChABC expression.

The administration of doxycycline “switches off” the gene responsible for ChABC production, whilst removal of doxycycline allows for ChABC gene expression.

The authors write, “The ability to both administer and remove any treatment has a key advantage over permanent application in

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Gene therapy

the development of clinically feasible strategies.” The ability to turn off the treatment is consequently a step in the right direction towards eventual human treatment.

A further obstacle to effective treatment with gene therapy is the mammalian adaptive immune response. In previous studies involving doxycyclineinduced transgene vectors, when the system has been used in non-human primates, an immune response has been activated and T-cells remove those cells expressing the transgene.

To avoid the issue of immune recognition and removal, the investigators utilised an immune-stealth modification. So the King’s College team developed an immunologically-inert, doxycycline-inducible gene delivery system to controllably deliver ChABC to injured tissue caused by spinal cord injury.

Using this antibiotic to regulate ChABC gene expression, the researchers were able to study the temporal effects of doxycycline-induced ChABC treatment.

They found that even short-term treatment is sufficient to gain improvements in ambulation. An assessment of forelimb function requiring the treated rats to walk

across a horizontal ladder (a task necessitating sensorimotor integration, according to the study authors), demonstrated improved performance after doxycyclineinduced ChABC treatment compared to controls.

Paw placement is more accurate in animals treated with doxycycline-induced ChABC. One-week post-injury, injured rats in the control groups of the study slipped on 81% of their steps, compared to just 51% in those rats given the doxycycline-induced ChABC therapy.

Sustained doxycycline-induced ChABC treatment was found to promote recovery of skilled reaching following cervical contusion injury. All the rats in this study were able to pick up a food pellet in a single reaching movement prior to injury, and all rats were unable to do this one week after spinal cord injury. However, rats in the long-term doxycycline-induced ChABC treatment group improved over time, with improvements over all other treatment groups emerging around four weeks post-injury and continuing thereafter. Eight weeks on from sustaining the spinal cord injury, rats with long-term doxycycline-induced ChABC

treatment had a 43.4% success rate at this task, more than double that of any of the other treatment groups. Rats in this group successfully retrieved the pellet almost three times faster than those in the short-term doxycycline-induced ChABC group; this led the study authors to conclude that sustained administration of doxycycline (for eight weeks) may be required to provide sufficient CSPG digestion for significant neuroplasticity of descending systems involved in skilled reaching.

Burnside et al found that short-term doxycycline-induced ChABC treatment is sufficient to confer increased sensory neurone conduction. Eight weeks after spinal cord injury, both long-term and short-term doxycycline-induced ChABC treated rats had significantly improved sensory fibre conduction, with a 70.4%±2.3 and 69.3%±4.4 increase, respectively, in the percentage of axons able to conduct through the injury site.

However, only long-term treatment led to an increased density of the presynaptic excitatory marker vGlut1+. The authors write that this indicates that “long-term CSPG digestion promotes enhanced innervation by descending motor pathways”.

Burnside et al conclude their work on a positive note: “This preclinical study could have a significant impact for tetraplegic individuals, for whom recovery of hand function is an important determinant of independence, and supports the ongoing development of chondroitinase gene therapy towards clinical application for the treatment of spinal cord injury.”

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Advertorial

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Camber Spine: Bringing innovative, surgeoninspired technologies to the MIS spine market Camber Spine: where others see problems, we see opportunities. Transforming surgeon frustrations into innovations.

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ounded in December 2010 by Medtech industry and our line of SPIRA™ products with Surface By veterans Daniel Pontecorvo, Robert Morris and Seth Design™ inspired us to combine their defining attributes to Anderson, Camber Spine (Wayne, Pennsylvania, create this next generation ENZA™-A Titanium ALIF.” USA) is a privately held, self-funded company dedicated to ENZA™-A Titanium ALIF is an interbody fusion device creating surgeon designed solutions in minimally invasive consisting of a 3D printed titanium body with a roughened surgery (MIS) and to providing minimally disruptive access surface that encourages bone growth onto the cranial and for the treatment of spinal pathology. The fast-growing caudal surfaces of the device. The upper and lower faces are musculoskeletal implant company brings innovative, bestdeliberately designed with pores that average 500 microns in-class products to the market, providing surgeons and in diameter, the optimal environment for bone to grow and their patients with better treatment options. To this end, the fully incorporate the implant with the vertebral bodies. The company is committed to delivering surgeon inspired new ENZA™-A Titanium ALIF has multiple openings to allow technologies to the spinal market. a large volume of autogenous bone graft to be easily packed Following its first product launch in 2012, Camber Spine into the implant to further facilitate fusion. Similar to the Technologies has successfully launched ten product systems, original ENZA™, this device features two sharpened anchor and as of 2018 has 14 FDA 510(k) clearances and over 26 plates that are housed within the 3D-printed body until they active or issued patents. Camber Spine’s diverse portfolio are deployed into the adjacent vertebrae to provide fixation. boasts two highly innovative proprietary Product Platform According to Seth Anderson, Executive Vice President Technologies: ENZA™ and SPIRA™ OA (Open of New Business Development and Surgeon Relations, Architecture). Camber Spine’s flagship “ENZA™-A Titanium ALIF was designed with products with each of these technologies the surgeon, operating room staff, and safety are both ALIF’s with line extensions in mind. Surgery time is reduced by the under development. In addition, the single, inline instrumentation used to company has a broad and growing insert the device, deploy the anchor portfolio of fusion products. plates, and lock it in place. Patient Jason Cianfrani, Vice President safety is increased by minimising Engineering and Product Development the size of the incision and at Camber Spine, explains to Spinal retraction required for implantation News International how Camber Spine’s of the device. With ergonomic product offering is disruptive: “Camber instrumentation, this system is easy Spine offers a full range of spine implants, the to use and makes implantation more most unique and disruptive being the SPIRA Open streamlined.”

Matrix family of fusion implants and the new The Camber Spine ENZA™-A Titanium ENZATM-A MIS ALIF implant with integrated ENZA™-A ALIF is indicated for use with autogenous fixation. Both systems include Camber’s bone graft in patients with degenerative disc Surface by DesignTM 3D printed titanium surface technology disease (DDD) at one or two contiguous levels from L2 to with optimised porosity and texture. SPIRATM takes the S1. It is intended to be used with additional FDA-cleared advantages of 3D printing technology a step further with supplementary fixation systems. These implants may be its open architecture, which allows the entire implant to implanted via a laparoscopic or an open anterior approach. participate in the fusion process. The open matrix geometry Speaking of the importance of minimally invasive of SPIRATM maximises the overall exposed surface of the surgery, Cianfrani says, “Minimally disruptive access or MIS implant to allow bone to grow onto and through the implant surgery is important in a few ways. MIS surgery reduces the while also creating a broad contact area between the implant collateral soft tissue damage caused by gaining access to the and the adjacent endplates. The design features of SPIRATM spine. The smaller access window typically reduces the size can only be manufactured using the latest Titanium 3D of the incision and the amount of scar tissue formed around printing technology. the surgical site. MIS surgery also reduces surgery time “ENZATM-A is a unique implant which allows surgeons which correlates to less blood loss and fewer complications. to perform an ALIF procedure through a small minimally Finally, MIS surgery may ultimately allow more procedures invasive access window. The integrated fixation can be to move to outpatient facilities which reduces cost. deployed without any further retraction and in one simple “While we also offer other MIS style products, step. The entire ENZATM-A system was designed to ENZATM-A is our flagship MIS fusion device and, as minimise the complexity and number of steps involved with mentioned, we are currently working to apply this special a typical ALIF procedure in order to reduce surgery time, technology into a broad variety of clinical applications.” blood loss, and improve patient outcomes.”

Here, these two products are discussed, illuminating SPIRATM Open Matrix ALIF device and how Camber Spine transforms surgeon frustrations into SPIRATM-C Open Matrix Cervical innovations.

Interbody device The second flagship product amongst Camber Spine’s The ENZATM-A Titanium Anterior Lumbar offerings is the SPIRATM Open Matrix ALIF device, which

Interbody Fusion system

Most recently, Camber Spine Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its ENZATM-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation.

Daniel Pontecorvo, Camber Spine co-founder and CEO, said of this development, “ENZA™-A leverages two of Camber Spine’s highly innovative platform technologies.

The vast interest and success of our first generation ENZA™ (PEEK) with Duo Presa™ (Two Grips) anchor technology

gained FDA 510(k) clearance in August 2017 for use in skeletally mature patients with DDD at one or two contiguous levels from L2S1. Following this clearance, the company announced a second FDA approval in SPIRATM-C December 2017 for its SPIRATM-C Open Matrix Cervical Interbody device.

This latter device is indicated for use at one or two contiguous levels in the cervical spine, from C3–C7, in skeletally mature patients who have had six weeks of non-operative treatment for DDD with up to grade one spondylolisthesis. Just as with the ENZATM-A Titanium ALIF system, the SPIRATM-C Open Matrix Cervical Interbody device utilises Surface By DesignTM technology, as well as the company’s signature arched design.

Camber Spine believes its interbody implants represent the next generation of open architecture: 3D printed, titanium implants designed to encourage fusion. The combination of smart science and smart surfaces merged with SPIRA™ Arch Technology create an optimal environment for cell proliferation and bone growth.

Pontecorvo comments, “Engineers and designing surgeons leveraged the latest in 3D printing technology to incorporate the needs at each step of the fusion process.

Significant friction was achieved with the unique surface design to enable immediate stability. For short-term stability, other features were added to the surface design. This includes both a roughened titanium surface designed to promote bone cell proliferation, and a pore size optimised for bone ingrowth. In a way, robust ingrowth achieves a ‘mechanical fusion’, where we expect patients to feel better quicker.”

“Lastly, long-term stability is achieved with the ultimate endplate-to-endplate fusion. The newly forming bone follows the multiple arches incorporated with the Surface By Design™ to encourage on-growth and ingrowth throughout the cage. Also, using a key bone-growth principal called ‘Wolff’s Law’, the arched design structure enables the distribution of load and strain, helping to encourage the fusion.”

Cianfrani adds, “SPIRATM is a special product. We have received feedback from a number of surgeons who are reporting that their patients feel better faster when they use our SPIRATM implants. Camber is working to examine why our surgeon customers keep coming back to us with similar reports. With the help of the top researchers in the country, we plan to take SPIRATM to the next level by using biologic, biomechanical, and clinical data to help spread the word on SPIRATM. With reported outcomes as good as we have seen, it is important that we do our best to get this product into as many hands as possible.”

SPIRATM

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Physician burnout

Reducing physician burnout: First destigmatise, then organise Todd J Albert is surgeon-in-chief at the Hospital for Special Surgery, New York, USA, and is the current president of the Scoliosis Research Society (SRS). At the 25th International Meeting on Advanced Spine Techniques (IMAST; 11–14 July, Los Angeles, USA), hosted by the SRS, Albert gave a stirring keynote address hoping to contribute to and widen the ongoing global discussion concerning physician burn out, and advocating for the adoption of certain individual- and institution-level interventions to help lessen the strain on surgeons’ mental health.

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Todd J Albert

ental health is a significant concern for physicians. In the USA, there are 400 physician suicides a year; twice the suicide rate of the general American population.

Death by suicide is the second leading cause of death among medical residents.

Fifty-four percent of doctors say they are burned out; 88% acknowledge they are moderately to severely stressed, and 59% of doctors say they would not recommend a career in medicine to their children.

These statistics are the result of recent research by Tait Shanafelt (Mayo clinic; Stanford Medicine, Stanford, USA) and colleagues, where the investigators surveyed almost 7,000 physicians.

The same study reveals that between 2011 and 2014, there was an increase in the percentage of physicians reporting burnout, and a decrease in the number of surgeons who believed they experienced a good work-life balance. North American orthopaedic surgeons rate in the lowest third of all care workers for work-life satisfaction, and the highest for rates of burnout.

Albert opened his keynote address by defining the problem. He cited the American psychologist Herbert Freudenberger’s definition of burn out, which first appeared in print in a 1974 issue of the Journal of Social Issues, as, “A state of emotional, mental and physical exhaustion caused by excessive and prolonged stress. It is a chronic process of energy expenditure without appropriate periods of recovery.”

“A lot of us went into medicine because we wanted to be like Marcus Welby [a kindly doctor in the eponymous American TV drama]—we did not want to care about finances, we just wanted to take care of people. And that feeling led to incredible respect and trust over the last century of patients for their doctors, but the question is: are we a little out of balance? With physicians having such altruistic intentions, we burden ourselves with incredible professional responsibilities, and ignore our own health, as well as that of those around us. Many of us have been trained by role models who

work sick hours and will do research night and day.”

Like many physicians, Albert has experienced first-hand the effects of burn out: a trauma surgeon in Albert’s hospital in New York died by suicide at the end of 2017, which Albert described to the IMAST audience as “devastating for the people of our hospital.”

Michael Weinstein, a general surgeon at Thomas Jefferson University Hospital, Philadelphia, USA, who worked closely with Albert, wrote a first person account of his struggles with dysthymia, depression and suicidal ideation in the New England Journal of Medicine. Weinstein wrote: “My work lost meaning; I was just going through the motions. I thought everything I tried to accomplish was a failure. I had trouble relating to patients and felt the urge to avoid encounters altogether. I cared less and less about anything I was doing. I didn’t know it then, but I had long experienced classic signs of burnout: emotional exhaustion, depersonalisation, and low perceived personal achievement. But the burnout had been waxing and waning for 22 years; now I was in the worst episode of major depression of my life.”

Upon reading this article and realising that his friend and colleague had a history of struggling with poor mental health, Albert said, “He was the most emollient guy, I thought I knew him really well; I was shocked when I read this article [to find out] that he was admitted to a psychiatric institution three times for potential suicide. That to me is the biggest point I can make to you: recognition and sensitivity of those around us, who we work with; try and reach out and help.

I felt terrible when I read this—that I was close to him for a long time, and really did not know this about him.”

This recognition is crucial: acknowledgement of physician burnout saves lives, and is the first step to recovery.

Academic medical centres are starting to pay more attention to physician burnout and suicide, but it is still rare for a practicing doctor to be as forthcoming as Weinstein, or for mental health issues to be given the platform Albert provided at IMAST. The myriad solutions to this problem revolve around understanding the causes of physician burnout. Writing in the Journal of Internal Medicine in June 2018, Colin West and co-authors claim that the “drivers of this epidemic are largely rooted within healthcare organisations and systems,” and include: “excessive workloads, inefficient work processes, clerical burdens, work-home conflicts, lack of input or control for physicians with respect to issues affecting their work lives, organisational support structures and leadership culture.”

However, there are ways to help those struggling with chronically low mood,

and in some cases to avoid the feeling of burnout altogether. Albert concluded his keynote address with an overview of some of the options, saying, “Treatment falls into two main categories: physician directed, or organisation directed. Both are important and can make an impact.”

Amongst the physician directed solutions mentioned were cognitive behavioural therapy, wellness techniques, and coping mechanisms. Albert is one of many to argue in favour of teaching physicians these techniques to build up mental resilience; wellness training could be incorporated into university curriculums. Albert said in his speech, “I think the most important thing is for us as leaders, in whatever team we are in, to destigmatise the problem of somebody having these psychological issues, and create a safe and caring environment where it is safe to come forward and get treatment” (research has shown that orthopaedic surgeons are among the least likely to seek professional help).

The organisation directed treatment options that Albert listed included a reduced workload for physicians, improved team work, and increased help with hospital bureaucracy. In the summer of 2017, Stanford Medicine (Stanford, USA) created a chief physician wellness

54% of doctors say they are burned out; 88% acknowledge they are moderately to severely stressed officer position, the first to exist in the USA—Shanafelt was hired to fill the role on 1 September. At the time of his appointment, a Stanford Medicine press release reports Shanafelt commenting: “I think most health care leaders now realise this is a threat to their organisation, but there is also uncertainty that they can do anything effective to address it. They say, ‘It’s a national epidemic, what can we do?’ My experience has shown that an individual organisation that is committed to this at the highest level of leadership and that invests in well-designed interventions can move the needle and run counter to the national trend of physician distress and burnout.”

A wealth of literature also points to the fact that the well-being of physicians is linked to how well they can do their job: physicians who are burnt out are more likely to make errors. According to research by Shanafelt and colleagues at Stanford Medicine, physician burnout is at least equally responsible for medical errors as unsafe medical workplace con-

ditions. Physicians experiencing burnout are also more likely to report having made a major medical error in the past three months than those who have not experienced burn out. Reducing physician burnout and promoting self-compassion among healthcare workers is therefore good for a healthy society.

Another treatment strategy Albert offered in his IMAST address, originally suggested by Shanafelt, is to increase the amount of help physicians have on the job. In a study conducted by investigators at Colorado University, the average number of assistants per healthcare provider was increased from 1.1 to 2.5. The rate of reported burnout decreased from 53% to 13%. Citing the estimated US$15–55 million cost of burnout at Stanford, Albert claimed that this increase in assistance is cost effective.

Albert also suggested alternative forms of compensation as a method of combating burnout. He said, “We can change the way that we pay people. We could use discretionary pay, give people time to take care of themselves, and allow people to do things that make them feel better, through their pay and their compensation.

I think we should implement a multifaceted wellness and resiliency programme, not only in residency, but in our professional units for our staff and the ancillary providers. At the Hospital for Special Surgery, we have a wellness calendar; for every season, there is a list of wellness tasks, including meditation and a wellness book club. Self-care is very important: if you do that, your interpersonal relationships and your professional relationships are cared for; you will have better physical health, better mental clarity, better wellbeing, a stronger sense of meaning and purpose, and your patients will do better.”

Albert’s colleague Weinstein concluded his account of his experiences with burnout on a hopeful note. He wrote: “I have been open about my illness and, though I had feared re-entry, I returned to a supportive and compassionate group of co-workers. I have learned that many of us suffer in silence, fearing the stigma associated with mental illness. I feel compelled to share my story, which I have found offers others an opening to express their own suffering. I believe that by deploying tools for reflection and self-care and working together in a brave and disciplined way, we can remove our restraints and isolation—both figurative and literal.”

With his keynote address to the IMAST audience, and with an opening session at the upcoming SRS Annual Meeting (10–13 October, Bologna, Italy) focusing on physician well-being, Albert is part of a growing movement aimed at destigmatising mental health issues and reducing rates of burnout amongst healthcare workers.

P-15 Peptide Enhanced Bone Graft

The evidence-based evolution of bone graft

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2 3,4

5

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SPINE 1 ACDF w/ allograft interbody (n = 319, IDE) ACDF • 319 patients • “i-FACTOR subjects demonstrated higher overall success rate than control (autograft) subjects (68.75% and 59.94% respectively, P = 0.0382)” 2 PLIF w/ autograft mix (n = 98) PLIF • This RCT indicates i-FACTOR being significantly superior to allografted bone in enhancing intertransverse fusion (p = 0.000) 3 ALIF w/ PEEK interbody (n = 110) ALIF • 110 patients • “…high fusion rate and clinical improvements comparable to the published results for ALIF using autograft or BMP” 4 PLIF w/ carbon fiber reinforced polymer interbody (n = 40) PLIF • 40 patients • “i-FACTOR is associated with faster formation of bridging bone when compared to autologous bone in patients undergoing PLIF” ORTHOPEDICS NON-UNION 5 Treatment of non-union and delayed union (n = 22)

Level 1 Prospective Study

Published Case Series

For more information visit us at EUROSPINE stand 19G or visit www.cerapedics.com ML-0537 08/18

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Interview

Profile

Frank Kandziora

Once an aspiring architect, Frank Kandziora has never looked back from the medical profession since being assigned a medical assistant during his military service in Germany. As the outgoing president of EUROSPINE, he reflects on the successes of the past year, as well as the biggest challenges facing spine surgeons today.

When did you first know you wanted to go into medicine, and what specifically drew you to spine surgery?

When I graduated from high school, I wanted to become an architect. At that time, it was mandatory for every young male in Germany to enter the army. By chance, I was assigned to the medical service and became a medical doctor’s assistant. I was fascinated by his work and his way of helping people, so I decided to become a doctor myself.

My first contact with spine surgery was shortly after I graduated from university. I had the opportunity to participate in a transoral odontoid resection, carried out by my first mentor, Professor Kerschbaumer. In those days, this was a very special surgery and the operating room was overcrowded with visitors. I was tremendously impressed by this high-level surgery, and I decided that I wanted to be able to do that “super-challenging-spinething” on my own.

Have you had important mentors throughout your career? What have they taught you?

There have been two very important persons in my career: Professor Fridun Kerschbaumer, the orthopaedic surgeon from the Goethe University in Frankfurt who supervised my doctoral thesis, was a brilliant surgeon who had an unrivalled and elegant technique. I tried to learn as much as possible from him.

Professor Norbert Haas, the trauma surgeon from the Humboldt University in Berlin who supervised my PhD thesis, was the most important trauma surgeon in Germany for more than a decade. He not only taught me surgery, but also showed me how health systems and medical politics work. I owe a lot to both of them.

What is your proudest career achievement to date and why?

As Head of the Spine Department at the BGU hospital in Frankfurt, I am tremendously proud to lead the “best spine team in the world”.

Can you describe a particularly memorable case?

There are many memorable cases every year. But so far, this year’s most remarkable case was a young female teacher in her mid-twenties, who was suffering from a Klippel-Feil Syndrome and Arnold-Chiari II-malformation, previously operated on elsewhere, resulting in an increased cerebellar tonsil herniation, a more severe myelopathy and an implant dislocation. When I first saw her, she was unable to walk, hardly able to sit and not able to write her name. Months after performing a revision surgery, this lady recovered extremely well—she is now walking and dancing again (tango is her hobby) and is fully back to work. It is always fascinating to see the potential for spinal cord recovery, especially in young patients.

How has the field changed since you started your career?

On the one hand, spine surgery in general has become much safer, because it has become much more common, but on the other hand it also has also become much more complex. Twenty years ago, spine surgery was only

performed in a few highly-specialised hospitals. Nowadays, we have a lot of well-educated spine surgeons doing a wonderful job and making spine surgery safe and efficient. However, the increasing case load has also resulted in a substantial number of devastating failures and more complex revision surgeries. Taking special care of these cases is now one of our major challenges.

Outside of your own research, what is been the most interesting paper that you have seen in the last 12 months?

In my opinion, the best paper in 2017 was presented

by Anne Mannion from Zurich, Switzerland at EUROSPINE 2017, demonstrating that outcomes after spine surgery are still poorer overall than outcomes for large-joint replacement. Her paper shows that a lot of work is still required to optimise indications and patient selection criteria for spine surgery. It was awarded the EUROSPINE Full Paper Award and published in the European Spine Journal.

In your opinion, what are the most exciting new developments in spine surgery that we can expect in the next five to ten years?

In the last two decades, many potential “eruptive innovations” in the implant manufacturing field have proven to be ineffective. As a result, the regulations for new implants, especially in Europe, have already become or will fortunately become much stricter. Hence, I am convinced that the speed of innovation in this area will decrease dramatically during the next decade.

Therefore, the most exciting clinical developments will hopefully result from a more evidence-based spine surgery approach and an improvement of the surrounding conditions, raising the quality and safety of spine surgery.

What is the biggest challenge in spine surgery at the moment?

The biggest challenge in spine surgery in developed countries is the demographic change with a growing aging population. With increasing age, the number of, for example, degenerative spinal disorders and osteoporotic fractures resulting in disability will continuously grow.

This necessitates an adjustment of our resources to ensure that this increasing number of patients can still be treated adequately. I am convinced that there is already a need for a general society-based discussion about what we should do and how much we can afford to do.

For your habilitation, you studied the influence of cage design, carrier systems and growth factors on interbody fusion. What was your most interesting finding from this research?

The most interesting, but also slightly disappointing, finding in this research was that it is now possible to create a “perfect laboratory implant” by combining growth factors with carrier systems and optimised cages which guarantees(!) fast and secure spinal fusion. Unfortunately, bringing such innovative technology into the clinic, and especially to the individual patient, is tremendously complicated due to financial, logistic, technical and legal obstacles.

Could you explain your current research interests?

My current research interests focus on spine trauma and minimally invasive spine surgery. The most recent study we ran, published in the European Spine Journal, was a randomised controlled trial comparing posterior with posterior-anterior stabilisation of thoracolumbar burst fractures.

It is also a great honour and a pleasure for me to be part of the large research network, AOSpine Knowledge Forum in Spine Trauma, which, for example, has most recently described and validated new classification systems for all spinal injuries, known as “AOSpine Classifications”.

As a specialist in trauma surgery, what are the biggest challenges facing this field right now, and have these changed over your career?

The biggest challenge in the field of spine trauma surgery is once again our aging population. While 10 years ago the number of patients over the age of 80 treated surgically for highly-unstable spine fractures in my depart-

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Interview

ment was less than 2% of all spine fractures, today this rate has increased to nearly 10%. Severe spinal fractures in old, multi-morbid, often poly-traumatised and typically osteoporotic patients, is by far the biggest challenge we are currently facing in spinal trauma surgery.

You are the current President of EUROSPINE. What have been the highlights of this position, and what do you like most about this organisation?

EUROSPINE is a healthy organisation that is continuously growing and evolving to advance spine surgery in Europe. With more than 8,000 members and associate members, it is by far the largest spine society in Europe and perhaps even the largest truly international spine society in the world. What I like most are the people that form this organisation. They are the “crème-de-la-crème” of European spine specialists and it is a great honour and a pleasure to be one of them.

So far, my personal highlight this year was the memorandum of understanding (MoU), that we signed with EANS, as well as with EFORT. This MoU helps us to align spinal education throughout Europe, together with our neurosurgical and orthopaedic colleagues. As a result, regardless of whether you attend a EUROSPINE, an EANS course or a course presented by the German, Turkish or the Spanish spine societies, under the equivalence programme you would qualify to receive the EUROSPINE Diploma, or EUROSPINE Advanced Diploma.

This is a tremendous step forward in achieving a homogeneous, Europe-wide training programme for spine specialists.

Having been a long-term Board Member of the German Spine Society, you are now their President Elect—what are your ambitions for this role?

The German Spine Society has made a tremendous development

since its founding in 2005. It is currently the largest national spine society in Europe, with a well-recognised education and quality-assurance programme. My main role will be to continue this excellent development and boost the international role of the German Spine Society.

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Fact File

As a surgeon in Germany, how does the German healthcare system help and hinder your research and/or practice?

The German healthcare system is one of the best in the world. In general, it allows me to provide excellent spine care to everyone in the country, because everybody is insured. On the other hand, the numbers of spine surgeries have increased, resulting in political pressure reflected by media campaigns complaining about too many and potentially unnecessary procedures.

This has dramatically affected the surgeon-patient relationship, which is the basis for all we undertake. I think it is important to rebuild trust by improving the evidence in spine surgery and demonstrating that there are clear reasons for the increasing numbers in surgical procedures, which are predominantly the aging population and improved treatment options.

As a member of the editorial board for several journals, what do you think makes a good original research article?

A good original research article is characterised by an intelligent idea, an interesting research question, up-todate methodological techniques, an adequately-powered research population and honestly-presented results. If this results in a “game-changing” conclusion, please submit your work to EUROSPINE to receive one of the awards we offer.

There is still gender disparity among the top researchers in spine. How well do you think institutions are doing to encourage more women to pursue a career in spine, and could this be improved?

Although the gender gap in university medicine has decreased over the last two decades, at least at the universities where I was teaching, unfortunately not enough women end up in spine research or spine surgery. While other specialties such as anaesthesiology, gynaecology, or ophthalmology and even “exhausting” general surgery are made up of more than 50% female surgeons, women are still an exception in “spine”. We have already taken measures to improve this situation, such as optimising and adapting working hours and conditions, allowing pregnant surgeons to perform operations, etc., but still only 18% of my colleagues are female. I am not really sure how to further improve the situation, but I am open to any suggestions and very happy to accept female applications for positions in my department.

What advice would you give to someone wishing to start their career in spine surgery?

I think it is absolutely mandatory to love what you do.

Spine surgery is a sometimes physically exhausting, often challenging and always interesting mission with long working hours and hopefully only a few setbacks.

Therefore, you need love and passion to be successful.

But if you really love it, it will be highly rewarding because your work will become your hobby, making you happy every time you work. If you are happy, you will be able to make others happy too.

So, if you love “spine”, then go for it, because it is your chance to make yourself and many others happy.

What are your interests and hobbies outside spine?

Like many others, I have a soft spot for gourmet food and excellent red wine. However, my favourite hobbies are studying archaeology and reading historical books.

Current roles

Professor, teaching at Wolfgang Goethe University, Frankfurt, Germany Chairman, Centre for Spinal Surgery and Neurotraumatology, BG Hospital, Frankfurt, Germany President, EUROSPINE

Education

2003–07: Head of the Spine Unit, Center for Musculoskeletal Surgery, Campus Virchow, Charité University Hospital, Berlin, Germany 2003–07: Consultant, Center for Muscoloskeletal Surgery, Charité University Hospital, Berlin, Germany 1998–03: Training in Spine-, General-, Traumaand Orthopedic Surgery, Charité University Hospital, Berlin, Germany 1996–98: Training in Orthopaedic Surgery, Wolfgang Goethe University, Frankfurt, Germany 1990–96: Studies of Medical Science, Johann Wolfgang Goethe-University, Frankfurt, Germany 1988–90: Medical service, German army

Society roles (selected)

Incoming President and long-term Board Member of the German Spine Society Former Chairman of the “Spine Group” of the German Orthopedic and Trauma Society Board Member of the German Orthopedic and Trauma Society Congress-Ambassador of the city of Frankfurt, Germany Member of the AOSpine Technical Commission Former Member of the AO Clinical Investigation and Documentation Advisory Board Chairman and long-term Member of the AO Computed Assisted and Image guided Surgery Expert Group and Access and Navigation Expert Group

Awards (selected)

2016: Best Paper Award, Global Spine Journal, Milan, Italy 2007: Best Oral Presentation, SBOT, Sao Paulo, Brazil 2006: Best Poster Award, ARGOS International, Paris, France 2004: Mario-Boni Award, Cervical Spine Research Society (ES), Porto, Portugal 2004: Ferdinand-Sauerbruch Award, Berlin Society for Surgery, Berlin, Germany 2002: Hans-Liniger Award, German Trauma Society, Berlin, Germany

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Sept

Few patients maximise opioid-sparing medications after orthopaedic surgery A new study led by Johns Hopkins researchers adds to growing evidence that patients underuse nonopioid pain relievers to supplement opioid pain management after spine and joint surgery.

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report on the findings, which also shows that patients improperly store and dispose of unused opioids, was published in the journal Anesthesia & Analgesia. The report highlights the need for physicians to better educate patients on non-opioid alternatives as well as how to properly store and dispose of opioids in the home, the investigators say.

“We found that a very small percentage of patients use non-opioid medications such as ibuprofen and acetaminophen in addition to opioids to help manager their pain,” says Mark Bicket (Department of anesthesiology and critical care medicine, John Hopkins University School of Medicine, Baltimore, USA), the paper’s first author.

“It’s clear we need to empower patients to ask their physicians about non-opioid pain management options, as well as call on prescribers to be more thoughtful of their prescribing practices,” says Bicket.

Bicket adds that if pain is more frequently managed with non-opioid options, fewer opioids will need to be

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Opioids

prescribed and patients will have less available to be lost, sold, taken by error or accidentally discovered by a child.

In one of Bicket’s earlier studies (JAMA Surgery, 2017), he reviewed half a dozen studies and found that most opioid pills prescribed after surgery went unused, and almost all patients failed to properly dispose of the leftovers.

To further examine what happens to opioid pills after they are prescribed, as well as to determine whether patients used non-opioid medications in conjunction with their prescribed opioid prescriptions as recommended by evidencebased guidelines, the researchers recruited 140 inpatient adult spine and joint surgery patients at The Johns Hopkins Hospital from August to November 2016. Of the 140 patients in the study, 47% were women, the average age was 56, 58% reported a history of chronic pain and 74% were Caucasian.

Bicket and his team collected patient data such as history of substance abuse, self-reported pain scores and preoperative opioid use through in-person interviews and electronic health records.

The researchers also conducted phone surveys after surgery at two days, two weeks, one month and six months to determine if and when patients stopped taking opioids, how many opioid tablets they had left, what other non-opioid pain treatments they used, and their knowledge and practice regarding safe opioid storage and disposal per the Food and Drug Administration’s (FDA) recommendations.

Of these patients, very few used nonopioid medications in conjunction with opioid products throughout the study period. Two days after surgery, 82% of patients reported not using nonsteroidal

anti-inflammatory drugs (NSAIDs) and 44% reported not using acetaminophen.

Only 5% used both NSAIDs and acetaminophen. One month post-surgery, only 6% of patients reported use of multiple non-opioid medications.

One month post-surgery, 73% of patients said they had unused opioids, 46% said they had 20 or more unused pills, and 37% said they had more than 200 morphine milligram equivalents (MMEs) of opioids.

While it is difficult to definitively say how many MMEs are dangerous to take at one time, Bicket says 200 MME is considered by some experts as the dosage at which a patient who has never had opioids would overdose.

The majority of patients also reported unsafe storage (91%) and failure to dispose of (96%) opioids one month after surgery, as suggested in FDA guidelines.

Six months post-surgery, the percentage of patients who had unused opioids fell to 34%. Many still reported unsafe storage and failure to dispose of opioids (92% and 47%, respectively), with a large majority reporting they had not received instructions on how to store or dispose of opioids (83% and 75%, respectively).

Other authors on this paper include Elizabeth White, Peter J Pronovost, Christopher L Wu and G Caleb Alexander of the Johns Hopkins University; and Myron Yaster of Children’s Hospital Colorado (Aurora, USA).

Sustained use of opioids before spine surgery increases risk of continued use after surgery Patients who take prescription opioids for a longer period before spinal surgery are more likely to continue using opioids several months after surgery, reports a study in The Journal of Bone & Joint Surgery.

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ccording to the new research, led by Andrew J Schoenfeld (Brigham and Women’s Hospital, Harvard Medical School, Boston, USA), nearly 9% of patients were still taking opioids six months after spinal surgery, and duration of opioid use before surgery was the main risk factor for continued use.

Sustained preoperative opioid use predicts continued use after spine surgery Using insurance claims data, the researchers identified more than 27,000 patients who underwent various types of lumbar spine surgery between 2006 and 2014.

Most of the patients underwent a discectomy or spinal fusion procedure. Although the data came from the US Department of Defence’s Tricare insurance program, most of the patients in the study were civilians (such as retired military personnel or dependents of active-duty or retired personnel).

Nearly all patients had at least some opioid exposure before spinal surgery. They were classified into four groups: Exposed: 60% had used opioids in the past, but were not actively using them at the time of surgery.

Acute exposure: 34% had their first opioid prescription within one month before surgery.

Intermediate sustained use: 2% had uninterrupted opioid use for less than six months before surgery.

Chronic sustained use: 3% had uninterrupted opioid use for six months or longer before surgery.

After surgery, 67% of the patients stopped taking opioids within 30 days, and 86% discontinued opioids by 90 days. Six months after surgery, 8.8% of patients

were still taking prescription opioids.

Longer duration of opioid use before spinal surgery was an independent risk factor for continued use after surgery. After adjustment for other patient characteristics, the authors found that the likelihood of discontinuing opioid use within six months was 65% lower for patients in the “intermediate sustained” and 74% lower in the “chronic sustained” groups, compared to the “acute exposure” group. Somewhat surprisingly, even the patients who were “exposed” but not actively using opioids before surgery were 29% less likely than those in the “acute exposure” group to discontinue opioids after surgery.

Several other factors were associated with long-term opioid use after surgery: spinal fusion surgery, preoperative depression or anxiety, preoperative spinal fracture, a longer hospital stay, and junior enlisted rank (suggesting lower socioeconomic status).

The ongoing opioid crisis in the USA has prompted increased attention to the use of pain medications prescribed before and after surgery. Previous opioid use has been linked to an increased risk of complications and adverse outcomes after spinal surgery. This new study focuses on how preoperative opioid use affects continued opioid use after lumbar spine surgery, and finds evidence of a “dose-response” effect: patients taking opioids for a longer period before surgery are less likely to discontinue opioid use after surgery.

“Our results indicate that the majority of patients who are using prescription opioids prior to spine surgery discontinue these medications following surgical interven-

tion,” Schoenfeld and co-authors write. However, because close to one out of 10 patients are still taking opioids at six months after spinal surgery, the researchers highlight the need for surgeons to recognise the “biopsychosocial” factors contributing to chronic opioid use.

Since nearly all patients receive opioids before spinal surgery, Schoenfeld believes it’s “reasonable” for surgeons to discuss risk factors for sustained opioid use with patients at the time of surgery. He adds, “Expectation management—defining shared goals of post-surgical pain control and a suspense date when the surgeon and patient agree opioids should likely no longer be necessary—could go a long way toward smoothing the opioid cessation process following surgery.”

Additionally, a recent Spine study presented at the 18th annual conference of the International Society for the Advancement of Spine Surgery (ISASS; 11–13 April 2018, Toronto, Canada) found that patients who have been taking opioids as pain relievers for several months before spinal fusion surgery are at increased risk of complications after their surgery.

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Opioids

Opioid dependence in patients with degenerative spondylolisthesis more likely to occur before than after surgery “Decompression and fusion for degenerative spondylolisthesis is associated with reduced risk of opioid dependency”, says Mayur Sharma (Department of Neurosurgery, University of Louisville, Louisville, USA), summarising his latest research, recently published in the Journal of Neurosurgery: Spine. The study reports that degenerative spondylolisthesis patients are more likely to have a dependency on opioid medications before surgery than afterward.

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n the midst of the US opioid epidemic, identified as a national emergency, Sharma and colleagues set out to investigate the risk factors for the development of opioid dependence in these patients by analysing data from MarketScan databases. In 2015, opioid overdose was cited as a cause of more than 33,000 deaths in the USA alone.

A large proportion of opioid addiction can be traced back to the misuse of physician-prescribed medications initially provided for the management of acute or chronic pain. The lower back is a common site of pain—approximately 80% of adults experience low back pain at some point in their lives. Low back pain has been cited as the leading global cause of disability.

Opioid dependence reduced after surgery After evaluating the impact of surgery, patient age and sex, comorbidities,

spondylolisthesis, these patients were twice as likely to become opioid independent than they were to become opioid dependent.

Prior to surgery, 15% (1,591) of the patients had an opioid dependency.

Between three and 15 months after surgery, however, the percentage of patients with a dependency on opioids was 10% (1,060).

For their analysis, the authors defined indicators of opioid dependence as follows: continued opioid use, more than 10 opioid prescriptions, had counselling regarding psychological and pharmacological treatment options for opioid addiction, or either a diagnosis of opioid dependence disorder or a prescription for treating opioid dependence disorder during the period of one year before or three to 15 months after surgery.

The patient cohort

and type of medical insurance held by the patients, the authors determined the following applied to patients who underwent surgery to treat degenerative spondylolisthesis: There was an association between surgical decompression with fusion and a decreased risk of postoperative opioid dependence. In this study, the opioid dependence was reduced by 5% after surgery for degenerative

spondylolisthesis (90.1% patients were opioid independent following surgery, an increase from 85.15% prior to surgery).

Preoperative opioid dependence was associated with an increased risk of postoperative opioid dependence.

Increased patient age was associated with a decreased risk of postoperative opioid dependence.

Following surgery for degenerative

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Sharma and colleagues extracted deidentified data from the MarketScan databases on 10,708 patients who had undergone surgery for degenerative spondylolisthesis. The median age of these patients was 61 years (interquartile range: 54 to 69 years). Of these, 65% were women. In most cases (94%), the surgery was decompression with fusion, and in 76% of patients, surgery involved multiple vertebrae.

Many patients (54%) had one or more comorbidities. The majority of patients had commercial health insurance (61% as opposed to 35% with Medicare).

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Sept

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3D-printed models

A novel approach to complex spinal surgeries: The successful use of 3D-virtual and 3D-printed models A novel approach reported by Peter Pijpker and colleagues from the University Medical Center Groningen, Groningen, The Netherlands, outlines the use of 3D virtual planning and 3D-printed models that have the ability to change how complex spinal surgeries are managed. Using this technique, surgeons were able to successfully reduce severe kyphosis in a young girl who suffers from skeletal dysplasia.

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ijpker et al emphasise the need for more precise methods of surgical planning. They state that a major advantage regarding the use of 3D virtual planning is the ability for the preoperative plan to correlate precisely with the actual operation: “This technology can give rise to new possibilities for the surgical planning of spinal deformities,” they wrote.

For patients with thoracic kyphosis, vertebral column resections and pedicle subtraction osteotomies (PSO) are widely indicated. To reduce the risk of injuries occurring during the osteotomy and pedicle screw insertion, computer assisted surgery (CAS) systems are commonly used. However, the procedure remains technically demanding with a risk of major complications.

Furthermore, the authors note that recent research in relation to individualised templating for spine surgery is currently limited to dill guides for accurate pedicle screw placement. Although patient-specific osteotomy templates have been described for knee arthroplasty, the authors report that this is the first paper describing this technique for complex spinal osteotomies.

The report describes the case of a young girl with severe angular thoracolumbar kyphoscoliosis. A closing wedge extended pedicle subtraction osteotomy was first virtually planned using medical computer software. Individualised osteotomy guided templates

were then designed for the translation of the planned 3D-wedge towards the surgical procedure.

The authors note that the 3D planning and templates facilitated surgery in various ways. Not only did it allow for a 3D insight into case-specific anatomy and identification of vertebrae levels (as well as malformed vertebrae visualisation) during surgery, but it enabled the direct translation of the planned pedicle subtraction osteotomy into the surgical site using 3D printed individualised osteotomy guided templates. Additionally, the surgeons reported that studying the 3D anatomy in a multidisciplinary team facilitated the surgical procedure due to enhanced spatial orientation.

In relation to the case, the post-operative period was uneventful and she was discharged without any neurological deficit after eight days. The early postoperative X-rays showed a satisfactory correction of the kyphoscoliosis, as the kyphosis angle was reduced from 74 degrees to 22 degrees and her coronal plane was normalised.

Through the successful correction of the kyphoscoliosis in this case, it is clear that the novel use of 3D-virtual planning, 3D-printed spine models and osteotomy guiding templates have facilitated the performance of the osteotomy. In the report, the authors also note that this technique is feasible for the surgery of complex spinal deformities. They write that, from the surgeon’s

A 3D-printed spine model with 3D-printed osteotomy templates (red). All images courtesy of Pijpker et al.

Postoperative X-ray showing correction of the spinal deformity. All images courtesy of Pijpker et al.

perspective: “The templates and bone models provide valuable guidance during the osteotomy in the severely deformed anatomy.”

The authors reiterate that this method of spinal correction can be cost-effective, while it may help to reduce surgery time. Furthermore, it may preclude the need for intraoperative radiography—especially when combined with patient drill guides.

However, while the templates provided great directional support for the surgeon, the authors note that the use was nevertheless limited to the first stages of pedicle subtraction osteotomy.

For example, when approaching the apex of the wedge, temporary rods had to be placed for stabilisation and safety.

As this is a novel technique, future

designs of templates can be optimised by incorporating inlets for rod-positioning. Regarding the future of this method in terms of feasibility, the authors said that current feasibility was limited to describing the technical aspects, as well as the use of this new method in a qualitative manner.

Therefore, to move forward with this technique, a comprehensive accuracy study is needed in relation to the clinical outcome; assessing its efficacy in a quantitative manner.

Nonetheless, the authors conclude by saying that, in addition to contributing to safer spinal osteotomy procedures, the novel use of this workflow involving 3D-virtual and 3D-printed models may change how complex surgeries are managed.

Immediate restoration of voluntary movement with epidural spinal cord stimulation in two patients with paraplegia In a small cohort of patients, spinal cord stimulation has been shown to restore volitional movement in select paraplegic patients, after intensive therapy. This was the result presented by winner of the Philip L Gildenberg Resident Award, David Darrow (Neurosurgery Department, University of Minnesota, Minneapolis, USA), during the 2018 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (28 April–2 May, New Orleans, USA).

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he presentation was entitled “Immediate Restoration of Voluntary Movement with Epidural Spinal Cord Stimulation in Two Patients with Paraplegia.”

The Epidural Stimulation After Neurologic Damage (E-STAND) study was designed to assess the effect of spinal cord stimulation on paraplegic patients, focusing directly on movement and cardiovascular function, while patients undergo intensive stimulator setting optimisation from home.

Participants were selected from a cohort of AIS A/B chronic spinal cord injury patients with a motor level between C6 and T10 greater than one year from injury.

Patients were required to have full strength in their up-

per extremities and have discrete spinal cord lesions on MRI. The first two E-STAND patients underwent enrollment, surgical implantation of the stimulator and paddle electrode and follow-up. Preoperative and postoperative tilt table assessments and neurological assessments were performed.

The first two patients were female and in their fifth and sixth decade of life, with complete motor and sensory paraplegia (AIS A). Initial assessment (36 hours from surgery) of spinal cord stimulation revealed restoration of lower extremity volitional movement only during stimulation in both patients, despite being 11 and five years out from surgery. Quantitative surface

EMG power was found to improve significantly for both patients within just the first five follow up visits.

Spinal cord stimulation was also found to restore normal blood pressure from severe hypotension during tilt table testing in the second patient, who had exhibited dysautonomia on screening assessments, while having no effect on the normal blood pressure of the first patient. Bowel and bladder changes were also found with restoration of volitional urination and restoration of bowel and bladder synergy.

To the authors’ knowledge, these are the first women with radiographically severe spinal cord injury this far from injury where restoration of some volitional movement and autonomic function has been reported.

The authors claim that this work provides evidence that even in the most severe forms of chronic spinal cord injury, some volitional movement and autonomic function can be restored in paraplegic patients with spinal cord stimulation neuromodulation without significant prehabilitation.

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Sex and the spine

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Sex and the spine: Breaking the taboo AREENA DSOUZA COMMENT & ANALYSIS Areena Dsouza discusses why it is important to have open discussions between surgeons and their patients about sexual function when deciding on treatment options. Along with Bronek Boszczyk (Benedictus Clinic Tutzing, Tutzing, Germany), Dsouza is co-hosting an NSpine sex and spine event at the International Spinal Cord Injury Care In Emerging India meeting (ISSICON; 05–07 October, Chennai, India).

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t is widely recognised that a range of spinal disorders can lead to sexual dysfunction.

And yet it is not a topic that is well understood or openly discussed even in a clinical setting. This can be pinned down to a number of reasons, which can vary from a lack of knowledge or discomfort felt by the medical practitioner who sees such patients, to patients not being open to the idea of disclosing such information or being unable to adequately

describe their problems.

These issues stem from some basic deficiencies in our approach as medical practitioners, and the lack of understanding of a simple fact: sex is an important aspect of daily life.

Patients appreciate simple solutions to tackle day to day issues and some dos and do nots. But sexual activity by itself does not readily feature as part of these discussions. In a recent informal survey conducted at Nottingham University Hospitals,

85% of patients presenting to the Physiotherapy Department due to back pain would have appreciated more information about how their condition could affect their sexual activity, and what steps could be taken to improve this important part of their lives.

Unfortunately, information in this respect is not readily available—for patients or clinicians.

The ‘Sex and The Spine’ platform was launched to provide a portal for education for both clinicians and patients. The multi-disciplinary team working on the platform content includes spine surgeons Boszczyk and Dsouza; clinical sexologists Angela Gregory and Martha Lee, and consultant physiotherapist Eleanor Dunstan.

The key goals of our discussions include: 1. To improve understanding of the normal physiology and psychology of sexual function and how it is affected by a range of spinal conditions from back pain to spinal cord injury.

2. To facilitate open discussions

Areena Dsouza in conversation with a sex therapist at a Sex and The Spine event

on the taboos involved and debate solutions to these problems that “no one talks about”.

3. To create open discussion forums aimed at breaking down barriers and raising awareness of patient demands and treatment strategies by health care professionals.

In the first series of recorded lectures we focus on some important discussions on normal sexual physiology, including erectile function and female orgasm, principal treatment strategies of erectile dysfunction, and positioning aids in back pain or post-surgical conditions. For patients in pain and discomfort,

these strategies aim at making the act more pleasurable rather than a task.

The recordings are intended for online access to reach as many global patients and practitioners as possible. As the platform develops we hope to create awareness of this important human topic and form a comfortable module for discussion for patients and clinicians who have traditionally shied away from talking about sex.

Areena Dsouza is a clinical spine fellow at Queen’s Medical Centre, Nottingham, UK.

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Motion in the cervical spine

Restorative motion surgery in the cervical spine: Reversing fusions and placing artificial discs TODD H LANMAN COMMENT & ANALYSIS Todd H Lanman is a spine surgeon known for his work on the advancement of total disc replacement surgery and motion preservation. Following his own experiences undergoing a number of spinal surgeries, Lanman has pursued a career dedicated to the restoration of his patients’ mobility. Here, he argues for the modernisation of cervical spine surgery by advocating for the routine use of cervical disc replacement.

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istorically, when patients had degenerative disease in the hip and knee, we surgeons fused the joints. It relieved pain, the joints were stabilised, but range of motion was terrible. As artificial knee and hip joints were shown to be safe, effective, and to greatly improve health related quality of life, we moved away from fusion and towards artificial joint replacement of these joints.

For knees and hips, artificial joint replacement is now routine. When these artificial knees or hips fail, we do not take out the artificial joint and perform a fusion, we simply replace the artificial joint with another. In fact, if the situation warranted, we would revise a hip or knee arthrodesis and place a new artificial joint.

Unfortunately, we still follow the old model for treating cervical disc disease.

In patients who have had failed artificial disc replacements, most surgeons will remove the disc and fuse the spine there.

Likewise, a cervical spine fusion is often viewed as the operation of no return. I am advocating a new approach. Instead of fusion, I suggest we remove the failing disc (or perhaps revise a fusion), fix the problem (for example bone spur) and install a new artificial disc. Essentially, I want to bring cervical spine surgery into the modern age, where knees and hips have been for some time already.

I cared for a woman from Texas who had a three-level cervical fusion from C3 to C6. She came to see me because another disc had failed at C6-C7. She was an avid golfer, and did not want any further cervical fusion surgery performed.

Her range of motion was already far more limited than she would like. She asked that I treat the C6-C7 level with an artificial disc.

She was an off label candidate for artificial disc replacement at C6-C7, below her three-level fusion. However, as we were discussing the procedure, she specifically asked whether it might be

possible to remove the fusion. At the very least, she wondered, could I revise at least one of the fusions and replace that with an artificial disc, in order to improve her neck mobility.

After reviewing her CT scan, her facet joints did appear opened and healthy behind the fused disc of C5-6—this is the disc immediately above C6-7. They were not autofused, though the interbody space was autofused at C5-C6. After careful consideration, I told her I could remove the fusion. I explained I could carefully drill this area out and provide interbody distraction. If the facet joints permitted motion, then I could insert an artificial disc. I also explained that this was an off label use of the device and explained what that meant. After a thorough discussion of the risks and benefits, she was very eager to try this surgical option. In fact, her enthusiasm and strong desire for greater spinal mobility is what initially drove me to this route.

During surgery, I was able to drill out the fusion at C5–6, and, after seeing acceptable motion, I placed an artificial disc. Now, instead of having three discs fused, her cervical spine only has two discs fused, and she has two artificial discs. She now has three motion segments of the five discs in the cervical spine, as shown on the attached films, has far greater spinal range of motion, and has less pain. By all measures, the surgery was a success.

In my practice and as a principal investigator for a number of artificial disc device trials, I have come to learn that fusing more than two levels in the cervical spine often leads to severely restricted motion. After analysing the data, reversing cervical fusions and replacing them with artificial discs provides at least equivalent and often times superior results for the treatment of degenerative cervical disc disease, and enables select patients to regain motion in the spine and

to live active and more functional lives. I have applied this technique to more than 10 patients with great success.

Of course, proper patient selection is critical. I have found that the best candidates for this procedure are those who are seeking disc replacement surgery and have failed unions called a nonunion.

During pre-surgical planning, it is critical to obtain a CT scan with very thin cuts in axial, sagittal and coronal planes. If the facet joints appear open—not autofused at the fusion segment or at a nonunion segment—the anterior cervical plate and interbody spacer can be removed safely.

Once the device is removed, it is important to carefully distract the interbody space and open it. Care must be taken as you move laterally to avoid the vertebral arteries, of course, and provide very thorough decompression of the nerve roots bilaterally. It is clear that when restoring motion, nerve root decompression is

critical and must be extensive so that the patient does not create an impingement with the artificial disc in place.

Artificial disc replacement and fusion can relieve pain and dysfunction; however, the goal of surgery should also be to restore motion, and keep the patient active and functional. Artificial disc replacement accomplishes this last feat, where fusion does not. Given my successes with the approach and the successes I have seen in clinical research, I am therefore advocating revision with artificial disc replacement both for artificial disc replacement and prior fusion surgeries in the cervical spine in select cases. Just as the field has progressed in knees and hips, so too will the management of degenerative diseases of the cervical spine.

Preoperative flexion with fusion

Postoperative flexion with artificial disc replacements

Preoperative extension with fusion

Postoperative extension with artificial disc replacements

Todd Lanman is a spine surgeon at Lanman Spinal Neurosurgery, Los Angeles, USA.

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Sept

Novel approach proves mixed reality is a feasible option for future intraoperative visualisation A preliminary study has demonstrated the feasibility of using a novel visualisation approach as a valuable adjunct tool for minimally invasive percutaneous procedures. This is the conclusion of Gerard Deib (Division of Interventional Neuroradiology, The Johns Hopkins Hospital, Baltimore, USA) and colleagues following a feasibility study, recently published in The British Medical Journal (BMJ).

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he investigators used optical see-through head mounted displays to offer a mixed reality experience with unhindered procedural site visualisation during three commonly performed minimally invasive procedures using high resolution radiographic imaging: vertebroplasty, kyphoplasty, and discectomy.

Deib et al write: “Adequate image guidance is necessary to reliably visualise anatomic landmarks and successfully deliver medical devices during percutaneous spine procedures. Radiography monitors displaying the fluoroscopic images used for guidance purposes are typically not aligned with the procedural axis, rendering an indirect visualisation shown to hinder hand-eye coordination. Optical see-through head mounted displays with high resolution and high contrast capabilities offer real time mixed reality visualisation of radiographic images that can be projected over the interventional site without hampering direct visual control of procedural manipulations.”

Percutaneous vertebroplasty, kyphoplasty and discectomy were successfully performed using the optical see-through head mounted displays image guidance on a lumbar spine phantom using commercially available devices. The percutaneous vertebroplasty and the kyphoplasty were “technically adequate”, with the study authors reporting PMMA (polymethylmethacrylate) filling 60–70% of the L2 and L3 vertebrae, endplate to endplate deposition, and an equal amount of cement on either side of the midline.

For the discectomy, the Dekompressor device was suc-

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Policy

Operator using mixed reality

cessfully placed into the mid-portion of the L3–4 intervertebral disc.

Dosimetry and procedural time for the three percutaneous operations under study compared favourably with typical procedural times. Conventional and mixed reality visualisation modes were equally effective in providing image guidance, with key anatomic landmarks and materials reliably visualised.

The authors conclude: “In this single user preliminary study, optical see-through head mounted display visualisation was not found to be inferior to traditional monitors in terms of procedural duration, dosimetry, or ability to visualise key anatomic structures, devices, or material components. There was no perceived impairment in the operator’s ability to visualise real world structures while wearing the head mounted display and using the virtual monitor display, as demonstrated by the completion of all procedural steps without removing the head mounted display, turning off the virtual monitor, or resorting to a traditional monitor.”

Mixed reality visualisation

The operator, a neurointerventional fellow with one year’s experience of vertebroplasty and kyphoplasty, obtained a clear view of the pedicle outline and the articulating processes of the facet joints during the initial set-up and planning.

Mixed reality visualisation—the merging of real and virtual worlds to produce new environments and visualisations where physical and digital objects co-exist and interact in real-time—was achieved using the Microsoft HoloLens system. The system used for real time visualisation of intraoperative medical images in the mixed reality environment could utilise any of a head, world, or body anchored display, with an average delay of 214 (±30) ms, and a refresh rate of 41.4 (±32.0) Hz for typical image sizes. Each display mode provided equally effective image guidance.

When head anchored, the mixed reality display remains at a constant position within the operator’s field of view, and depth position remains unchanged throughout the procedure.

This display was deemed especially useful at the start of the operations, when the surgeon needed to look at multiple things at once, for example, the phantom patient, the angiography C arm, and the angiography table control panel.

In contrast, the world anchored relies on the display being locked to a specific position in the environment by a hand gesture from the operator. This proved particularly helpful for visualising a single space, such as when advancing a device under fluoroscopic guidance, though as the display is stationary, it will occasionally be out of the operator’s field of vision.

Finally, the body anchored mode, though it combined the most convenient features of the world and anchored displays, required constant repositioning of the virtual monitor within the operator’s field of view, and therefore a period of acclimation to the mixed reality environment is necessary.

This display type consistently remains in a specific position within the operator’s field of view, and only moves when the surgeon’s head movement would result in the display leaving their field of vision.

Overlapping surgery decreases length of hospital stay A change in policy allowing overlapping surgery decreases length of stay in an academic, safety net hospital. This is the conclusion of Anthony DiGiorgio (Department of Neurosurgery, Louisiana State University Health Sciences Center, New Orleans; Department of Neurosurgery, University of California, San Francisco, USA), winner of the Robert Florin Award, presented during the 2018 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting (28 April–2 May, New Orleans, USA).

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s the practice of surgeons performing overlapping surgery has recently come under scrutiny, this research sought to examine the impact of hospital policy that allows overlapping rooms on surgery wait time and length of stay in patients admitted to a tertiary care, safety net hospital for urgent neurosurgical procedures.

The neurosurgery service at the hospital being studied transitioned from routinely allowing one room per day (period one) to overlapping rooms (period two), with the second room being staffed by the same attending surgeon. Patients undergoing neurosurgical intervention in each period were retrospectively compared. Case urgency, patient demographics, case type, indication, length of stay and time from admission to surgery were tracked.

Per study results, allowing overlapping rooms significantly reduced

length of stay, complication rate and increased the rate of discharges to home. This was in a vulnerable population, comprised mostly of Medicare, Medicaid and uninsured patients who were in need of urgent surgery at a single safety-net academic institution.

There were 452 total cases reviewed (201 in period one, 251 in period two), covering seven months in each period. There were 122 cases classified as “urgent” (59 in period one, 63 in period two). In these patients, length of stay was significantly decreased in period two (13.09 days vs. 19.52) and the time from admission to surgery for urgent cases trended towards a shorter time (5.12 vs. 7.00). Insurance status of these patients was 26.2% uninsured, 39.3% Medicaid, 18.9% Medicare, 9% commercial, and the remainder workers compensation, liability or prisoner care. Wait time significantly correlated with length of stay.

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Novel 3D-printed device has potential to treat spinal cord injuries

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ccording to a press release, researchers at the University of Minnesota have developed a 3D-printed system for treating spinal cord injuries. The press release reports that a 3D printer is used to print a silicone “guide” and subsequently used to print neuronal stem cells onto this guide. The guide is then surgically implanted into a patient with a spinal cord injury to act as a bridge between the stem cells and the area of injury; the aim is for the stem cells to help alleviate pain and restore some functions such as control of the bladder. The press release notes that the neuronal stem cells were created with a unique process, developed at the University of Minnesota over the past two years, in which any type of stem cell (i.e. a blood cell) can be reprogrammed into the required stem cell (i.e. neuronal).

Daeha Joung (University of Minnesota, Minneapolis, USA) and colleagues have published their research into the 3D-printed system in Advanced Functional Materials. Michael Alpine (University of Minnesota, Minneapolis, USA), one of the authors of the paper, says: “This is the first time anyone has been able to directly 3D print neuronal

MedTech see page 10).

Furthermore, a first-in-human study published in Cell Stem Cell provided support for the use of transplanted NSI-566. It showed motor and sensory function improvement in three of four patients implanted with NSI-566—a spinal cord derived neural stem cell that is being evaluated for both spinal cord injuries and for ischaemic stroke.

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Drug Administration (FDA) approval.

It has a PEEKplus nanotextured surface that is designed to promote osteoblast function and, thus grow bone and promote fusion. At present, it is the first and only PEEK device to have a nanotextured surface.

The second and third devices— Fortilink-TS and –L IBF systems—are from RTI Surgical. Instead of PEEK, these devices are comprised of TETRAfuse 3D technology (3Dprinted polymer) and incorporate a “nano-rough” Fortilink-TS (RTI Surgical) surface. RTI Surgical announced the commercial launch of these devices, which are designed for lumbar interbody fusion procedures, in June this year.

stem cells derived from adult human cells on a 3Dprinted guide and have the cells differentiate into active nerve cells in the lab.”

The 3D-printed system is just one of several novel approaches currently Nanotechnology being evaluated for now being used the treatment of spinal in interbody fusion cord injuries. For devices example, a rat study 3D-printed device (credit: Three different interbody published in The JourUniversity of Minnesota) fusion devices that use nal of Neuroscience nanotechnology are now indicates that the use of a hydrogel available. The first is a polyetheretherrestores independent breathing control ketone (PEEK) spinal interbody fusion after spinal cord injury. The hydrogel device from Vallum Corporation, is designed to bind to the neuro-stimuwhich recently received US Food and lating agent brain-derived neurotrophic factor and release this nerve-repair protein at the site of the injury.

BIBA Briefings is a new platform that provides in-depth analysis of the latest Another study, this time published market intelligence from BIBA MedTech, which provides consulting and market in Brain, showed that novel immuneanalysis services to medical professionals and organisations in the medical evasive gene therapy restored skilled device industry in Europe and North America. The platform also reviews data grasping function in paralysed rats. The and news. therapy uses the enzyme chondroitinase The aim of each report is to give an overview of the key information affecting the ABC (ChABC), which has previously medical device industry, enabling those working in the industry to keep abreast been shown to reverse neurite growth of the latest developments and make knowledgeable decisions. arrest in vivo, enhance central nervous system axonal regeneration and plasticFor more information about BIBA Briefings or BIBA MedTech ity, and promote functional recovery afPlease contact Elizabeth Sutherst: elizabeth@bibamedical.com ter spinal cord injury (for a full report,

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Industry news

Europe braces for harder times in medical device innovation while US FDA eases regulations Countries in the European Union have long been the first to receive new innovations in medical technology, as the EU’s Medical Device Directive (MDD) provided quicker routes to implementation of new devices than its equivalent in the USA, the Food and Drug Administration (FDA). However, on both sides of the Atlantic, the regulatory pace is likely to change over the next few years—in opposite directions.

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he EU is moving to replace the MDD with the Medical Devices Regulation (MDR): a more extensive regulatory document, introducing significant revisions to quality and safety standards and the range of regulated devices. The MDR was initiated in May 2017, and a three-year transition period applies. Current MDD certificates remain valid, but cannot be renewed, meaning that from 26 May 2020 onwards, all medical devices brought to market in the EU and Switzerland must conform to the MDR. While increasing demands on the standard of clinical data and safety profiles of new technology, medical device innovation in the EU is likely to see reduced speeds on the road to the CE mark.

Meanwhile, the US FDA has published its strategic priorities for the MDD-MDR transition period of 2018–2020, outlining an aim to “reduce the time and cost of generating clinical evidence, typically the most expensive and lengthy regulatory requirement for marketplace entry.” The FDA states it has adapted their policies and procedures to “facilitate and streamline the development and approval” of clinical trials in the USA, and redistributing the data collection requirements preand post-market. “By striking the right balance between pre-market and post-market data collection, we can help assure we get the right data at the right time, thereby creating incentives for timely patient access to high-

quality, safe and effective technologies to improve their health and quality of life.”

Speaking on the subject in the Innovators Showcase session at the Charing Cross Symposium (CX; 24–27 April, London, UK), Veryan CEO Chas Taylor noted that the FDA’s strategic direction is “more open and approachable,” and while it does not change the burden of proof, it “makes the system easier to navigate.” The EU MDR on the other hand, “will increase barriers to entry in Europe” with new regulation, Taylor said.

The panellists of the session, Gido Karges (Wangs, Switzerland) and Jeffrey Jump (Most-sur-Rolle, Switzerland) similarly feared that the pace of innovation in Europe will be diminished, with Jump stating that “the golden age of innovation in Europe is coming to an end.” Jump suggested “CE mark lead approval time will at least double (6–12 months)”, and claimed “the number of innovative medical devices receiving CE mark will drop down by an estimated 30%.”

Karges explained the ramifications: “Expenditures associated with MDR compliance are enormous. Due to these costs, device developers will need to make choices about which areas of their business to remediate first.

Some may decide the costs of remediation exceed the business opportunity, choosing to sell or close down certain product lines. As manufacturers decide to dis-

Industry News Cerapedics announces closing of US$22 million financing

i-FACTOR bone graft

Cerapedics has announced that the company completed a US$22 million financing led by KCK Group, a family investment fund that focuses on innovative medical technologies that meet significant clinical needs.

This equity funding will accelerate the commercial release of i-FACTOR peptide enhanced bone graft and support the execution of a second Level I investigational device exemption (IDE) human clinical study, the company states.

Glen A Kashuba, chief executive officer of Cerapedics, comments, “We understand the value of Level I human clinical data and are committed to investing and expanding our indications. We are fortunate to be supported by KCK Group, a partner that shares in the long-term vision that differentiated products that provide safety, efficacy and economic value, supported by human clinical results, will ultimately provide the highest value

to surgeons and their patients.”

Cerapedics also announced that three new members have been appointed to the company’s board of directors including Valeska Schroeder, managing director of the medical technologies division at KCK Group, Greg Garfield, senior managing director and head of the medical technologies division at KCK Group, and Nael Karim Kassar, investment partner at KCK Group.

“Cerapedics is well-positioned for strong growth with Level I data establishing i-FACTOR’s superiority and with a dedicated team that has deep experience in orthobiologics and spinal fusion,” says Schroeder. “This financing will allow Cerapedics to further invest to increase physician access to i-FACTOR and to build clinical evidence for new indications.” i FACTOR peptide enhanced bone graft is based on proprietary biomimetic small peptide (P-15) technology that has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disc disease. This unique drug-device technology enhances the body’s natural bone healing process through cellular activity that is directional and predictable.

continue legacy products, suppliers go out of business, dragging other manufacturers who bought from them behind. German and Swiss health authorities predict the extinction of 30% of all medical device manufacturers.

They also expect that 50% of all medical devices will be discontinued or fail to meet the requirements. Patients might be at risk—it is a very grim outlook.”

In contrast, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is collaborating with the US FDA to allow “globalisation” of approval studies, Taylor highlighted, in an initiative called “harmonisation by doing.” The FDA state that the initiative will see them agreeing with the PMDA, academia and industry on internationally developed standards for global clinical trials related to cardiovascular devices, addressing “regulatory barriers that may delay timely medical device approvals in both countries.”

Jump summarised, “The FDA and other competent authorities have released new regulations and guidelines in order to decrease the burden of getting market access for innovative devices.”

“Europe is now heading in the opposite direction, particularly for innovative products. Due to the uncertainty of MDR implementation and interpretation, increased cost of compliance, fragmented distribution and divergent reimbursement policies, the 40-year old model of ‘go to Europe first’ will be challenged. Europe may have to wait for innovative medical devices to be proven safe and effective in other markets before European patients will have access to improved technologies. I believe innovators will follow the path of least resistance and vote with their feet.”

Cerapedics received premarket approval (PMA) from the US Food & Drug Administration (FDA) for the use of i-FACTOR peptide enhanced bone graft in anterior cervical discectomy and fusion (ACDF) procedures, becoming the first PMA-approved bone graft with this indication. The company has also initiated an IDE clinical trial in transforaminal lumbar interbody fusion (TLIF) surgery.

CoreLink acquires medical device company Expanding Orthopedics

CoreLink, a manufacturer of spinal implant systems, acquired Israel-based Expanding Orthopedics, a privately held medical device developer.

Along with the FDA cleared expanding and articulating FLXfit and FLXfit 15 titanium TLIF interbody systems, CoreLink has also acquired a broad array of patents and in-development products addressing the expandable interbody and spinal fusion market.

“This acquisition provides two key benefits for CoreLink and its customers: a very compelling offering in the growing expandable interbody product category and a portfolio of innovative intellectual property from which we can advance spine care,” CoreLink CEO Jay Bartling comments.

FLXfit 15 is a titanium transforaminal lumbar interbody fusion (TLIF) device compatible with minimally invasive surgery. Once in the disc space, it articulates to aid placement along the anterior aspect of the apophyseal ring,

providing up to 40mm of footprint length along this critical anterior column. The anterior height of the device can be continuously expanded an additional 4mm to provide up to 15° of lordosis.

A company press release states that CoreLink will provide enhanced support for existing users of both the FLXfit and FLXfit 15 systems, while utilising its vertical integration to quickly incorporate system upgrades for a full commercial relaunch in the third quarter of this financial year.

TriStar Centennial Medical Center acquires the first Levó head positioning system

Levó head positioning system

TriStar Centennial Medical Center (Nashville, USA) is the first healthcare system to incorporate the Levó head positioning system (Mizuho OSI) into their operating room. Mizuho OSI state claim that the system confers better control and safety of a patient’s head position while spinal surgery is performed, reducing the time a patient needs to spend in the operating theatre.

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Industry news de-identified at the point of entry and no personal information reaches NASS or its data vendor, Ortech Systems. Each participant owns its own data and NASS owns the aggregate, de-identified data.

“One great thing about this registry design is that it requires the active participation of the most important people in health care, our patients,” Resnick comments. “Each time a patient enters their data, they will be able to see how they are progressing over time. There will also be links to helpful education information for them to use.”

Industry News A company press release states that “TriStar Centennial strives to support its world-class surgeons through innovation that makes performing spine surgery easier.” Traditional head positioning equipment uses multiple pins and supports to keep a patient’s head and neck in a stabilised position. When a patient requires repositioning during a procedure, the process of readjusting typically involves using cumbersome mechanisms, often requiring the surgeon and an additional person to manoeuvre the head and spine at the same time. Without the ability to fully control a patient’s spine and head, the patient is at a higher risk for injury. The Levó minimises the complications of head positioning by providing surgeons with a more streamlined level of control during spine procedures using “innovative” technology.

“By incorporating the Levó into their operating room, TriStar Centennial can improve patient care through less time spent in surgery,” says Brett Babat (Nashville Neurosurgery Associates; TriStar Centennial Medical Center, Nashville, USA). “During spine procedures, having precise control of a patient’s head and neck is absolutely critical, which isn’t always possible with traditional head positioning equipment.

With the Levó, surgeons no longer have to rely on another team member to help with repositioning—by restricting motion to one movement plane, miniscule yet critical adjustments are easily achieved.”

NASS launches multidisciplinary Spine Registry to “Collect, measure, care”

US spine care providers have a brand new tool to measure and improve patient care: a diagnosis-based clinical data registry that tracks patient care and outcomes.

Launched by the North American Spine Society (NASS), this web-based platform will allow health care providers to collect and analyse their spine care data and compare it to the de-identified data in the entire registry. Because it is diagnosisspecific, not procedure-specific, the NASS Spine Registry will enhance understanding of spine care treatments, their outcomes, and examine the natural history of spine disorders.

“In order to prove or disprove the effectiveness of spine treatments, the spine field needs to gather evidence,” says Zoher Ghogawala (Lahey Hospital & Medical Center, Burlington, USA), NASS research council director. “With its national reach and comprehensive nature, the NASS Spine Registry will help the spine care field make substantial progress on improving quality, developing best practices, and closing the gaps in medical evidence for spine care.”

From the initial idea to the implementation of a pilot program, the NASS Spine Registry was developed over the past eight years. NASS has

NuVasive and Siemens Healthcare to partner on new spine imaging and navigation technology

NuVasive and Siemens Healthineers have announced a strategic partnership, which is to focus on “technology development, marketing and commercial activities to advance clinical outcomes in minimally invasive spine surgery”, according to the two companies.

NuVasive is a spine health technology company, with a focus on products for minimally invasive surgery. NuVasive currently has a 2,400-person workforce, and serves surgeons and hospitals in more than 40 countries. Siemens Healthineers offers surgeons a broad portfolio of Zoher Ghogawala imaging systems including 3D imaging for complex spine cases.

In their Spine Precision Partnership, made every effort to minimise potential the companies will join forces in barriers to participation, including cost, advancing their proprietary technologies privacy concerns, administrative burden, with the objective of creating solutions and institutional review board (IRB) participation, a press release states.

“The really exciting and unique thing about the NASS registry is that it is multidisciplinary,” says Daniel Resnick (University of Wisconsin, Madison, USA), NASS president and chair of the NASS Registry Committee. “Despite the fact that more than 90% of spine care is managed without surgery, most existing registries are focused around surgical specialties or procedures. Thanks to the comprehensive nature of this registry, we will be able to see what care approaches are actually helping patients restore their function and reduce pain.”

Any spinal care provider, including physicians or allied health professionals, regardless of specialty, setting, or medical/ surgical orientation, can participate in the NASS Registry. There is no software to purchase, no dedicated coordinator required, and participants do not need to be NASS members. For the first participant per practice site, registry is US$3,250. NASS states that registry participation is therefore “affordable for all practice types and sizes―from the largest health systems to solo practitioners.” Each subsequent participant per practice is $300 for a year.

Registry participants will receive confidential feedback on their patient care and will have access to reports with benchmarking against their peers through the de-identified, aggregate data. They will be able to download real-time reports at their convenience to see results. The data collected include demographics, diagnosis, treatment, complications, and patient-reported outcomes. The data are Dan Resnick

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which improve operating room workflow efficiency and provide increased precision in the delivery of minimally disruptive spine surgery technologies, a press release states. The first step in the Spine Precision Partnership will be to integrate NuVasive’s Pulse surgical automation platform with Siemens Healthineers’ Cios Spin cutting-edge mobile 3D imaging for intra-operative quality assurance.

“Currently, a number of hospitals and healthcare systems treat patients undergoing spine surgery through often cost-intensive, intra-operative CT scans with a general navigation system with limited utilisation in spine surgery cases. The combination of NuVasive’s Pulse system and the Siemens Healthineers’ next-generation advanced imaging technology provides a compelling offering for hospitals and surgeons who require a scalable, cost efficient technology that maximises operating room workflow efficiency and significantly improves visualisation for spine surgery,” says Gregory T Lucier, chairman and chief executive officer of NuVasive.

“Increased workflow efficiency, better image quality, as well as predictable and reproducible results, will transform care delivery and set a new standard in spine surgery,” comments Peter Seitz, head of Surgery at Siemens Healthineers.

The Cios Spin is not commercially available in the USA yet, and its FDA 510(k) clearance is pending.

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Clinical news

Clinical News Amgen receives positive CHMP opinion to expand use of Prolia (denosumab) to patients with glucocorticoidinduced osteoporosis

The committee for medicinal products for human use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion in the marketing authorisation of Prolia (denosumab) for the treatment of bone loss associated with longterm systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Glucocorticoid medications, which are

Prolia

used to treat many inflammatory conditions such as chronic obstructive pulmonary disorder (COPD), asthma, multiple sclerosis and rheumatoid arthritis, can cause significant side effects, including bone loss.

The CHMP recommendation is supported by a Phase 3 randomised, double-blind, double-dummy, activecontrolled study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment. The study included two patient groups: those on sustained glucocorticoid therapy, and those newly initiating glucocorticoid therapy. The study met the primary endpoint (percent change from baseline in lumbar spine bone mass density at 12 months, assessing noninferiority) and all secondary endpoints (the percent changes from baseline in lumbar spine and total hip bone mass density at 12 and 24 months, assessing superiority).

Study results showed that, in patients on sustained glucocorticoid therapy, Prolia treatment led to greater gains in bone mass density, compared with risedronate, both at the lumbar spine (4.4% vs. 2.3%, respectively) and total hip (2.1% vs. 0.6%, respectively). Similarly, in patients newly initiating glucocorticoid therapy, Prolia treatment led to greater increases in bone mass density, compared with risedronate, both at the lumbar spine (3.8% vs. 0.8%, respectively) and total hip (1.7% vs. 0.2%, respectively).

Adverse events and serious adverse events were similar between treatment groups and consistent with the known safety profile of Prolia. No serious adverse events were reported with a subject incidence of 2% or greater in either treatment group.

The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

The US Food and Drug Administration

is currently reviewing a supplemental Biologics License Application for this expanded indication.

CIMZIA effective in treating axial spondyloarthritis patients

CIMZIA (certolizumab pegol) is the first therapy to demonstrate positive results in a 52-week, placebo controlled non-radiographic axial spondyloarthritis study. The positive topline results from C-AXSPAND, a Phase 3 multicentre, randomised, double-blind, parallel-group placebo controlled study to investigate the efficacy of CMIZIA on the signs and symptoms of active non-radiographic axial spondyloarthritis, underscore the potential of the therapy.

The study met the primary objective of achieving a major improvement: 47.2% of CIMZIA-treated patients demonstrated a two-point improvement in ankylosing spondylitis disease activity score (ASDASMI) at week 52, compared to just 7% of placebo patients. The study also met assessment of spondyloarthritis international society 40% (ASAS40) response at week 12, a key secondary objective.

CIMZIA

The results provide concrete evidence for the high burden of the disease and limitations of current standard of care to provide adequate disease control, a UCB press release states. The company states that it looks forward to quickly submitting the data to the US food and drug administration (FDA), as there are currently no approved biologic treatment options in the US for nonradiographic axial spondyloarthritis.

“People living with non-radiographic axial spondyloarthritis frequently face delayed or incorrect diagnosis, and currently, in the USA, there are no FDA approved options to treat this condition. The C-AXSPAND study results provide important insights into the potential of CIMZIA as an effective and durable treatment option for these patients. Additionally, the study is unique in that it used ASDAS-MI, a rigorous response threshold, and assessed the long-term efficacy of CIMZIA in a one-year, placebo-controlled trial.” says Atul Deodhar (Oregon Health & Science University, Portland, USA), lead investigator for the study.

Pivotal clinical trial demonstrates superiority of anular closure compared to standard lumbar discectomy The use of a bone-anchored anular closure device following discectomy is superior to treating high-risk patients with

discectomy alone, a two-year study recently published in The Spine Journal reports. The landmark, randomised superiority clinical trial investigated the Barricaid anular closure device (Intrinsic Therapeutics) in comparison to today’s gold standard of discectomy without anular closure for patients at higher risk of recurrent lumbar disc herniation.

The clinical trial included 554 randomised patients. Its purpose was to determine whether a microdiscectomy with a boneanchored anular closure device resulted in lower reherniation and reoperation rates and increased overall patient clinical success, when compared to traditional lumbar discectomy without defect closure.

The group treated with Barricaid had significantly lower rates of reherniation (12% vs. 25%, p<0.001), reoperations to address recurrent herniation (5% vs. 13%, p=0.001), and index-level reoperations (9% vs. 16%, p=0.01).

“In order to fully comprehend the benefit of treating these patients with an implant, it is important to realise that patients who are reoperated generally do not reach the same pain and functional improvement of patients who did not have additional surgery. The odds of not returning to work were nearly three times higher after a revision surgery.

Barricaid cuts the rate of reoperations in half at two years, preventing chronic disability and improving quality of life,” explains Matthew McGirt (adjunct research associate professor, University of North Carolina, USA), who was not involved in the study.

In addition, the rates of serious adverse events related to either the implant and/or procedure was 7% in the Barricaid group and 17% in the control group (P=0.001), indicating that use of the Barricaid lowers the incidence of hospital readmissions.

“These study results shine a spotlight on the fact that if we add a device to a procedure that doesn’t otherwise have one, the treatment cohort experiences fewer related hospital readmissions, with a 40% reduction at two years. According to current follow-up data of up to five years this differential is maintained,” says Claudius Thomé (Department of Neurosurgery, University of Innsbruck, Austria), one of the principal investigators of this trial.

Barricaid annular closure device

“Moreover, if a reoperation needs to be considered in a patient later on, the same revision strategies are possible with this implant as after microdiscectomy alone.”

Within the discectomy population, patients with large defects in their anulus following lumbar discectomy are at high risk of symptomatic recurrence and reoperation.

According to literature, 30–40% of all discectomy patients fall into this group. With almost 500,000 discectomies performed annually in the USA alone, this poses a significant problem not only for the patients affected, but also for society as a whole.

The company currently markets and sells the Barricaid in Europe, Australia, Mexico, the Middle East and selected countries in other regions around the world. In the USA, Intrinsic Therapeutics is seeking regulatory approval of the Barricaid Anular Closure device.

First porous PEEK spinal implant clinical study validates NuVasive advanced materials science technology in treating degenerative cervical disc disease

Porous polyetheretherketone (PEEK) technology (NuVasive) is a clinically viable alternative for improving osseointegration and fusion rates of interbody implants to treat degenerative cervical disc disease, a recent paper in the Journal of Spine & Neurosurgery reports.

In the study, 50 patients (31 women and 19 men; average age 60) with degenerative cervical disc disease underwent anterior cervical discectomy and fusion using a Cohere cervical interbody fusion device (NuVasive)—with 100% of participants experiencing positive results.

Cohere provides a unique threedimensional porous PEEK architecture to help elicit and encourage bone ingrowth without compromising implant strength, a press release states. The porous PEEK technology has been validated by ten years of scientific research, and has been incorporated into NuVasive’s portfolio since the company acquired Vertera Spine in September 2017.

“This interbody fusion device with porous PEEK surface technology provided improved osseointegration and supported spinal fusion in single level and multi-level cervical fusions,” says J Kenneth Burkus (Hughston Clinic, Columbus, USA).

“Twelve-month clinical outcomes have demonstrated the efficacy and stability of the Cohere porous PEEK interbody device and shown that it is a clinically viable implant alternative for achieving successful clinical and radiological outcomes in cervical spine fusion surgery, particularly in multi-level or revision surgeries where fusion rates are lower.”

During the course of the clinical study, there were 11 one-level, 23 two-level and 16 three-level fusions between C3 and C7.

Patients came from all walks of life and with various comorbidities. Thirteen of them had previously had an unsuccessful anterior cervical fusion procedure. Notably, all patients who had revision surgery with Cohere achieved fusion six months after the surgery.

At 12 months post-operative anterior cervical discectomy and fusion surgery, all 50 patients demonstrated improved motion, decreased neck pain and average disc height increased by more than 4 mm. In addition, each of them showed radiographic fusion.

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Product news

Product News K2M receives FDA clearance for Cayman United Plate System Following the completion of its first surgical cases, K2M has received Food and Drug Administration (FDA) 510(k) clearance and a CE mark for its Cayman United Plate System.

The Cayman United Plate System is designed for rigid fixation to K2M’s Cascadia Lateral 3D Interbody System, which features Lamellar 3D Titanium Technology. It is the only 3D-printed cage with modular fixation capabilities, a company press release informs.

Cayman United’s single level, oneand two-hole plate configurations match all Cascadia Lateral 3D height and lordosis options, allowing surgeons to customise the construct using a lateral approach. Single-level plate sizes are designed to minimise retraction required for placement. An assembly alignment feature keys into the Cascadia implants to resist rotation.

K2M’s Lamellar 3D Titanium Technology uses a 3D-printing method to produce the Cascadia implants The Cayman from a titanium Plate System

powder. The company uses a highenergy laser beam to incorporate a rough surface architecture that preclinical data have associated with the stimulation of bone growth.

“The Cayman United Plate System, which firmly fixates to K2M’s Cascadia Lateral 3D implants, is a notable advancement,” says Robert Lee, a spine surgeon at Royal National Orthopaedic Hospital NHS Trust (Stanmore, UK).

“Its streamlined technique and versatile insertion options provide an elegant solution for my minimally invasive lateral cases, while also utilising a 3D-printed device to encourage bony integration throughout the implant.”

Bone cement solution indicated for treating sacral fractures granted FDA approval

The US Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon HV-R bone cement (Medtronic) for fixation of pathological fractures of the sacral vertebral body (or ala) using sacral vertebroplasty or sacroplasty.

Medtronic state that this broadens the company’s commitment to treat fragility fractures beyond vertebral compression fractures caused by osteoporosis, cancer or benign lesions. With this expanded indication for Kyphon HV-R

bone cement, clinicians have more options for treating patients with sacral insufficiency fractures.

“Patients who experience sacral insufficiency fractures often suffer a substantial degree of pain and disability,” says Thomas Andreshak (Mercy St Vincent Medical Center and St Luke’s Hospital, Maumee, USA).

“This new indication for Kyphon HV-R cement, along with Kyphon Xpede bone cement will provide another excellent option to help these patients.”

Sacral insufficiency fractures are a common cause of debilitating back pain. Sacral insufficiency fractures mimic the symptoms of lumbar spine pathology. Studies show more than two-thirds of patients diagnosed with sacral insufficiency fractures are not able to associate their pain with a traumatic event. As a result, physicians often prescribe conservative treatment, including physical therapy and prolonged bed rest. These patients report 20¬¬¬¬¬¬–45-day inpatient stays at the hospital, and prescription narcotic use associated with pain from untreated sacral insufficiency fractures, which are significant expenses to the healthcare system and result in lost productivity. Patients treated with bed rest are at increased risk of pulmonary embolism and deep vein thrombosis, as well as further muscle atrophy and bone loss.

“In my practice, patients with sacral insufficiency fractures treated with sacroplasty experience immediate pain relief that allows them to resume daily

icotec AG receives FDA clearance to market BlackArmor® Carbon/PEEK interbody cages

T

he latest line of icotec interbody cages, designed to optimise bony integration and post-operative visualisation, has received US Food and Drug Administration (FDA) 510(k) clearance. The clearance includes cages for a variety of surgical approaches, such as cervical fusion procedures like anterior cervical discectomy and fusion (ACDF) procedures, as well as lumbar procedures like posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF).

All the interbody cages have, at their core, icotec’s unique BlackArmor® Carbon/PEEK material, which consists of continuous carbon fibres combined with PEEK, and are produced using icotec’s Injection Moulding CFM (Composite Flow Moulding) manufacturing technology. This process allows reproducible product quality with the consistent orientation of the continuous carbon fibres, resulting in unparalleled strength and mechanical durability while providing excellent imaging quality and a modulus of elasticity close to half that of titanium. All cages are circumferentially (360°) coated with a rough Ti-iT® titanium coating, which is applied using a VPS (Vacuum Plasma Spray)

technologies, BlackArmor material and Ti-iT coating, allows us to provide implants that can truly make a difference for patients and their clinical outcome.

With the combination of the two core icotec interbody cages technologies in our interbody cages, we see excellent fusion results without procedure. The Ti-iT commercially pure compromising the post-operative image titanium coating from icotec enables quality”, says Roger Stadler, CEO of bony on-growth to the implant. Bone icotec AG (Switzerland). “Our focus tissue attaches and integrates safely into has been on developing implants with the surface of the implant due to the comparable osseointegration and biorough structure. mechanical strength to titanium while icotec is the only company manufacadding unparalleled postoperative Xturing spinal implants made of non-meray, CT and MR imaging for any spinal tallic, radiolucent BlackArmor Carbon/ pathology, including but not limited to PEEK composite material. Implants degenerative disc conditions and spinal made of BlackArmor are biocompatible tumour.” and have been successfully implanted The latest version of icotec’s cage line for over 15 years. Their X-ray transhas been available in countries requiring lucency makes a significant difference CE Mark since 2011 and over 8,500 during intra- or postoperative assessinterbody cages have been successfully ments of the site of care and for spinal implanted to date. icotec cages will be fusion. Especially in patients with spinal widely available in the USA starting in tumours, optimal delineation of the August 2018. tumour from healthy tissue can facilitate icotec will showcase its full line of radiotherapy planning, optimise radiocages at this year’s NASS convention surgery treatment and allow immedifrom September 26–29 at the Los Angeate and precise monitoring of possible les Convention Center (South Building, relapses (tumour recurrence).

Los Angeles, California, USA).

“Our ability to combine two unique This feature is sponsored by icotec.

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activity and/or physical therapy without suffering from pain and physical limitations,” Labib F Haddad (West Country Radiological Group, St Louis, USA) comments. “The procedure of sacroplasty with HV-R cement is a minimally-invasive procedure usually performed in an outpatient setting.”

Next generation Reline system launches

The next evolution of the Reline system (NuVasive) has just launched: the Reline MAS Midline (RMM). The company description says this system provides “procedural versatility in a compact midline construct”.

RMM incorporates low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce adjacent segment transition syndrome.

The system is designed to provide a minimally invasive approach to bilateral decompression under complete visualisation, interbody fusion and stabilisation with pedicle screws.

Delivering screw modularity, RMM allows for greater procedural flexibility while enhancing visibility and access.

“RMM posterior fixation represents the most advanced midline cortical pedicle screw system on the market,” says minimally invasive spine surgeon Nitin Khanna (Clinical Faculty of Orthopaedic Surgery, Indiana University School of Medicine; partner, Orthopedic Specialists of Northwest Indiana, USA). “The introduction of modular, low-profile tulip heads was designed to address concerns with adjacent segment facet joint impingement. This system furthers NuVasive’s midline portfolio as bestin-class.”

According to NuVasive, the RMM solution utilises adaptable, streamlined instruments to support both cortical and standard trajectory techniques. The midline approach is simplified with the integration of access, interbody and fixation, while modular screw assembly is confirmed with visual and tactile feedback.

During the company’s first-quarter earnings call in May, NuVasive CEO Greg Lucier stated that NuVasive plans to launch more than a dozen new products this year spanning from implant systems to the introduction of its Surgical Intelligence platform, in addition to next-generation rods for early-onset scoliosis.

NuVasive Reline system

28

Sept

Product News FDA clears first nanotechnology PEEK devices for spinal intervertebral fusion

The US Food and Drug Administration (FDA) has granted approval to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface (Vallum Corporation). The PEEKplus nanotextured surface is the first and only FDA-cleared nanotextured surface on a PEEK interbody device, and is created by Vallum’s proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology.

Nano-scale concavities of 20–50 nanometres are created by the impact

of argon atoms across the entire existing microsurface of the PEEK to create the nanotexture of PEEKplus.

Importantly, nanotexturing below 100 nanometres has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion.

PEEKplus is not a coating, it is not porous, and no chemicals are infused into the PEEK, a press release explains.

“Technological advances to improve the performance of implantable medical devices are taking many forms,” says Elazer R Edelman (Boston, USA), who provided the earliest advice and encouragement

to Vallum’s management team. “I believe one of the most important of those technological advances is surface modification at the nanoscale, and Vallum’s FDA clearance is a significant step down that very promising path.”

While this FDA clearance is specific to Vallum, its nanotexturing technology can be inexpensively applied to any fully manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties.

Life Spine announces line extension of PROLINK titanium stand-alone cervical spacer system

The US Food and Drug Administration (FDA) has given 510(k) clearance to the PRO-LINK titanium stand-alone cervical spacer system (Life Spine) for

spinal fusions.

PRO-LINK feature’s Life Spine’s OSSEO-LOC surface treatment, and has experienced great success since inception, a press release states. The company states that it is pleased to announce the 510(k) clearance, as it adds additional footprint sizes that enhance the ability to treat a wider variety of patient anatomies.

“The expanded footprint offering of PRO-LINK Titanium helps me address a larger patient population by accommodating smaller and female patient anatomy,” says Randall Dryer (Central Texas Spine Institute, Austin, USA).

The FDA granted 510(k) marketing clearance to the company’s PROLINK Titanium stand-alone cervical spacer system in September 2016, with the device’s use in initial clinical cases being announced later that same autumn.

Calendar of events 26–29 September

21–25 October

03–05 December

Brussels, Belgium

Dubai, UAE

W www.eans2018.com

W www.arabspinediploma.org

26–28 October

05 December

Cundinamarca, Columbia

Scottsdale, USA

W www.spine.org/education

W www.csrs.org

09–10 November

06–07 December

Burr Ridge, USA

Dubai, UAE

W www.spine.org/education

W www.arabspinediploma.org

16–17 November

06–08 December

Brussels, Belgium

Wiesbaden, Germany

W www.spinesymposium.com

W www.dwg.org

W www.srs.org

17–19 November

06–08 December

19–20 October

Jeddah, Saudi Arabia

Cervical Spine Research Society 46th Annual Meeting

W www.saudispine.org

Scottsdale, USA

North American Spine Society (NASS) Annual Meeting Los Angeles, USA W www.spine.org/education

05–07 October

ISSICON 2018 International Spinal Cord Injury Care In Emerging India Chennai, India W www.issicon2018.com

06–10 October

Congress of Neurological Surgeons Houston, USA W www.cns.org

10–13 October

Scoliosis Research Society (SRS) 53rd Annual Meeting & Course Bologna, Italy

EANS 2018

Fundamentals of Spine Surgery: A Residents and Fellows Surgical Course

ArabSpine Module 1 and 3

NASS SILACO Advanced Lumbar Spinal Injection Techniques

Contemporary Management of Spinal Tumours

25th Brussels International Spine Symposium (BISS)

2nd Saudi Spine Society Annual Meeting

Cervical Spine Research Society (CSRS) 23rd Instructional Course

Emirates Neurosurgery Annual Conference

13th German Spine Congress of the DWG

W: www.csrs.org

Burr Ridge, USA W www.spine.org/education

Issue

March

16 38

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Issue

18 48

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