Spinal News International Issue 52 – September 2019

September 2019 | Issue 52

Worldwide burnout survey “highlights the need for better interventional programmes”

Results of a worldwide survey indicate that the overall prevalence of burnout among spine surgeons is 30.6%. They suggest that factors linked with higher likelihood of burnout include working in North America, being in training as a fellow, and working more than 60 hours per week. In addition, professional burnout was associated with depression, anxiety, pain, and difficulty with usual activities. This survey was conducted by Alisson R Teles (McGill University, Montreal, Canada) and colleagues, and won the Best Paper Award at the 2019 Global Spine Congress (GSC; 15–18 May, Toronto, Canada).

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Intravenous ketorolac substantially reduces opioid use following lumbar spinal fusion Early results of a double-blind, randomised, placebo-controlled trial show that intravenous ketorolac leads to a “substantial reduction” in opioid use and improved pain control compared to placebo and intravenous acetaminophen.

In addition, the investigators note a trend toward decreased length of stay with intravenous ketorolac, and no increase in rates of haematoma, drain output, transfusions or serum creatinine.

L–R: GSC regional co-chair Asdrubal Falavigna, Alisson Teles, and GSC chair Jeffrey Wang

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n a Special Report from 2011 on suicidal ideation among American surgeons, Tait D Shanafelt and colleagues conveyed that the suicide rate was three times higher among American surgeons than in the general population, and that burnout and depression were independently associated with suicide ideation after controlling for personal and professional characteristics. The authors noted that one in 16 surgeons had suicide ideation in the last year, while only 26% sought psychiatric help.

The authors of the present study noted that there is no information on the prevalence of burnout among spine surgeons and factors associated with this condition.

“This directly limits health policy interventions that could improve the well-being of both patients and spine surgeons,” they comment.

An electronic survey was used to assess general characteristics, the Maslach burnout inventory of emotional fatigue, depersonalisation, and personal Continued on page 4

FIRST AUTHOR SRAVISHT IYER (Hospital for Special Surgery, New York, USA) recently presented the study at the 26th International Meeting on Advanced Spine Techniques (IMAST; 17–20 July, Amsterdam, The Netherlands), at which it was announced as the winner of the Whitecloud Award for Best Clinical Paper. The research was supported by a North American Spine Society Research Grant.

The investigators found that intravenous ketorolac reduces opioid use after spinal fusion by over 40% compared to placebo, and over 30% compared to intravenous acetaminophen, as well as improved pain control on postoperative day one after lumbar spinal fusion. Furthermore, alongside a trend toward decreased length of stay, they did not notice any Continued Continued onon page page 004

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September 2019 | Issue 52

Physician burnout

Worldwide burnout survey “highlights the need for better interventional programmes” Continued from page 1

fulfilment, and the EQ-5D was used to assess quality of life.

A total of 818 surgeons from 87 countries were given the survey, and the response rate was 13.2%.

The majority of the cohort were male (93.4%) and the average age of the participants was 43.45. Just over three-quarters of the sample were married (76.3%) and the most common number of children they had was two (36.8%).

The overall prevalence of professional burnout was 30.6%. Eighteen per cent experienced high emotional fatigue and 21% experienced high depersonalisation.

The prevalence of these two factors was highest in North America, both at just over 30%. The prevalence of low personal fulfilment was 23% in total, with the highest rate for this category being in Europe, again at just over 30%.

According to the authors, independent factors associated with burnout among spine surgeons include working in North America, being in training as a fellow, and working more than 60 hours per week. In terms of the EQ5D scores, 33.6% reported pain, 28.4% reported anxiety or depression, and 10.8% difficulty with usual activities.

The majority of the surgeons who took the survey specialised in orthopaedics (62.2%), and just over half worked between 40 and 60 hours per week (54.4%).

Just under half of the group (45.2%) had more than 10 years of experience. Participation from fellows, the group with the shortest duration of practice, was the lowest, at 13.7%. Most survey respondents performed both adult and paediatric surgery (53.6%); the next most prevalent cohort were those who performed spinal

Fellowship programme directors should [...] take measures to minimise and mitigate trainee burnout.”

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surgery on adults only (44.3%). The remaining 2.1% performed surgery on paediatric cases only.

Teles acknowledges some limitations of the survey, including the low response rate, a possible nonresponse bias, and the fact that the burnout rate was measured at a single point in time. He recognises that “variations in the level of burnout may occur in individuals over time”. He notes that the short form of the survey had both a positive and negative impact on the results. While the format yielded improvement in the response rate among AOSpine members, it provided only a limited amount of data.

Overall, Teles and colleagues conclude: “We must recognise that burnout is an important problem affecting the lives of spine surgeons worldwide. This survey highlights the need for the development of interventional programmes to better identify, prevent, and manage this condition in this population.”

Given the high prevalence of burnout among the fellows included in this survey—the highest of four groups based on duration of practice—they comment: “Fellowship programme directors should be aware of this and take measures to minimise and mitigate trainee burnout.”

Capping medical residency hours does not hamper new doctors’ quality of training

When new rules capped training hours for medical residents at 80 hours per week in 2003, critics worried that the change would leave physicians-in-training unprepared for the challenges of independent practice.

New research, published in July in the British Medical Journal (BMJ) and led by scientists in the Department of Health Care Policy in the Blavatnik Institute at Harvard Medical School, shows that these warnings were largely unjustified.

These new data are notable given that Teles and colleagues’ survey pointed to long working hours as one of the factors behind burnout among spine surgeons.

Following a series of high-profile patient injuries and deaths believed to stem from clinical errors caused by fatigue, medical accreditation agencies initiated a series of sweeping changes to the regulations governing resident hours and other aspects of training. These efforts culminated in 2003 with the US Accreditation Council for Graduate Medical Education capping the training of medical residents at 80 hours per week.

The analysis—believed to be the first national study examining the impact of reduced hours on physician performance—found no evidence that reduced training hours had any impact on the quality of care delivered by new physicians.

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increase in in-hospital complications. They remark that longer term follow-up will assess the impact of intravenous ketorolac on pseudoarthrosis.

Iyer and colleagues note that 115 patients met the inclusion criteria and were randomised to receive intravenous ketorolac, intravenous acetaminophen (also 39 patients) groups, or placebo (37 patients).

There was no difference between patients with regards to demographic or surgical variables.

The intravenous ketorolac group had “substantially lower” opioid use at 72 hours (181±156mg) compared to the intravenous acetaminophen patients (268±176mg) and those who received placebo treatment (315±183mg).

Essentially, intravenous Sravisht Iyer ketorolac was superior to both intravenous acetaminophen and the placebo, while intravenous acetaminophen was not superior to placebo treatment.

Similar trends were observed for opioid use per hour, and there were no differences in opioid related adverse events, drain output, haematocrit levels, serum creatinine, and transfusion rates.

Patients between the ages of 18 and 75, with lumbar fusion between levels one and two and no history of long-term opioid use were included in the study. Smokers and patients with contraindications to intravenous ketorolac or intravenous acetaminophen were excluded.

Intravenous ketorolac patients received either 15mg, if they were over the age of 65, or 30mg, if they were under 65 years old, every six hours for a total of 48 hours. Intravenous acetaminophen patients received 1,000mg every six hours and the placebo patients were also treated every six hours for 48 hours.

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Issue 52 | September 2019

ACDF

Congress of Neurological Surgeons’ Top Paper of 2019 goes to Spine Section RCT

The Congress of Neurological Surgeons (CNS) recently awarded their Top Paper of the Year and Spine Section Paper of the Year to an analysis of 10-year results from a prospective, randomised clinical trial comparing cervical disc arthroplasty (CDA) to anterior cervical fusion, conducted by George Ghobrial, William Lavelle, Jeffrey Florman, K Daniel Riew and Allan Levi. The CNS 2019 Annual Paper of the Year awards honoured research published in Neurosurgery from July 2018 to May 2019, which, according to a press release, “challenged dogma, created a paradigm shift, and/or encouraged surgeons to rethink approaches to patient care, big data, and trial results.”

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he winning paper, first published in February 2019, found that compared with anterior cervical discectomy and fusion (ACDF), fewer patients with the Bryan disc (Medtronic) required surgery for symptomatic adjacent level degeneration, but that this did not achieve statistical significance. However, analysis of combined study data using the Bryan and Prestige (Medtronic) discs showed “significant differences” in symptomatic adjacent level disease requiring surgery (SALDRS) as early as seven years.

Ghobrial and colleagues reveal that “significantly greater” overall success was maintained at every postoperative

interval, with an overall success rate of 81.3% with the Bryan disc and 66.3% with ACDF (p=0.005) without loss of motion preservation (8.69 degrees vs. 0.6 degrees). They note that reoperation at adjacent levels up to the 120-month visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (p=0.146).

Finally, the Bryan and Prestige disc groups, based on combined data, had a lower rate of second surgeries at the adjacent levels, up to the 84-month visit, compared to the pooled ACDF groups (6.9% vs. 11.7%; p=0.023).

The investigators analysed prospective randomised trial data comparing Bryan cervical disc arthroplasty to ACDF for

single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 years. Secondarily, 84-month data were pooled with Prestige cervical disc arthroplasty study data to provide overall rates of SALDRS. Previously, ten-year follow-up data from the US Food and Drug Administration (FDA) investigational device exemption (IDE) trial comparing Bryan cervical disc arthroplasty to ACDF had demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability. The objective of this study was to compare the 10-year rates of SALDRS. According to Ghobrial and colleagues, while ACDF has long been regarded as a “relatively safe, versatile, and effective”

Significantly greater overall success was maintained at every postoperative interval.” treatment for cervical spondylotic disease and other cervical pathologies with high rates of success and an acceptable periprocedural complication rate, one “overarching concern” has been the development of symptomatic

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adjacent level degeneration (SALD) after ACDF, thought to be the product of increased segmental motion, intradiscal pressures, articular surface loading, and strain.

They note that this “undesired outcome” was first described retrospectively in 374 patients by Hilibrand et al, who cited a 25.6% 10year rate of SALD, or 2.9% a year.

The Bryan cervical disc prosthesis was introduced clinically in 2002, followed shortly from favourable trial results from other cervical disc arthroplasty (CDA) devices, and increased attention has since focused on determining the difference in SALD between ACDF and CDA, with the hypothesis that CDA may restore favourable kinematics of the cervical spine, and therefore, will lower rates of SALD. The Top Paper award will be presented to senior author Allan D Levi (University of Miami Miller School of Medicine) at the CNS’ largest platform, the Annual Meeting, to be held this year in San Francisco, USA, 19–23 October.

“Neurosurgery Publications is delighted to continue the Neurosurgery Paper of the Year CNS awards at the 2019 CNS Annual Meeting,” said editorin-chief Nelson M Oyesiku. “We are incredibly lucky to have the brightest minds in neurosurgery submit their papers to Neurosurgery. It was difficult to narrow the field to the awardees; however, we are confident the selected papers each constitute a significant contribution in our field.”

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September 2019 | Issue 52

Conference coverage

Highlights of IMAST 2019 Paul Sponseller Comment & Analysis Paul Sponseller, president elect of the Scoliosis Research Society (SRS), talks to Spinal News International about the 2019 International Meeting on Advanced Spine Techniques (IMAST; 17–20 July, Amsterdam, The Netherlands). The mission of IMAST was to complement the Scoliosis Research Society Annual Meeting (SRS; 18–21 September, Montreal, Canada), focusing on more innovative techniques, which are in their earlier stages of development. Now in its 26th year, Sponseller believes the meeting “has an established place as one of the major meetings on the spine deformity calendar”.

SINCE THE SRS is the premier society providing spinal deformity education, it is held inside the USA 40% of and outside of the USA 60% of the time. IMAST and the Annual Meeting complement each other in that way: when one is held in the USA, the other is held outside the USA. IMAST 2019 was held in Amsterdam for the first time this year, and over 725 attendees from five continents (a mixture of orthopaedic surgeons and neurosurgeons) enjoyed the conference, one of the highest numbers in recent years. There were 75 peerreviewed papers presented, mostly in parallel sessions, and audience voting determined the best papers.

The Whitecloud award-winning Best Clinical Paper was by Sravisht Iyer (Hospital for Special Surgery, New York, USA), a prospective randomised double-

blind study showing that intravenous ketorolac reduces opioid consumption compared to intravenous acetaminophen or placebo after instrumented lumbar spine fusion while providing Improved pain control. The ketorolac group had nearly half the opioid use of the placebo group. There were no increased inhospital complications and a trend toward decreased length of stay. “These findings are encouraging; longer term follow up will assess the impact of ketorolac on pseudarthrosis”, Iyer stated.

A long-term (10-year) prospective randomised investigational device exemption (IDE) trial of cervical disc arthroplasty (CDA) versus anterior cervical discectomy and fusion (ACDF) at two contiguous levels was summarised

by Jeffrey McConnell (Leigh Valley Hospital, Allenstown, USA). Outcome

No increase in complication rates using ACR when compared to LLIF The results of a recent study indicate that anterior column realignment (ACR) via a lateral approach allows for the normalisation of spinopelvic parameters without additive complication risk when compared to lateral lumbar interbody fusion (LLIF).

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resenting author Praveen Mummaneni (University of California, San Francisco, USA) presented this conclusion at the 26th International Meeting on Advanced Spine Techniques (IMAST; 17–20 July, Amsterdam, The Netherlands).

The authors note that prior to this prospective multicentre review, it was known that ACR can be utilised for correction of adult spinal deformity (ASD), but that the additional benefit over LLIF alone was unclear.

In this prospective, multicentre review, the investigators found that use of ACR via a lateral approach for correction of ASD results in no increase in neurologic, vascular, or other overall complication rates, when

measures included a composite overall success scale, and also a comparison of adverse events. With >80% follow up in each group at 10 years, the overall success rate was 80% for CDA vs.

62% for the ADCF group. The authors conclude that “two-level CDA is a reliable, and perhaps better, alternative to fusion”. A subsequent symposium later in the meeting on ACDF versus CDA showed that equipoise remains among experts about whether one procedure is clearly better than the other.

A level one trial reported by Daniel Stein (Hospital for Special Surgery, New York, USA) and colleagues showed that topical steroid mixed in an absorbable gel matrix resulted in less dysphagia after multi-level ACDF surgery when compared to controls, and that the advantage remained up to one month of follow up.

On the cautionary side, Kevin Taliaferro (Henry Ford Hospital, Detroit, USA) presented a prospective randomised double blind study of patients undergoing posterolateral lumbar

Join the SRS in Athens, Greece, 1–4 April 2020.” fusion showed that teriparatide provided no significant advantage in fusion rate compared to placebo when assessed by helical computed tomography (CT) at one year after surgery.

The Basic Science award winner was a paper by Michelle C Welborn showing that collagen 10 biomarker (CXM, a breakdown product of collagen X from the growth plate which is broken down during endochondral ossification) is a real-time marker of growth velocity

which compares favourably with more traditional radiographic markers. While not clinically available, “This test may guide decision-making in bracing and growth-friendly surgery”, Welborn stated.

Several papers discussed the results of anterior non-fusion scoliosis correction (ASC) or vertebral body tethering (VBT).

Significant practice variation exists, but themes include delaying the procedure until at least Sanders 3 level maturity, and most papers reported reoperation rates slightly higher than those typically seen for posterior spinal fusion.

Several papers assessed the practical effect of advanced imaging technology (Navigation and robotics) in spinal surgery. A paper from Texas Scottish Rite Hospital (Dallas, USA) evaluated 1,667 spinal deformity operations by nine surgeons using fluoroscopicallyguided or freehand technique. Of over 20,000 screws placed, the incidence of misplaced screws was only 0.14% for thoracic and 0.08% for lumbar screws. “These results call into question the need for expensive navigation technology”, stated presenting author Lori Karol. A related paper presented

by Ivan Cheng (Stanford University Medical Center, Stanford, USA) used the MarketScan database to study the rates of neurological complications in 67,000 patients undergoing posterolateral lumbar fusions with or without navigation.

Patients whose surgery employed navigation had a slightly higher rate of neurological injury (1.4 vs. 0.4%), which was statistically significant.

Next year’s IMAST will be moved to the spring on a permanent basis.

Deformity specialists are encouraged to join the SRS in Athens, Greece, 1–4 April 2020.

Paul Sponseller is a professor of orthopaedic surgery at the Johns Hopkins School of Medicine (Baltimore, USA).

compared to using LLIF. However, 10 degrees. Patients were treated with they added that ACR is a more complex either circumferential minimally invasive procedure and should be performed only by surgery (cMIS) or hybrid MIS, with highly experienced surgeons. follow-up of at least one year. HealthIn addition, they note that optimisation related quality of life, including Oswestry of spinopelvic parameters was achieved Disability Index (ODI), visual analogue regardless of the technique employed, and score [VAS], and SRS-22, as well as while segmental radiographic changes were spinopelvic parameters, were captured. not specifically evaluated, regional and A total of 127 patients met the inclusion global parameters were not differentially criteria for the study, including 101 who impacted when comparing ACR and LLIF underwent LLIF and 26 who underwent impact. However, patients undergoing ACR Praveen Mummaneni ACR. The average age of the LLIF group did have a greater improvement in sagittal was 66.3, compared to a slightly higher vertical axis (SVA) compared to those who average of 67.8 in the ACR group. The average body underwent LLIF. mass index of both groups was similar—27.7 in the LLIF Mummaneni and colleagues included in the study group and 27.4 in the ACR cohort. patients 18 years old and above, and with either a coronal The groups had similar rates of prior spine surgery cobb of greater than 20 degrees, an SVA of more than (48.5% vs. 57.7%), cMIS (58.7% vs. 73.1%), posterior 5cm, a PT of greater than 20 degrees, or a PI-LL of above osteotomies (43.6% vs. 34.6%), levels instrumented (7.8 vs. 8), and interbody fusion levels (3.4 vs. 3.6). In addition, preoperative and postoperative spinopelvic parameters were similar between groups, except for postoperative SVA, which was higher in the LLIF group.

Preoperative and postoperative ODI, VAS, and SRS-22 scores were also similar between both groups.

Complication rates between groups were also similar (57.4% LLIF vs. 57.7% ACR), including neurologic (16.8% vs. 15.4%) and vascular (0% for both groups) injuries.

ACR is a more complex procedure and should be performed only by highly experienced surgeons.”

Issue 52 | September 2019

Conference coverage

CSM-Protect RCT results indicate a lack of effect on mJOA recovery but possible benefits on secondary outcomes Results of the CSM-Protect trial show that a six-week course of riluzole as an adjunct to surgical decompression for moderate-severe degenerative cervical myelopathy (DCM) has “no significant benefit” on the primary outcome of mJOA and “interesting effects” on three predetermined secondary outcomes—VAS neck pain, ASIA motor score and the SF36 physical function domain—which they feel “need to be viewed as exploratory”.

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ead investigator Michael Fehlings (University of Toronto, Canada) recently presented these findings during the Best Paper session at the 2019 meeting of the Global Spine Congress (GSC; 15–18 May, Toronto, Canada), concluding that the results also “confirm the significant improvement in neurological and functional outcomes with surgical decompression”.

Fehlings noted that a detailed analysis of the effect of riluzole on neurological complication (C5 palsy, deterioration of neurological function) is underway and that a longer duration (for example, three and six months) of riluzole “may warrant further study”.

He and his co-investigators suggest defining subsets of patients—such as those with neuropathic pain, who are at highest risk of perioperative neurological deterioration— who can potentially benefit the most from neuroprotective interventions.

Additionally, the development of more sensitive outcome measures (for gait and hand/arm function) is “needed”, as mJOA has “responsiveness limitations”.

Overall, Fehlings and colleagues conclude that “the effect of riluzole in reducing pain in DCM is of clinical interest, is associated with improved SF-36 physical function, and merits further study”.

DCM is the leading cause of spinal cause impairment, and although surgical decompression improves function

and QOL, Fehlings remarked that many patients are left with residual disability and there is a 7–11% risk of neurological deterioration after decompression. The investigators hypothesised that riluzole would enhance neurological recovery, attenuate neuropathic pain, and reduce perioperative neurological complications following surgical decompression for DCM. Fehlings described the study as a multicentre, placebocontrolled, double-blinded, randomised trial, conducted

A detailed analysis of the effect of riluzole on neurological complication is underway.” in 16 sites across North America. Enrolment took place between March 2012 and June 2019, culminating in a study population of 300, all with moderate-to-severe symptomatic DCM (mJOA 8–14), no prior cervical spine surgery, and all undergoing elective spinal decompression.

The participants were aged between 18 and 80.

Riluzole was given orally in 50mg doses every 12 hours for 14 days before surgery and continued for 28

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days after surgery. For the control, a placebo was given on the same schedule. Outcomes were recorded at enrolment, on admission, and then after 35 days, six months, and one year. The primary outcome was change in mJOA (six months) and secondary outcomes were change in Nurick grade, neck disability index (NDI), SF-36, EQ-5D, ASIA motor and sensory scores, grip strength, and grip VAS (six months).

Patients were randomised 1:1 and subjects, physicians, and data collectors remained blinded to treatment allocation throughout the study. The investigators note that to have 80% power to detect an effect size of 0.35 Cohen’s d (0.9–point of different in mJOA), a sample size of n=270 was needed.

In terms of statistical analysis, between-group comparisons of change in outcome scores from baseline were made using mixed-effects models for repeated measures; unstructured covariance matrix; fixed effects for treatment group (riluzole versus placebo), time (hospital admission, 35 days, six months, one year after surgery), and time-by-treatment interaction.

A total of 300 patients were randomised, and 290 underwent surgery, of which 141 received riluzole and 149 were allocated to the placebo group. The mean age of the cohort was 58±10.1 years, and there were 129 females (44.5%) in the group. The rate of follow-up was 90% at six months, and 79% at one year.

Sixty seven patients in the riluzole group experienced hypertension, compared to 63 in the placebo group.

Diabetes occurred in 23 patients in the riluzole group, compared to 12 in the placebo group, and anxiety and depression symptoms were noted in 31 and 29 patients, respectively.

The investigators report no series drug-related adverse events, and no patient had to stop drug treatment. They found that at six months, surgery resulted in “significant improvement” in all outcomes, and the primary outcome analysis found improvement with surgery, but no additional benefit with riluzole.

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September 2019 | Issue 52

Robotics

Current evidence and future applications for robotics in spinal surgery Ronald A Lehman Nathan J Lee Comment & Analysis While robotic technology is still in its infancy, current evidence suggests a promising future for its application in spine surgery, argue Ronald A Lehman and Nathan J Lee. Here, they discuss the results of recent studies into the safety and efficacy of this emerging technology, and conclude that there is an “attractive future” for robotics in spine surgery, defined by increased accuracy, enhanced safety, and reduced costs.

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obot-assisted platforms are currently at the leading edge of innovation in spine surgery. This emerging technology is attractive to both surgeons and patients for a number of potential reasons. These include increased accuracy of pedicle screw placement versus historical freehand techniques, minimally invasive applications (small incisions and less dissection, retraction, bleeding, and infection), decreased radiation exposure to the operator versus traditional fluoroscopically-assisted techniques, and reduced human error including fatigue, tremor, and precise repetition. Robotic technology has only been recently introduced in spine surgery, but current literature is already demonstrating promise.

The improved accuracy and precision of pedicle screw placement is perhaps the most lauded aspect of robot-assisted surgery. For the conventional freehand technique, the reported pedicle screw misplacement rates in the thoracolumbar spine ranges from 2–31%.1–4 The majority of current literature suggests that roboticassisted placement of pedicle screws is comparable or significantly higher.

Devito et al performed a multicentre, retrospective review evaluating the placement of 3,271 pedicle screws. Based on postoperative CT analysis, 98.3% of screws were found to be within the 2mm “safe zone,” and only 1.7% of screws had a breach greater 2mm.5 In another retrospective review, Kantelhardt et al compared conventional freehand versus open robotic-assisted versus percutaneous robotic-assisted pedicle screw placement techniques and found an accuracy rate of 94.5% for the combined robotic-assisted group versus 91.4% for the freehand group.6 A recent meta-

analysis of six randomised controlled trials demonstrated superior Grade A accuracy (as described by the GerztbeinRobbins classification) and fewer proximal facet joint violations in the robot-assisted group versus conventional freehand group.7 Recently, our group published a propensity-matched analysis on the accuracy of free-hand versus robotic guidance for placement of S2 alar-iliac screws. There was no significant difference in the overall accuracy (94.9% vs. 97.8%, respectively).8

There is good consensus within the literature that there is reduced time to radiation during robotic-assisted surgeries compared to conventional techniques. In a prospective randomised trial, Roser et al demonstrate an average radiation time of 15.98 seconds and 31.5 seconds for the robotic-assisted and the traditional freehand technique, respectively.9,10 Similarly, a retrospective cohort study demonstrated an average of 34 seconds in the robotic-guided group compared to 77 seconds in conventional cases.

Interestingly, a single-centre prospective randomised controlled study shows no significant difference in intraoperative radiation time between freehand and robotic groups.11 In comparison to robotassisted surgery, the freehand technique necessitates fluoroscopic confirmation, which may increase radiation to the patients.

Many articles comparing robotics to open freehand surgeries show reductions in length of stay. In a retrospective study comparing open robotic versus open freehand cohorts, the average length of stay was 11.6 vs. 14.6 respectively.6 In a prospective randomised clinical trial, the average length of hospital stay for the robotic-guided minimally invasive group versus the fluoroscopic guided open surgery group was 6.8 and 9.4 days, respectively.10 It is likely that these reductions in hospital stay are influenced by the minimally invasive nature of the robotic surgical approach as opposed to other technical aspects of the robot.

Nevertheless, these finding suggest a potential area that may offset the high costs of owning and maintaining robotic systems.

Early applications of this technology have primarily focused on the placement of pedicle screws, which is arguably one of the most technically demanding and high-risk aspects of spine surgery.

Overall, current literature suggests that

Mazor X Stealth Edition (Medtronic)

Robotic technology has only been recently introduced in spine surgery, but current literature is already demonstrating promise.”

robotic spine surgery can be a safe and efficient method for screw placement.12 Spine surgeons should familiarise themselves with this developing technology since its applications will likely expand beyond the scope of pedicle screws. Our research group published a study demonstrating that a bone-mounted miniature robotic-guided system was able to achieve spinopelvic fixation using S2 alar-iliac screws safely and reliably.13 Next steps may include further integration of robotics in the workflow of deformity cases. Robotic systems may be equipped to place not only screws but also customised rod constructs. MRI-based navigation could enable soft tissue handling, including disc work and tumor resections.14–16 When new technologies are adopted in healthcare, it should provide a path to higher quality care for the patient in a safer and more cost-effective manner. For this reason and the growing evidence that support these goals, robotic spine surgery remains an attractive future that may have the potential to change the landscape of spine surgical care. As the data supporting the clinical and economical value grows, it is conceivable that the use of robotic-assisted technology will be considered as “standard of care.”

Ronald A Lehman is a professor of Orthopaedic Surgery at the New YorkPresbyterian Hospital (New York, USA).

Nathan J Lee is an Orthopaedic Surgery resident at the New York-Presbyterian.

References: 1. Modi HN, Suh SW, Hong JY, Yang JH. Accuracy of thoracic pedicle screw using ideal pedicle entry point in severe scoliosis. Clinical Orthopaedics and Related Research. 2010;468(7):1830–7.

2. Kim YJ, Lenke LG, Bridwell KH, et al. Free hand pedicle screw placement in the thoracic spine: Is it safe? Spine.

2004;29(3):333-42; discussion 42.

3. Karapinar L, Erel N, Ozturk H, Altay T, Kaya A. Pedicle screw placement with a free hand technique in thoracolumbar spine: Is it safe? Journal of Spinal Disorders & Techniques. 2008;21(1):63–7.

4. Parker SL, McGirt MJ, Farber SH, et al. Accuracy of free-hand pedicle screws in the thoracic and lumbar spine: Analysis of 6,816 consecutive screws.

Neurosurgery. 2011;68(1):170–8; discussion 8.

5. Devito DP, Kaplan L, Dietl R, et al. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: Retrospective study.

Spine. 2010;35(24):2109–15.

6. Kantelhardt SR, Martinez R, Baerwinkel S, et al.

Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. European Spine Journal. 2011;20(6):860–8.

7. Gao S, Lv Z, Fang H. Robot-assisted and conventional freehand pedicle screw placement: A systematic review and meta-analysis of randomised controlled trials.

European Spine Journal. 2018;27(4):921–30.

8. Shillingford JN, Laratta JL, Park PJ, et al. Human versus robot: A propensity-matched analysis of the accuracy of free hand versus robotic guidance for placement of S2 alar-iliac (S2AI) screws. Spine.

2018;43(21):E1297–e304.

9. Roser F, Tatagiba M, Maier G. Spinal robotics: Current applications and future perspectives. Neurosurgery.

2013;72 Suppl 1:12–8.

10. Hyun SJ, Kim KJ, Jahng TA, Kim HJ. Minimally invasive robotic versus open fluoroscopic-guided spinal instrumented fusions: A randomised controlled trial. Spine. 2017;42(6):353–8.

11. Ringel F, Stuer C, Reinke A, et al. Accuracy of robotassisted placement of lumbar and sacral pedicle screws: A prospective randomised comparison to conventional freehand screw implantation. Spine.

2012;37(8):E496–501.

12. Tan LA, Lehman RA. Robotic-assisted spine surgery using the Mazor XTM System: 2-dimensional operative video. Operative Neurosurgery (Hagerstown, Md). 2019;16(4):E123.

13. Laratta JL, Shillingford JN, Lombardi JM, et al.

Accuracy of S2 alar-iliac screw placement under robotic guidance. Spine Deformity. 2018;6(2):130–6.

14. Smith JS, Shaffrey CI, Ames CP, Lenke LG. Treatment of adult thoracolumbar spinal deformity: Past, present, and future. Journal of Neurosurgery: Spine.

2019;30(5):551–67.

15. Kochanski RB, Lombardi JM, Laratta JL, et al. Imageguided navigation and robotics in spine surgery.

Neurosurgery. 2019;84(6):1179–89.

16. Sayari AJ, Pardo C, Basques BA, Colman MW. Review of robotic-assisted surgery: What the future looks like through a spine oncology lens. Annals of Translational Medicine. 2019;7(10):224.

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September 2019 | Issue 52

Robotics

Robotic technology: Where does it find its niche?

Redd Warburton, a senior executive search consultant specialising in orthopaedics and spine, argues that while there are significant hurdles to overcome for robotics to be adopted within routine spinal surgery, robotics is here to stay.

Redd Warburton Comment & Analysis ROBOTICS WITHIN SURGERY is still very much in its infancy, with as little as 10 years of data to prove its clinical worth on accuracy and long-term patient outcomes, and with the costs/ time associated with robotics, it is no surprise that the adoption process has been slow. It is suggested that there is resistance to their use, as some surgeons “feel disempowered by robotics” (Keith Jackson, former CEO, JRI Orthopaedics).

The challenge with the adoption process amongst surgeons is therefore proving its worth as bringing an expensive and intricate device into surgery where surgeons feel they can perform sufficiently without.

Relying on robotic assistance within

spinal surgery runs the risk of de-skilling surgeons over time as the difficult element of their job is significantly reduced—particularly if robotics replaces not only routine procedures, but the more technical cases.

Furthermore, it has been suggested that robotic assistance unnecessarily alters how relatively commonplace surgeries are now performed. This runs the risk of adding additional cost burns whilst jeopardising surgeons’ enjoyment of dealing with these cases themselves.

For robotics to be truly revolutionary, it should change what surgeons are currently doing, not just enhance routine surgeries.

A study conducted by the Society

of Minimally Invasive Spine Surgery found that surgical outcomes for robotic-assisted spine surgery showed significantly less complication than the outcomes of surgery performed freehand. Complication rates varied from just 4% (robotic-assisted) to 12.8% (free-hand) when taking all other external factors out of consideration such as surgeon, patient age, gender, body mass index and length of surgery. The reduction in the risk of postoperative surgical complications could in turn result in significantly shorter recovery times for patients.

Further to this, robot-assisted pedicle screw placement has been found to have a substantially higher level of accuracy than those placed by hand, hence an existing preferential treatment towards pedicle screw placement in this way, leading some to ask whether more spinal surgeries should be utilising robotics.

However, issues arise when the process of preparing a robotic surgery case is scrutinised. It has been suggested that the time required to invest in preparing a robotics case could be unjustified unless talking about a complex deformity case (Scott Way, COO, Statera Spine). The increasing time constraints upon surgeons means that in many cases “surgeons just do not have an extra 15 minutes to spend on each patient” in order to programme the robot to for the particular case in hand (Ben Pitcher, CCO and Joe Walland, CEO from Medicrea).

The key missing ingredient for robotics to work in degenerative cases

is good data on the patient’s anatomy without significant work. There are companies within the field that are now offering pre- and postoperative support with regards to software in order to remove any significant extra work for the surgeons—a pioneering solution which could drastically change the rate of adoption for robotic assistance within spinal surgery.

In addition, there are the huge cost implications of introducing robotics into routine spinal surgery into health systems already constantly battling against financial restraints. The cost is not just the initial purchase, but also the significant burden of maintenance and ongoing programming.

Present studies suggest that the biggest barriers to market are the time required to invest in preparing a robotics case and the significant cost of investing in robotic technology. However, this has to be weighed against the benefits to both patients—in terms of accuracy of the surgery itself and the subsequent recovery time, and to the surgeons in alleviating the burdens already placed upon them.

The adoption process is likely to be slow and there will be setbacks along the way—but with clinically-supported trials and ever-increasing manufacturing advances, the market has the potential to be revolutionary.

Redd Warburton is senior executive search consultant at CSG Talent, specialising in orthopaedics and spine.

Issue 52 | September 2019

Advertorial

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ADVERTORIAL SPONSORED BY AESCULAP

Focus on the essentials—avoid distractions Spinal surgery is changing. The increasing demands on treatment concepts are making hospital processes more complex, and all departments are affected. Hospitals need more than just products—they need sustainable solutions that improve daily work in order to face the challenges of spinal surgery. This is where Ennovate® comes in. A spine platform that makes it possible to work across a broad range of pathologies and approaches with the versatile Ennovate® PentaCore® Screw, an implant that unites multiple screw attributes and facilitates activation between different screw types. In addition, the platform offers just-in-time delivery systems of sterile-packed implants which, together with a streamlined fully modular instrument set, standardize and streamline all sterile goods related processes. Here, surgeons, operating room (OR) staff and central sterile services department (CSSD) staff talk through their experiences with Ennovate®, and how it has a positive economic effect on their respective hospitals, while also improving surgical outcomes.

Ennovate®—A solution that goes far beyond fusion

Ennovate® is the epitome of a peerless platform, replete with technological advancements that leverage surgical experience and greatly increase clinical efficiency. One of the platform’s pillars is the Ennovate® PentaCore® Screw, a feat of biomechanical engineering. The unique design allows surgeons and clinics to use only one screw design for all surgical requirements without compromising handling or biomechanical performance.

Dr Manuel J de la Torre Gutiérrez (head of Neurosurgical Services, Ruber Hospital, Madrid, Spain) emphasizes that “the design is exceptional.

Ennovate® enables me to treat all different pathologies and indications for surgery, and enables the fulfilment of my needs as a surgeon.” Professor Bronek Boszczyk (chief physician of the Department of Spinal and Scoliosis Surgery, Schön Klinik, Vogtareuth, Germany) continues: “PolyLock® provides powerful and important benefits for my patient collective, as well as for my surgical techniques and treatment regimen. The conversion of the polyaxial screw to the monoaxial screw at any point during surgery, with or without a rod and set screw, and reversible at any time point or multiple times during an operation allows for better options.” For the first time, surgeons are enabled to perform an unhindered rod-free correction of the spine and thus a therapy tailored to the individual pathology and needs of the patient.

The screw offers far more than new treatment concepts and powerful reduction. It also sets new standards in surgical experience, biomechanics, and bone anchorage with the anatomically-inspired cutting-edge PentaCore®. Professor Thomas Blattert (chief physician of the Department of Orthopaedics and Traumatology, Specialized Orthopaedic Clinic

Schwarzach, Schwarzach, Germany) explains the clinical values based on his daily challenges and how he manages them with PentaCore®. “As a surgeon dealing with elderly patients with poor bone quality, you always seek pedicle screws that will give you a good purchase in the bone and optimal stability, both directly after surgery and in the longrun. My experience during surgery and based on the tactile feedback I got in these cases confirmed my expectations of this screw.” All surveyed surgeons, among them Professor Martin Repko (head of Orthopaedic Department and University Centre for Scoliosis and Spinal Deformities, University Hospital Brno, Brno, Czech Republic), are impressed with the power of the system, citing the great grip and traction as well as capability for an outstanding bone purchase and anchorage parallel to the ability of a highly accurate screw placement. Christopher Lee (consultant orthopaedic surgeon, Hull, UK) interprets the advantages of PolyLock®’s intraoperative flexibility and PentaCore®’s outstanding performance from a holistic perspective: “You have one implant that has many functions, which means you keep less product on your shelf, so that is a benefit for the hospital”.

This advantage, and the reduction of inventory to a single-source platform, is reflected in the result

Ennovate® is the most significant invention in pedicle screws over the last decade.”

B. Braun AESCULAP® solutions add true clinical values to every stage of the patient pathway and clinical processes

Simply smart—Ennovate® can be tailored according to hospital needs, improving efficiency and outcomes

of a health economic survey conducted across 95 spine centers. A practical example is provided by the Regional Hospital of Tuttlingen, Germany. The surgeons, Dr Manfred Petrick and Dr Herrero y Calle (Clinic for Neurosurgery and Spine Surgery) successfully introduced Ennovate® in cooperation with the OR and CSSD managers and their teams.

“Ennovate® captivates with its simplicity. We were able to reduce the number of trays by approximately 50% and simultaneously improve the efficiency of our whole patient care value-added process. Furthermore, the surgical workflow has been streamlined by reducing the number of steps for the same treatment concepts.”

Overall, the total time per surgery has been reduced.

This has enormous potential if one considers the cost savings over the total number of cases per year.

They further state that the individually configurable instrument trays and supply cart (for sterile packed implants) have created a redundancy-free platform tailored to their needs, that result in less time required for preparations, and facilitates a fast adaptation to the system, thanks to the all-for-one-cases Ennovate® PentaCore® Screw.

“Fewer instruments mean less effort in the CSSD. The fact that the instruments can be washed and processed in the OrthoTray®, a validated washing and sterilization tray, allows us to achieve reliable and reproducible quality.” In addition, the change to sterile implants saves an average of five hours and thus creates new capacities in the CSSD, which has a big impact on further cost reductions. In addition, sterile packed implants ensure continuous availability, seamless tracking and prevention of implant-related infections.

“The trays are easy to understand, the implants are well labelled, and so are the instruments. Everything works well together,” says Lee, pointing out that the small number of set titles are clearly structured, which in turn limits complexity of storing and delivering the instruments.

From a holistic point of view, sterile-packed implants improve patient safety (since implants are not reprocessed any more), facilitate documentation and traceability, and digitize and accelerate ordering processes. The use of just one platform has been shown to have a significant economic effect on the hospital, improving process flow and logistics while reducing costs across all departments.

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September 2019 | Issue 52

Conference coverage

State of the art evidence and novel developments in biologics for spine fusion Scott Boden Comment & Analysis The opening symposium at the 2019 Global Spine Congress (15–18 May, Toronto, Canada) focused on cutting edge updates in spine surgery. During this session, Scott Boden addressed the topic of biologics in spine surgery, detailing state of the art evidence and novel developments in the field. Here, for Spinal News International, he gives a summary of his talk.

S

ince the 1990s, there has been a recognition that rigid internal fixation alone without favourable biologic healing is not sufficient to generate consistent spine fusions.

This realisation is especially true in the posterolateral spine which is one of the body’s most challenging healing environments. Around 1990 demineralised bone matrix products emerged on the market with variable osteoinductive activity. There was a brief phase of platelet rich plasma which did not produce consistent results. In 2002, recombinant human bone morphogenetic protein-2 (rhBMP-2) was approved by the US Food and Drug Administration (FDA) for specific applications in the lumbar spine and this sparked an even greater focus on biologics for spine

fusion. This approval came 37 years after Marshall R Urist’s seminal hypothesis that demineralised bone contained a protein capable of modulating bone regeneration from scratch and 14 years after the cDNA for BMPs was cloned and sequenced.

After approval, rhBMP-2 physician directed usage expanded substantially but ultimately was limited by cost, local side effects, and limited regulatory approval. Those limitations opened the door for increased interest in bone marrow concentrates which did not produce reliable enhancements to spine fusion. In the last decade, a number of allograft products processed to enhance mesenchymal stem cell preservation have become popular, but again with limited evidence in humans that the

active ingredient (the mesenchymal stem cells) are providing any additive biologic value over the carrier which is often demineralised bone matrix. The challenge with mesenchymal stem cells is that the available number is much less than some preclinical studies have suggested are needed to produce bone and the lack of specific growth factors and other environmental stimuli needed to drive these pluripotent cells down the osteogenic pathway.

At present, recombinant or purified BMPs when delivered in the proper concentration on the proper carrier have the highest demonstrated osteoinductive potential as measured by the ability to generate bone from scratch in a nonbone environment, like the posterolateral spine. Local side effects may include seroma formation, local nerve inflammation, ectopic bone formation, and local cancellous bone resorption.

These local side effects are often, but not always, related to a higher concentration than needed of BMP for a given healing environment. Although there were concerns raised about whether rhBMP-2 increased the risk of cancer in patients

Studies support [rhBMP-2] adding value in multilevel ACFs.” based on the original relatively small clinical trials, larger database studies have failed to document any increased risk of cancer, and in fact may suggest a slightly lower risk, with the exception of pancreatic cancer.

Given the relatively high cost of rhBMP-2, it is critical to determine which clinical scenarios can justify the increased cost. Based on the “delta” of

Operative versus non-operative decisionmaking of experienced surgeons “may be emulated with trained AI algorithms” A recent study developed models capable of “excellent discrimination” between operative and non-operative management of patients based solely on baseline preoperative values.

According to the authors, patient-reported outcome measures (PROMs) were particularly instrumental in making these predictions.

THE AUTHORS, ALAN H Daniels (Brown University, Providence, USA) and colleagues, clarify that these models predict patients who received surgery, and not necessarily those who should undergo or will do well with surgery. They suggest that “future investigations may evaluate the implementation of such models for decision support in the clinical setting”. Daniels recently presented these conclusions at the 26th International Meeting on Advanced Spine Techniques (IMAST; 17–20 July, Amsterdam, The Netherlands), sponsored by the Scoliosis Research Society.

Daniels and colleagues note that adult spinal deformity patients exhibit complex and highly variable pathology and that the decision to operatively manage patients is largely subjective and varies based on

surgeon training, preference, and experience. This study therefore sought to develop models capable of discriminating between patients receiving operative versus non-operative treatment.

The investigators performed a retrospective analysis of a multicentre, prospectively-defined, consecutive cohort of 1,503 adult spinal deformity patients. The cohort was divided in a 70:30 split for training and testing, and the outcome measure was operative treatment, defined as those undergoing surgery up to one year after their baseline visit.

Predictive variables included patient demographics, their past medical history, PROMs, and radiographic parameters. Statistical analysis included random forest, elastic net regression, logistic regression, and support vector machines (SVMs) with radial and linear kernels.

increased fusion success when rhBMP-2 is added, studies support it adding value in multilevel anterior cervical fusions (ACFs), posterolateral fusions, and potentially in biologically challenged hosts (diabetes, chemotherapy, steroids, smokers, etc). There are some development efforts around second generation designer recombinant BMPs that might be less resistant to BMP inhibitors and thus require lower doses, but it is not known if the safety profile will be any different, and the current manufacturing cost of a recombinant protein is still higher than desired for routine use in orthopaedics.

In recent years, several proteins (Nell1) and small peptides (P-15), while not osteoinductive are still being investigated as to whether they can enhance spine fusion healing. LMP-1 was an intracellular protein discovered in 1998 that was osteoinductive, but required a gene therapy delivery technique which presented unnecessary clinical risks for the spine fusion population.

Subsequent studies of the mechanism of action of LMP-1 showed that it resulted in increased responsiveness of human MSCs to BMPs and led to the development of small molecules that could potentially mimic the activity of BMP without the extraordinarily high cost associated with manufacturing a recombinant human protein. The LMP-1 derived small molecules have demonstrated the possibility for a small molecule to possess osteoinductive properties and may open the door in the future for safer and more cost-effective strategies to activate the BMP pathway.

Scott Boden is a professor of orthopaedic surgery at Emory University School of Medicine, director of the Emory Orthopaedics & Spine Center, and chief medical officer/chief quality officer at Emory University Orthopaedics & Spine Hospital (Atlanta, USA).

Model performance was evaluated by AUC. Daniels and colleagues report that predictive performance was “excellent” for SVM radial, SVM linear, and elastic net (AUC>0.9), and random forest performed “statistically inferior” to the other tested models (p>0.05).

In the training and testing sets, 69% (n=727) and 69.1% (n=311) of patients received operative management, respectively. Upon evaluation with the testing dataset, performance for SVM linear (AUC=0.91), elastic net (0.913), and SVM radial (0.914) models was “excellent”, and random forest model performed “very well” (0.83).

The investigators summarise: “This study utilised

Patient-reported outcome measures (PROMs) were particularly instrumental in making these predictions.” a variety of modern machine learning techniques to predict operative versus non-operative management of adult spinal deformity surgery patients,” and “the best models exhibited excellent discrimination”.

Issue 52 | September 2019

Microbes on explanted pedicle screws “may be a possible cause of spinal implant failure” According to a recent study, the lowvirulent microorganisms frequently detected on pedicle screws by using sonication may be an important cause of implant loosening and failure. Additionally, the investigators found that a longer surgical duration increases the likelihood of implant colonisation with subsequent screw loosening. Overall, they concluded: “Sonication is a highly sensitive approach to detect biofilm-producing bacteria, and it needs to be integrated into the clinical routine for optimised treatment strategies.”

THE NEW RESEARCH, conducted by Vincent Prinz (Charité Universitätsmedizin Berlin, Germany) and colleagues, was published recently in the Journal of Neurosurgery: Spine.

Pedicle screws are often used to secure surgically implanted hardware to the spine in patients with spinal disease or spinal trauma. In some cases, these screws loosen over time, leading to spinal instability and consequent pain. This is a common complication of spine surgery. One reason suggested for pedicle screw loosening is implant-associated

Pedicle screws infection, but until now there has been little clinical evidence to support this theory.

The study focused on 82 patients who underwent surgery during which a spinal hardware implant had to be removed. None of these patients had clinical or laboratory evidence of active infection, and there was no obvious sign of infection during surgery. Following surgery, sonication was used to detect the presence of microbial biofilms on the extracted hardware. This application of sound wave energy breaks apart any sticky biofilm covering surgical implants, separating microorganisms that inhabit it. The microorganisms that had colonised the implants were then examined to specify what types were present.

The authors found evidence of pedicle screw

The result of our study will add to a paradigm shift in spine surgery.” loosening in 54 of the 82 patients; the other 28 patients formed a control group. Sonication verified microbial colonisation of extracted hardware with one or more bacteria in 22 (40.7%) of the 54 patients with pedicle screw loosening. Sonication found no microbial colonisation in hardware removed from the 28 patients in whom there was no pedicle loosening.

The most commonly found microorganisms were identified as coagulase-negative staphylococci (specifically Staphylococcus epidermis, S hominis, S lugdunensis, S haemolyticus, S cohnii, and S saprophyticus). These commensal bacteria are part of the normal flora covering human skin and mucous membranes, where they rarely cause harm to their hosts.

The second most commonly found microorganism

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was Cutibacterium acnes, which, as its name indicates, causes acne and is also commonly found on human skin.

All these bacteria carry a low level of virulence. When they aggregate on medical devices implanted within a patient, they form biofilms and can produce infections that show no clinical symptoms and are not easily detected.

The authors examined patient files to find the durations of the initial surgeries in which spinal hardware had first been implanted in the spine. They found a significant difference between the length of surgery in patients in whom microbial colonisation of hardware was detected (mean 288±147 minutes) and patients in whom no microbial colonisation was found (mean 201±103 minutes).

Based on the relationship between pedicle screw loosening and microbial colonisation, the authors suggest that patients in whom infected hardware is replaced would benefit from “systemic biofilm-active antibiotic therapy to prevent new screw loosening.”

“Alternatively,” they add, “local antibiotics may be applied, such as the antimicrobial coating of screws or application of local antimicrobial hydrogel or bone substitutes.”

When asked about the importance of the study, Peter Vajkoczy, one of the investigators, commented: “The results of our study will add to a paradigm shift in spine surgery, if not more generally, to the common handling of medical hardware implants. Our increasing awareness of slow virulent infections as a cause of late hardware failure has changed our concept of prevention and treating this unfortunate complication of spine surgery.

Today, strategies are needed to prevent perioperative implant colonisation, disrupt biofilms, and actively search for implant infections by using sonication and advanced microbiological analysis at the time of re-operation. The good news is that infection is a complication that can be treated successfully, if properly diagnosed.”

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September 2019 | Issue 52

Endoscopic technology

Endoscopic technology and the future of spine surgery Sebastian Ruetten Comment & Analysis In the 1980s, the first attempts at endoscopic lumbar spine surgery were made. One of the key figures in the development of this technology, Sebastian Ruetten (St Anna Hospital, Herne, Germany) adopted spinal endoscopy and applied it for interlaminar endoscopic approaches in the early 2000s. Ruetten talks to Spinal News International about the evolution of this technology in relation to spine surgery, and how it might develop in the future. He concludes that, due to continued positive results, “the method is spreading around the world”.

How has the interlaminar endoscopic approach developed?

We now usually use the term “fullendoscopic” to describe these techniques.

We introduced this terminology in the early 2000s as it distinguishes them from endoscopy-assisted systems. It defined a surgical approach under continuous view and irrigation using a uniportal approach, i.e. all instruments are introduced through an intra-endoscopic working channel.

After we had first developed the lateral access for the transforaminal approach, the spinal canal could be reached directly and sufficiently for decompression of disc herniations.

Nevertheless, limitations soon became apparent, e.g. due to the abdominal organs, the pelvis, and in mobility, so the range of indications was narrowed and the full-endoscopic interlaminar access was therefore developed. In this method, it was often necessary to resect bone, so the corresponding cutting systems needed to be developed. This in turn made it possible to expand the range of indications to include spinal canal stenoses.

Today, many different endoscopes with all the corresponding instruments are available. The main indications are all forms of disc herniations and spinal canal stenoses. A modified interlaminar approach was also the basis for the development of the posterior fullendoscopic techniques on the cervical and thoracic spine.

How does the endoscopic technique compare to conventional surgery?

First of all, it should be emphasised that especially for disc herniations, good surgical outcomes can also be

achieved with conventional techniques, especially microscope-assisted methods.

Nevertheless, the full-endoscopic approach can represent a further step in development. An increasing number of full-endoscopic techniques are used around the world today.

In parallel to this, many scientific studies are conducted and published.

Based on the available results, fullendoscopic techniques have advantages over conventional procedures. The advantages include lower rates of complications such as dural tears, nerve damage or infections, better clinical results, shorter operation times, and improved cost-effectiveness.

One difficulty seen in practice is the steep learning curve. A certain level of specialisation within a spine centre is certainly necessary to achieve the high level of technical skill need for a number of cases.

What are the limitations of endoscopic spine surgery, and how can these be overcome?

Full-endoscopic techniques are currently used mainly for decompression operations on the spine. Other goals, e.g. inserting implants, have been achieved only in isolated cases and are not widely feasible. However, we do not consider this to be a disadvantage, as compressive pathologies constitute the defined range of indications. It is also not evident at this time whether the indications can be expanded in a technically satisfactory manner. The focus of full-endoscopic techniques is on decompression.

However, expansions of the indications have been reported, for example use in tumorous processes.

There may be additional difficulties,

The effectiveness and superiority of new techniques must always first be proven in comparison with existing methods.” as with many minimally invasive techniques, in the peri- and intraoperative planning and precise execution. Work is already being done to remedy this, e.g. with navigation or augmented reality.

The growing use of the methods should be matched by speeding up the learning curve and conveying the operative skills by expanding training programmes and qualified training centres.

Technical developments are currently being made in endoscopes and equipment, for example LED light sources, chip-on-the-tip endoscopes, or wireless solutions.

What do you think are the possibilities of endoscopic technology?

Due to the excellent intraoperative view, less trauma, and the potential advantages mentioned above, full-endoscopic techniques represent a real advance in the surgical treatment of disc herniations and spinal canal stenoses, for example.

As already mentioned, in our opinion, the current focus is on decompression alone.

What do you think endoscopic technology means for the future of spine surgery?

There are already additional areas for full-endoscopic techniques for decompression in the cervical and thoracic spine, where these techniques are increasingly widespread. We are currently seeing some reorientation such as the introduction of arthroscopic or

Intraoperative view after decompression

laparoscopic techniques. It seems that younger spine surgeons around the world grow up with full-endoscopic techniques, which are increasingly part of their normal spine surgery repertoire and are used on a daily basis. Full-endoscopic operations for disc herniations and spinal canal stenosis are today a clear alternative to conventional techniques, even taking the criteria for evidencebased medicine into consideration.

Nevertheless, we continue to stress that a defined range of indications is increasingly covered by full-endoscopic techniques, but that there are still other pathologies and surgical treatment goals that can be adequately achieved only with non-full-endoscopic methods.

What has been the reaction to this technology?

We started developing this technique 20 years ago. There was a good deal of scepticism of course, as so often when new approaches are introduced. Not only from others, but from ourselves as well. But in our opinion, this is not only correct, this is the way it should be, as the effectiveness and superiority of new techniques must always first be proven in comparison with existing methods. Now that it has been proven for many years, the method is spreading around the world. It is only natural that it is sometimes easier for the younger generation to go down new paths.

Sebastian Ruetten is an orthopaedist and traumatologist at St. Anna Hospital in Herne, Germany.

Issue 52 | September 2019

Low back pain

Sleep disorders predict increased healthcare visits and costs for low back pain The presence of a sleep disorder has a “significant and unique effect” on back painrelated healthcare use—beyond the impact of pain intensity, disability, and other factors, according to a study recently published in Spine. Authors Daniel Rhon (Brooke Army Medical Center, San Antonio, USA) and colleagues believe that assessing sleep disorders in patients with back pain “could provide an important indication of risk for high painrelated healthcare use.”

T

he study included 757 patients with low back pain attending self-management classes at a US military hospital. More than two-thirds of patients were men; over 80% were military service members.

The researchers assessed standard scores for pain intensity and disability, along with the presence of diagnosed sleep disorders and daytime sleepiness. These factors were evaluated for association with the amount of healthcare for low back pain (total number of medical visits and costs of related care) in the year after the selfmanagement classes.

As a group, the patients had relatively mild back pain: the average pain score was 2.4 out of 5 and average disability score 18.7 out of 100. However, 26% had a diagnosed sleep disorder—most commonly insomnia.

“The number of visits for low back pain was significantly associated with pain intensity, disability, and history of sleep disorder,” Rhon and colleagues write. Pain, disability, and diagnosed sleep disorders were also linked to increased costs for treating back pain. Daytime sleepiness, although a key symptom of sleep disorders, was unrelated to healthcare visits or costs.

Sleep disorders were associated with higher low back

The number of visits for low back pain was significantly associated with pain intensity, disability, and history of sleep disorder.”

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pain-related healthcare visits and costs at all levels of pain and disability. For example, at a disability score of 20, the average number of low back pain-related healthcare visits was 5.4 for patients with sleep disorders versus 3.5 for those without sleep disorders. At the same disability score, average healthcare costs were about US$1,254 for patients with sleep disorders versus US$766 for those without.

The impact of sleep disorders was even greater at higher levels of pain and disability. However, the study found no “moderating effect”—sleep disorders did not explain the increases in healthcare visits or costs for patients with higher pain or disability scores.

Low back pain is a very common condition and a major contributor to high levels of healthcare use and increased costs. Previous studies have suggested that sleep quality may contribute to outcomes for patients with musculoskeletal pain conditions, including back pain.

The new findings show that patients with diagnosed sleep disorders have higher healthcare use and costs for low back pain, independent of the effects of pain intensity and disability scores. Rhon and coauthors write, “The presence of sleep disorders is not often evaluated during the clinical management of low back pain, but could provide an important indication of risk for high pain-related healthcare use.” That may be especially important with new healthcare reimbursement models emphasising higher-quality, lower-cost care.

Rhon and colleagues call for further research to clarify how sleep disorders affect the outcomes of low back pain—including studies of patients with higher pain intensity and disability scores. They also discuss possible treatment implications, such as appropriate screening for disordered sleep earlier in the care management pathway. This also includes the need for clinical decision aids that improve management of disordered sleep for patients with back pain, as well as thresholds for referral to a sleep specialist.

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September 2019 | Issue 52

Interview

Profile

Tim Pigott A consultant neurosurgeon and the current president of EUROSPINE, Tim Pigott talks to Spinal News International about his career so far. Outside of his daily practice and society engagements, he is also involved in research into how we can use registry data to help improve patient selection for surgery. He has noticed “exponential growth” in the number of patients coming for treatment over the last 10 years, and remarks that one of the main challenges to spinal care is economics, positing that physicians must work with policy makers to ensure the needs of patients with spinal pain are heard. He advises young physicians to listen carefully to what their patients tell them, and to seek advice and support from colleagues when needed. An avid football fan, Pigott also discusses his interests and hobbies outside of the spinal world.

Why did you decide to pursue a career in medicine?

I was inspired by two friends of my parents who were doctors. They demonstrated the ability to apply science to patient management but with a great understanding of the individual’s needs and concerns. It is getting this balance right that can be the great challenge for medical practice.

What drew you to neurosurgery, and in particular spinal surgery?

As a very junior doctor I spent six months working for Professor Ted Hitchcock. He was an inspirational teacher, who always had time for the most junior member of the team. My interest in spinal surgery evolved from my interest in microsurgery and the management of intradural spinal problems, which has remained one of my main fields of work.

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

My first mentor was Jonathan Punt (paediatric neurosurgeon in Nottingham, UK). He was a hard task master but instilled in all the trainees the importance of listening to patients and attention to detail, something I have never forgotten. My mentor in spinal surgery has to be Gerry Towns (spinal neurosurgeon in Leeds, UK) who is a master of surgical technique. His emphasis on careful tissue handling, haemostasis and use of the microscope were all very important in my future career.

What is the main focus of your current research?

My current focus is registry data. Liverpool are a big user of Spine Tango with a database of over 11,000 cases, with excellent follow-up data. We are currently looking at ways to use this data for prognostic modelling to help improve patient selection for surgery. The challenge is to ensure accurate data and proper evaluation of that data to produce meaningful information. What this has meant in practice is a much better understanding of complications that matter to patients, the ability to look at our outcomes and benchmark these with other centres around Europe.

What is the most interesting piece of research you have read recently?

Rather than a piece of research I would recommend Being Mortal by Atul Gawande, it is a must read for all doctors. He explores the issue of age-related frailty and the importance of life still having purpose even in patients nearing death.

How have your research activities influenced your clinical practice, and vice versa?

I think academic rigour is really important in medical

practice, especially evidence-based medicine. This allows for a clear discussion with a patient about the potential options (including the non-surgical ones). Specifically, the registry data has allowed us to give patients a much clearer idea about the outcome of surgery and the complications as expressed by previous patients.

How has the field of spinal surgery changed since you started your career?

There has been an exponential growth in the number of patients coming for treatment, we have seen growth of almost 10% each year for the last 10 years. This is mainly due to the ageing population but also the change in what can be achieved and the more educated consumer. There has been an explosion of knowledge around deformity and sagittal balance. We now have much better instrumentation than when I started out in my career, especially for the cranio-cervical junction.

In your opinion, what are the most exciting developments in spinal surgery that we can expect in the next five to 10 years?

At the EUROSPINE 2017 meeting in Dublin, UK, we had an inspiring talk from Mark Pollock about the use of exoskeletons in paraplegics to enable walking. It is this and functional restoration with regeneration that will be the big developments in the next five to ten years. Spinal surgeons will need to keep abreast of these changes so that they are able to be involved in the management of these patients.

What do you think are the main challenges in the field at the moment?

Economics! Everyone knows that we have an ageing population with greater requirements for spinal interventions. Health resources are not infinite and it will require great effort to ensure that the group of patients with spinal pain have a voice. Margareta Nordin (former EUROSPINE president) and colleagues have demonstrated that this is a leading cause of disability worldwide and that we have to improve access to spinal services for all. Increasingly, governments and health insurers will demand evidence of efficacy and cost benefit for us to be able to undertake treatments. This makes a very strong case for the use of registry data to demonstrate the outcome of any spinal intervention.

What are the potential solutions?

Organisations such as ours need to engage with policy makers to make sure that the needs of patients with spinal pain are heard. We must demonstrate that our

The most difficult thing to teach is when not to operate but it is the most important part of decision making.” treatments are effective with proper outcome data, and also that what we do is cost effective. This does not just apply to surgery but to all aspects of spinal care.

What is your proudest career achievement to date?

When I see trainees who have come through our department being successful in other units around the world I always feel proud that we have been able to help

Issue 52 | September 2019

Interview

17

Fact File

(EDISC), which I attended and greatly enjoyed.

We are furthermore in the process of launching our new e-learning platform and our first blended education session will take place in November.

We have moved our Spine Tango service provider to Northgate who are well known for running the British Joint Registry. Our certification project for centres of Spinal Excellence has now fully launched. We have had a successful meeting last year in Barcelona, Spain, and an exciting Spring Speciality Meeting earlier this year in Frankfurt, Germany.

As a specialist in intra-dural surgery, what are the biggest challenges facing the field right now?

One of the biggest challenges in the field is the management of syringomyelia and chiari malformation. Over my career there has been some excellent work in this field to help understand the pathophysiology but we are still a long way from fully understanding the complex changes in cerebrospinal fluid dynamics.

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

The most difficult thing to teach is when not to operate but it is the most important part of decision making. Always apply your knowledge to your decision making and never forget to listen carefully to what the patient tells you. It is easy to become disheartened if your interventions do not turn out as you hope, this is when it is especially important to seek advice and support from colleagues.

Can you describe a particularly memorable case?

them learn and develop in their chosen field. Teaching the next generation is so important and is a duty for all of us. The best way to repay your own mentors is to try and do the same for your trainees.

You have been an active member of EUROSPINE for some time. What have you achieved over the past year as president?

EUROSPINE is a team effort and everything that has been achieved is by the excellent group of people around me. Besides the tremendous growth of our membership base and the ongoing success of our meeting activities, we have established the EuSSAB advisory board as a platform to bring all European national spine societies together to discuss core issues of common interest to the benefit of all members of any spine society in Europe.

Regarding our core activities we have had our first (and very successful) non-surgical diploma in Geneva

Most surgeons would agree that the memorable cases are often those where things do not go as expected.

However, a young girl of 16 came in having fallen off a bouncy castle. She was paraplegic with a T6 burst fracture, but with some retained sensation over the sacrum. We operated on her immediately to decompress the spinal cord and fix the fracture. When she transferred to rehab a week later she was beginning to move one big toe. She came back to clinic three months later and walked in on elbow crutches. She has since got married and had two children! Her determination to get better and prove everyone wrong was inspirational.

What are your interests and hobbies outside of spine?

Anyone who knows me will appreciate my support of Liverpool Football Club, it was a fantastic season for them and they won The Champions League which is the premier club tournament in Europe! I also enjoy hiking, classical music, playing the piano (badly), and gardening.

Qualifications

1992 Specialist Fellowship in Neurosurgery, Intercollegiate 1990 Doctor of Medicine, Nottingham, UK 1986 Fellowship Royal College of Surgeons, London, UK 1982 Bachelor Medicine and Surgery, Birmingham, UK

Current positions

Consultant neurosurgeon with a special interest in spinal surgery, The Walton Centre for Neurology and Neurosurgery, Liverpool, UK Postgraduate Tutor, The Walton Centre Chairman of Audit, The Walton Centre Leader of the implementation of the National Back Pain Pathway for Merseyside, Cheshire, and North Wales, UK Patient Reported Outcome Project (Spine Tango) leader, The Walton Centre President of EUROSPINE

Trauma experience

Past chair clinical governance for The North West Trauma Board Past board member of the Trauma Audit Research Network Past national chairman of Advanced Trauma Life Support (ATLS) Past ATLS tutor at The Royal College of Surgeons, London, UK

Previous society positions

Council member for The Society of British Neurological Surgeons Executive of The British Association of Spinal Surgeons Chair of education, membership, and Spine Tango for EUROSPINE

Publications (selected)

Herren C, Sobottke R, Mannion AF, et al. Spine Tango Contributors. Incidental durotomy in decompression for lumbar spinal stenosis: Incidence, risk factors and effect on outcomes in the Spine Tango registry. Eur Spine J 2017.

Zehnder P, Aghayev E, Fekete TF, et al. Influence of previous surgery on patient-rated outcome after surgery for degenerative disorders of the lumbar spine. Eur Spine J 2016;25(8):2553-62.

Al-Mahfoudh R, Mitchell PS, Wilby M, et al.

Management of giant calcified thoracic disks and description of the trench technique. Global Spine J 2016;6(6):584-91.

Patel A, Zakaria R, Al-Mahfoudh R, et al.

Conservative management of type II and III odontoid fractures in the elderly at a regional spine centre: A prospective and retrospective cohort study. J Neurosurg 2015;29(2):249-53.

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September 2019 | Issue 52

Global spine

New study offers first description of management and outcome of spinal trauma in East Africa

The first study to describe the management and outcomes of spinal trauma in East Africa was recently published in the Journal of Neurosurgery: Spine. First authors Andreas Leidinger and Eliana E Kim, senior author Roger Härtl (Weill Cornell Brain and Spine Centre, New York, USA) and colleagues, conclude that their results “provide strong support to implement evidence-based protocols for the management of spinal trauma”.

SPINAL TRAUMA IS a major cause of disability worldwide, and the burden is especially severe in lowincome countries, where hospital infrastructure is poor, resources are limited, and the volume of cases is high.

Currently, the authors note, there are no reliable data on incidence, management, and outcome of spinal trauma in East Africa.

The main objective of this study, therefore, was to describe, for the first time, the demographics, management, costs of surgery and implants, treatment decision factors, and outcomes of patients with spine

trauma in Tanzania.

Leidinger, Kim and colleagues report that due to the lack of referral hospitals, patients are admitted late after trauma, often with severe neurological deficit.

In addition, they found that surgery is performed but generally late in the course of the hospital stay and the decision to perform surgery and timing are heavily influenced by the availability of implants and economic factors such as insurance status.

Finally, they note that patients with incomplete deficits who may benefit most from surgery are not prioritised, even though their findings indicate that surgery may have a positive impact on patient outcome.

They suggest: “Further studies with a larger sample size are needed to confirm our results.”

Leidinger, Kim and colleagues included and analysed 180 patients in this study. They found that the mean distance from site of trauma to the surgical referral centre in Tanzania—Muhimbili Orthopaedic Institute (MOI)—was 278km, and the time to admission was on average 5.9 days after trauma. They note that young males were primarily affected, making up 82.8% of the total cohort.

On admission, 47.2% of patients presented with Abbreviate Injury Scale (AIS) grade A and the most common mechanisms of injury were motor vehicle accidents (28.9%) and falls from height (32.8%). Forty per cent of admitted patients underwent surgery, with the mean time to surgery being 33.2 days. Out of the patients who underwent surgery, 21.4% improved in AIS grade at discharge (p=0.03). Overall, the authors found that the only factor associated with improvement in neurological status was undergoing surgery (p=0.03) and shorter time to surgery (p=0.02).

The investigators describe the study as a retrospective review of

Global effort to address degenerative spine conditions in regions with high demand is “imperative” to reduce disability In a recent, award-winning study, 266 million individuals (3.63%) worldwide were found to have degenerative spine disease and low back pain annually. “Significantly,” the investigators note, “data quality is higher in high-income countries, making overall quantification in low- and middle-income countries less complete.”

They conclude that “a global effort to address degenerative conditions of the lumbar spine in regions with high demand is important to reduce disability.”

T

he paper, authored by Vijay M Ravindra (University of Utah, Salt Lake City, USA) and colleagues, was published in the Global Spine Journal in April 2018, and recently received a Best Paper Award from the journal.

While lumbar degenerative spine disease is a common cause of disability, the authors note that a reliable measure of its global burden does not yet exist.

Ravindra and colleagues therefore sought to quantify the incidence of lumbar degenerative spine disease to determine its overall burden across World Health Organisation regions and World Bank income groups.

The investigators found that out of

the 266 million individuals worldwide they found to have degenerative spine disease and low back pain each year, the highest and lowest estimated incidences were found in Europe (5.7%) and Africa (2.4%), respectively. They also found that, based on population sizes, low- and middle-income countries have four times as many cases as high-income countries.

In addition, spondylolisthesis was found in 39 million individuals (0.53%) worldwide, symptomatic disc degeneration was noted in 403 million (5.5%) individual, and 103 million (1.41%) individuals worldwide were estimated to have spinal stenosis annually.

Ravindra and colleagues used a meta-

prospectively collected data on spinal trauma patients in a single surgical referral centre (MOI) from October 2016 to December 2017. They collected general demographics and information on distance from site of trauma to the centre, AIS, time to surgery, steroid use, and mechanism of trauma and AOSpine classification and costs.

Surgical details and complications were recorded and the primary outcome was defined as neurological status on discharge. The authors analysed surgical outcome and determining predicting factors for a positive outcome.

The authors note some limitations of this study. They mention, for example, that its scope is limited to the pool of patients who survived long enough to eventually be referred to MOI and thus does not enable them to calculate the total number of spinal trauma patients in Tanzania or its absolute mortality and morbidity.

Furthermore, they did not collect information concerning type of transportation to MOI, “which limits out understanding of the characteristics and areas of coverage of medicalised transportation in Tanzania”.

On the significance of the study, the authors comment: “These results provide strong support to work with local surgeons and the hospitals in order to implement treatment protocols that prioritise ICU admission, haemodynamic monitoring, and early surgical management, especially of patients with incomplete deficits.”

They continue: “Education and more collaboration with surgical societies and academic groups dedicated to global surgery are also necessary. These efforts are currently underway but will also require healthcare-related changes that are beyond our direct influence, such as insurance coverage and availability and pricing of surgical implants.”

analysis to create a single proportion of cases of degenerative spine disease in patients with low back pain. Using this information in conjunction with low back pain incidence rates, they calculated the global incidence of individuals who have degenerative spine disease and low back pain, i.e. their neurosurgical relevance, based on the Global Burden of Disease 2015 database.

The authors remark that while numerous studies have quantified the incidence and prevalence of degenerative spine disease, the combination of sparse high-quality population-based data, competing disease definitions, and specific population samples, coupled

The results are necessary if we are to begin to plan a global public health effort.” with limited literature resulting from underdiagnosis and underreporting of lumbar degenerative spine disease in resource-poor settings, have hindered the ability to produce a global estimate.

Ravindra and colleagues recognise a few limitations of the present study.

Roger Härtl

They note that a topic this general “inherently is reported in populations that are non-uniform, making direct comparisons challenging.” In particular, combining epidemiological data across heterogeneous cohorts risks misrepresentation of disease volume.

In addition, they note that the “paucity” of epidemiological information from low- and middle-income countries likely results in the under-representing of these areas in the overall volume of degenerative spine disease and low back pain.

Finally, a large amount of the literature is focused on elderly, ageing populations. “This likely stems from the notion that degeneration implies an age relation, which is a misnomer that is highly prevalent in the literature,” the authors note.

More generally, the investigators note that additional studies should be undertaken to examine the burden to cervical degenerative disease, degenerative scoliosis, spinal cord injury, spinal infection, and rheumatological diseases that affect the spine “to obtain a more complete picture of the global burden of these diseases.”

Overall, the investigators conclude: “The tremendous amount of data found within the literature cannot possibly be summarised in a single study, but the results are necessary if we are to begin to plan a global public health effort.”

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September 2019 | Issue 52

Early onset scoliosis

CSRS and the evolving role of the scientific conference Alexander Vaccaro Comment & Analysis Alexander Vaccaro, outgoing president of the CSRS, talks to Spinal News International about the society’s goals, its key features, and what to expect from the 2019 annual meeting. He also reflects on the wider significance of the meeting, and how it continues to be “relevant” in its ever-changing role as a scientific conference.

SINCE THE CERVICAL Spine Research Society (CSRS) was founded in 1973, the goal of the society has been to carry out research and develop and exchange information on the cervical spine. While the goals of the CSRS have never changed, there has been an evolution of the scientific meeting over the last 50 years. In the 1980s, 1990s and early 2000s, one of the major reasons

for attending meetings was to obtain continuing medical education (CME) credits, and while this is undoubtedly still a reason that some participants attend a conference, many surgeons, particularly younger surgeons, are obtaining webbased CME credits. This change in preference has lead to a decrease in attendance at many scientific conferences, and has lead many societies to alter their

focus with more attention being paid to website content than scientific conference content.

This year’s meeting (21–23 November, New York, USA) will be comprised of 75 primary research abstracts that were selected from over 500 submissions.

These abstracts vary from comparing gold standard treatments for cervical disease to newer cutting edge treatments. Prior to the meeting, there is an instructional course

Societies must determine what their core mission is if they hope to remain relevant and thrive in the future.” lecture that will focus on the treatment of complex cervical spine pathology as well as the management of complications on Wednesday 20 November.

In addition to primary research, this year’s meeting will also have four symposiums that focus on current trends and controversial topics. One of these symposiums will focus on the athlete’s cervical spine. With an increased focus on the safety of sports such as American football, it is critical that spine care

New method for EOS treatment “may help to mitigate loss of correction” A study has outlined the potential benefits of a new method for surgically managing patients with early onset scoliosis (EOS). The investigators found that active apex correction (APC), instead of apical fusion in the SHILLA technique, remodulates the apex vertebra, which may in turn help mitigate loss of correction in the long term due to crankshafting or adding-on.

I

n this retrospective study, Aakash Agarwal (University of Toledo, Toledo, USA) and colleagues set out to determine if active remodulation in the apex of the curve is possible in scoliosis and kyphoscoliosis patients, using APC for guided growth.

The study included 20 patients with either scoliosis or kyphoscoliosis who underwent this modified SHILLA approach, where instead of apical fusion, APC was applied. In this altered technique, the most wedged vertebra was selected followed by insertion of the pedicle screws in the convex side of the vertebrae above and below the wedged one. The convex and concave heights of the wedged and control vertebrae were recorded at the time of surgery and at follow-up, both using computed tomography.

The investigators found that the wedged vertebra demonstrated on average a 17% increase in the proportion of concave to convex heights ratio, whereas the control vertebra did not show any relative change in the wedged vertebra heights at the follow-ups.

Besides potential benefit, they also note a few immediate benefits of the procedure, which include avoidance of risky osteotomies required to insert screws at the concave end of the apex, and more economical surgery—a result of putting two screws instead of six at the apex of the curve. “The latter is extremely important for countries with limited resources, Agarwal tells Spinal News International.

According to the investigators, the results of this

study “provide clinical evidence of reverse vertebral modulation at the apex of the curve in patients with scoliosis and kyphoscoliosis, when modifying the traditional SHILLA technique with APC”.

The investigators note that growth guidance technique using SHILLA is one of the two most widely used posterior-based growth friendly techniques for curve correction and halting the progression of deformity in children with scoliosis or kyphoscoliosis.

Weighing up the different techniques, Agarwal notes: “SHILLA has the advantage of being onetime surgery and is technologically less demanding compared with MAGEC rods. However, there are still two major disadvantages of using SHILLA: loss of correction at follow up and need for osteotomies, that has kept it in par with traditional distraction-based systems. Even to this day the countries with limited resources (where MAGEC rods are used less than 30% of times) are performing multiple consecutive surgeries using traditional growth rods, instead of SHILLA.” He therefore suggests that any modified SHILLA technique that could eliminate the loss of correction and complications related to the need for osteotomies on the concave side is “very desirable”. Based on the positive results of this study, Medtronic’s External Research Program (ERP) provided financial support to University of Toledo’s computational modelling and simulation team led by Vijay Goel and Anand Agarwal to perform further optimisation of reverse modulation in relation to APC approach.

providers have the resources available to guide treatment of both professional and recreational athletes. Currently there are no widely accepted recommendations for when it is safe to return to sports after a cervical spine injury, but the CSRS hopes to address this at the annual meeting.

Prior to the meeting, a survey will be sent out to CSRS members on their opinion on when it is safe to return to play after a cervical spine injury. Utilising a modified Delphi method at the annual meeting, recommendations for return to contact sports after cervical spine injuries will be determined. Through this consensus building approach, the CSRS hopes to establish guidelines that will allow for consistent and safe return to play for athletes around the world.

In today’s changing environment, the role and value of scientific conferences is changing. It is no longer enough to simply offer CME credits in a desirable location; instead, societies must determine what their core mission is if they hope to remain relevant and thrive in the future.

Fortunately, by sticking firmly to its goals of carrying out research and developing and exchanging information on the cervical spine, the CSRS continues to be one of the most relevant spine societies and scientific meetings.

Alexander Vaccaro is the president of the Rothamn Orthopaedic Institute in Philadelphia, USA, and has been an orthopaedic spine specialist for 25 years.

In another study conducted by the same group, and just accepted in Spine Surgery and Related Research, the official journal of the Japanese Spine Society, Agarwal and colleagues demonstrated similar correction and height sustenance between traditional growth rods and this modified SHILLA approach.

Their data is available in a recent letter to editor of Spine where Agarwal emphasises the impact that socioeconomic differences which exist between developed and developing countries have on the adoption of MAGEC rods. He notes: “The magnetic growth rod is at the least 65% more expensive, and at the most 310% more expensive than traditional growth rods in developing countries.” In addition to cost, the research group believes the MAGEC system needs further refinement, because both surgeons and US MAUDE have indicated a high incidence of failure with their non-invasive distraction mechanism.

Agarwal commented: “The technical failure could

There are still two major disadvantages of using SHILLA: loss of correction at follow up and need for osteotomies.” easily be that because we are over-distracting spine and putting the MAGEC rod under tremendous pressure, which as shown in our previous studies led to increased likelihood of rod breakage.”Agarwal concludes: “It appears that until the technical failure associated with MAGEC’s distraction mechanism is resolved, along with advent of better socioeconomics in countries with limited resources, APC provides a safer alternative to traditional SHILLA and traditional growth rods.”

Issue 52 | September 2019

Observed patterns of cervical radiculopathy differ from standard distribution in over half of patients

Observed patterns of cervical radiculopathy only followed the standard “Netter diagram” distribution in 54% of patients and did not differ by the cervical level involved in a recent study by Steven J McAnany (Hospital for Special Surgery, New York, USA) and John M Rhee (Emory University, Atlanta, USA). Their work recently appeared in the July 2019 issue of The Spine Journal.

M

cAnany and Rhee note that cervical radiculopathy is often thought to present with symptoms and signs in a standard, textbook, reproducible pattern as seen in a “Netter diagram”.

However, it was their impression that patients with cervical radiculopathy often do not present to clinic

Cervical radiculopathy with a textbook-like description of symptoms, and they wanted to investigate how often the actual presentation differed from the expected classic pattern. To date, they remark, no study has directly examined cervical radicular patterns attributable to single-level pathology.

The purpose of this retrospective study, therefore, was to examine cervical radiculopathy patterns in a surgical population and determine how often patients present with the standard textbook (i.e. Netter diagram) versus nonstandard patterns.

McAnany and Rhee included patients who had singlelevel radiculopathy with at least 75% improvement of preoperative symptoms following ACDF. Epidemiologic variables including age, sex, weight, body mass index, laterality of symptoms, duration of symptoms prior to operative intervention, and the presence of diabetes mellitus were collected.

Not infrequently, patients present with radicular patterns that simply do not fit the standard description.”

The investigators identified all patients with singlelevel cervical radiculopathy operated on between March 2011 and March 2016 by six surgeons. The observed pattern of radiculopathy was compared to a standard textbook pattern of radiculopathy that strictly adheres to a dermatomal map.

The observed pattern of radiculopathy at presentation, including associated neck, shoulder, upper arm, forearm, and hand pain and/or numbness, was determined from chart review and patient-derived pain diagrams.

The authors specify that the Fisher exact test

21

was used to analyse categorical data and Student t-test was used for continuous variables. In addition, a oneway ANOVA was used to determine differences in the observed versus expected radicular pattern and a logistic regression model assessed the effect of demographic variables on presentation with a nonstandard radicular pattern.

The investigators further report that when a nonstandard radicular pattern was present, it differed by 1.68 dermatomal levels from the standard (p<0.0001).

Neck pain—found in 81% of patients—was the most prevalent symptom and did not differ by cervical level.

Furthermore, in a logistic regression model, none of the demographic variables were found to significantly impact the likelihood of presenting with a nonstandard radicular pattern.

Based on the study, the authors state that surgeons must think broadly when diagnosing patients with cervical radiculopathy. According to Rhee, “Not infrequently, patients present with radicular patterns that simply do not fit the standard description.

For example, many patients with a C6 radiculopathy do not have symptoms radiating into the thumb. Often, the symptoms may be limited to the ipsilateral neck, shoulder, or upper arm.

Conversely, those with a C4 or C5 radiculopathy may sometimes get radiating pain into the hand. If we do not think broadly when evaluating such patients, we risk dismissing their symptoms as being inconsistent.”

John Rhee

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September 2019 | Issue 52

Conference coverage

Surgical intervention and sagittal alignment can influence postoperative frailty in cervical deformity patients Optimal correction of sagittal alignment and improving a patient’s functional capacity can significantly influence postoperative frailty resolution, according to a recent study by Peter Passias (NY Spine Institute, New York, USA) and colleagues. According to the authors, the CD-FI is an important tool in stratifying preoperative deformity patients and these findings quantified the improvement in postoperative frailty for cervical deformity frailty index (CD-FI) patients undergoing intervention. The results of this study were presented recently by co-author Edem Abotsi (NY Spine Institute) at the 19th Annual Conference of the International Society for the Advancement of Spinal Surgery (ISASS; 3–5 April 2018, Anaheim, USA).

THE INVESTIGATORS REPORT a correlation of improvement in radiographic and frailty component variables one-year post-surgical intervention. More

specifically, they found that frailty decreased at one year along with a significant change in 13/40 (33%) CD-FI variables and that an improvement in ability to read, and feeling tired or exhausted correlated the most with improvement in frailty.

Furthermore, they write that average frailty decreased from 0.44 (“severely frail” status) to 0.25 (“frail” status) one-year post-surgery. Additionally, of the 40 variables included in the index, 20/40 (50%) improved at oneyear, while 13/40 significantly improved. They note that the majority of the frailty drivers were patient-reported outcomes that measured improved functional status.

The authors begin by outlining that cervical deformity is a potentially severely debilitating condition that

encompasses a wide range of etiologies, including spondylosis, inflammatory arthropathy, trauma, infection, iatrogenic, neoplastic, congenital, and neuromuscular pathologies. As a result, they identify that identification and stratification of patients at risk of complications is vital.

The investigators mention that Miller et al recently developed a novel adult CD-FI which correlated increased patient frailty with longer hospital stays, higher complication rates, and an increased risk of nonhome discharge. According to Passias and colleagues,

Duration of preoperative radiculopathy symptoms associated with worse outcomes A new study suggests that a longer duration of preoperative radiculopathy symptoms in patients with degenerative cervical pathology is associated with worse health-related quality of life (HRQOL) outcome measures after 1–3 level anterior cervical discectomy and fusion (ACDF) surgery. The results were presented by co-author Dhruv Goyal (Rothman Orthopaedic Institute, Philadelphia, USA) at the 19th Annual Conference of the International Society for the Advancement of Spinal Surgery (ISASS; 3–5 April 2019, Anaheim, USA).

L

ead author Danial Tarazona (Rothman Orthopaedic Institute) and colleagues conclude that it is “important not to delay surgery in patients with degenerative cervical radiculopathy to optimise patient outcomes after ACDF”. They note that while a longer duration of cervical myelopathy symptoms has been associated with worse outcomes, there is limited data on the duration of radicular symptoms and outcomes. The purpose of this study was therefore to determine

the influence that duration of radicular symptoms has on HRQOL outcome measures.

The investigators describe the study as a retrospective analysis of prospectively collected HRQOL outcomes data involving adults with cervical radiculopathy treated with 1–3 level ACDF surgery. Patients with less than one year of clinical follow-up were excluded from the study. Once enrolled the cohort was divided into three groups: 86 were included in the group of patients

there are a few limitations of this index which prompted their current study. They mention in particular that it requires a total of 40 health variables to calculate and that it is unknown which of the variables have the greatest potential for change or are the primary drivers of postoperative change in frailty.

The objective of the present study was to determine the impact of corrective surgery on the CD-FI. The investigators further aimed to identify the drivers of postoperative frailty score and to determine which variables were modifiable and non-modifiable in response to surgical intervention.

Passias and colleagues describe the study as a retrospective review of a prospective, multicentre database of cervical deformity patients enrolled from 2013–2018. Those patients with complete baseline and one-year frailty scores were included in the study, while the exclusion criteria were defined as spinal deformity of neuromuscular etiology, and the presence of an active infection or malignancy.

The authors define cervical kyphosis as C2–C7 >10 degrees, cervical scoliosis as a Coronal Cobb angle >10 degrees, and a C2–C7 sagittal vertical axis of >4cm.

Thoracic slope-cervical lordosis mismatch (TS–CL >10 degrees, chin-brow vertical angle C8VA) was defined as >25 degrees.

The surgical data that were collected for the study included the number of levels fused, the surgical approach, decompression type (discectomy, foraminectomy, corpectomy, or laminectomy), and the osteotomy type (incomplete/complete facet, SmithPetersen osteotomy, and opening/closing wedge).

The investigators measured a number of global alignment parameters, including the sagittal vertical axis, regional spinopelvic parameters, such as pelvic incidence, lumbar lordosis, pelvic tilt, and the difference between pelvic incidence and lumbar lordosis. The final measurements related to regional and cervical alignment and included pelvic cervical kyphosis (C2–C7 angle >10 degrees, T1 slope angle subtended by superior T1 endplate and the horizontal), C2–C7 cervical lordosis (CL), T1 slope minus cervical lordosis (TS–CL), and C2–C7 sagittal vertical axis.

with less than six months of preoperative radicular symptoms; 61 in the group with six months to two years of preoperative radicular symptoms; and 69 in the group with over two years of symptoms.

Tarazona and colleagues measured various outcomes, specifically the SF-12 physical and mental composite scores, neck disability index, visual analogue scale neck and arm pain scores, and reoperation rates, and statistics were collected using one-way ANOVA (Turkey post-hoc testing), the Chi-Square test, and multivariate analyses.

The investigators found that in a cohort of 216 patients, there were no significant baseline differences in HRQOL outcome scores between the three different groups. Postoperatively, patients with a longer duration of radiculopathy symptoms had significantly worse outcomes in all of the HRQOL domains, with the only exception being the SF-12 mental component score. The authors’ multivariate analysis indicated that a longer duration of preoperative symptoms predicted worse outcome scores in all HRQOL categories tested.

The mean age of the patients was 51.9 years (range: 23–84), mean BMI was 29.4 (range: 18.8–54.9), and mean clinical follow-up was 16 months (range: 12–46.1).

“Patients should be counselled that

delaying surgery may result in less than optimal results,” Tarazona tells Spinal News International. “Specifically, cervical radiculopathy for more than six months results in less improvement in disability and pain. Furthermore, symptoms for more than two years was an independent predictor of worse HRQOL.” Commenting on the strengths of the study, Tarazona notes the extensive evaluation of several HRQOL outcome measures, which “allowed for a closer evaluation of the impact of duration of symptoms on pain, disability, mental health, and physical health. This allows for providers to give a more accurate representation of the outlook of their outcome.” In addition, he notes that the sample size was larger than prior studies and added to the “robustness” of their investigation.

“There were a few notable limitations,” remarks Tarazona, specifically the retrospective nature of the study, which meant it was subject to “all of the inherent biases” of this design, and the fact that the exact DOS was not available.

“While it was the authors’ intention to determine the exact DOS for every patient,” he comments, “this was not feasible in the patients with subacute and chronic symptoms, as they were often unclear on the exact start of the symptoms.”

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September 2019 | Issue 52

Market watch

Product News

First-of-its-kind treatment for young patients with scoliosis receives FDA approval Zimmer Biomet recently announced US Food and Drug Administration (FDA) approval for The Tether for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery.

The current surgical treatment for scoliosis is an invasive operation involving large incisions, extensive soft tissue disruption and restriction of spinal motion with metal rods inserted along both sides of the spine to secure and align the vertebrae. Surgeons have tirelessly searched for alternative nonfusion surgical approaches to address scoliosis without limiting the skeletal development of these patients who are active and still growing.

Zimmer Biomet’s anterior vertebral body tethering (AVBT) solution, The Tether, uses a strong, flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten the spine, while the inside of the curve is left free to grow. This growth modulation approach now offers select, well-indicated patients an option to achieve a straighter spine, without the limitations of spinal fusion.

Additionally, unlike fusion metallic rods, The Tether is positioned utilising an endoscopic minimally invasive approach through a few small openings between the ribs.

“Often growth in children with scoliosis results in curve progression.

With AVBT, that growth can be harnessed to gradually further correct the tethered portion of the spine,” notes Amer Samdani, board-certified neurosurgeon and chief of surgery for Shriners Hospitals for Children in Philadelphia, USA. “The Tether provides clinicians who take care of children with spinal curves another option for treatment. When utilised in the appropriately selected patient, the results are dramatic with respect to curve control and maintenance of a mobile spine.”

As an emerging treatment for a select patient population, The Tether is available through the FDA’s humanitarian device exemption (HDE) pathway. This approval marks the culmination of more than five years of cooperation between the FDA and Zimmer Biomet to bring innovative paediatric solutions to market and represents the first approval order for

a humanitarian use device in spinal paediatrics within the last 15 years.

Considering the recent removal (per FDA final rule) of many semirigid stabilisation systems that were historically used for AVBT, this solution arrives at a critical time for continuation of care.

“The Tether embodies Zimmer Biomet’s mission to improve the quality of life for people around the world. This collaboration demonstrates how a focused, shared purpose can fundamentally change the way we approach treatment of diseases like scoliosis,” said Jim Cloar, President of Zimmer Biomet Spine. “Working together, clinicians, the FDA and Zimmer Biomet have given surgeons an important fusion-less scoliosis treatment option for their pediatric patients. This procedure gives kids the best option for maintaining spine mobility and reaching their full potential.”

Collaboration will continue as Zimmer Biomet and the FDA finalise a new clinical study for The Tether to optimally monitor patient outcomes.

For the new study, Zimmer Biomet is excited to partner with the Harms Study Group, a worldwide cohort of surgeons with over 20 years of productivity who perform comprehensive, multicentre, prospective research studies focused on paediatric spinal deformity.

Spineology announces Duo Angled Instrumentation System

Spineology has announced the launch of the Duo Angled Instrumentation System. The angled instrumentation supplements the Duo Lumbar Interbody Fusion System and allows surgeons to efficiently address the L4–L5 disc space in cases where the iliac crest prevents collinear access to the disc space.

“Accessing the L4–L5 disc space when a high crest is present can be very challenging, especially when using a bladed retractor,” said John Malloy IV, Fort Lauderdale, USA. “Compared to the traditional lateral systems I have used in the past, the design of the Angled Duo Portal Tube and supporting Angled Instrumentation makes these cases much easier as it allows me to quickly access the disc space, perform an efficient thorough discectomy, and place an implant with significantly less

Spineology’s Duo Angled system

retraction of the soft tissue and neural structures.”

“Positioning bladed retractors in the optimal location to ensure the instrumentation enters the disc space at the proper angle is difficult in cases with a high crest,” said Kris Okumu, Daly City, USA. “The design of the Angled Duo Portal Tube makes the placement and proper positioning of the Portal Tube very simple, which has significantly reduced my OR time in these cases. I have also been very pleased with the design of the Discectomy and Insertion Instrumentation. The set enables me to quickly address all areas of the endplates and place and fill the Duo Implant in a very efficient manner, which adds additional time savings.”

The Duo System features the only implant on the market that combines PEEK, titanium, and graft containment mesh elements. The implant, which is filled with bone after insertion, creates a large, endplate-conforming graft pack that expands up to 30mm in width to maximise load-sharing and minimise point-loading. Once filled, the Duo Implant provides 70 percent more loadsharing surface area when compared to a 22mm width traditional lateral implant of the same length. These features are designed to reduce subsidence, improve spinal correction maintenance, and support a robust fusion.

In addition, the system significantly decreases the surgical access required to place the implant compared to traditional lateral systems. By minimising the neural and soft tissue retraction typically required in these surgeries, the company believes the Duo System will reduce the retraction-related neurologic deficits commonly associated with the lateral approach.

Medicrea announces FDA clearance of Tulip Genesis

The Medicrea Group announced today that it has received FDA clearance for Tulip Genesis, which completes its UNiD ASI platform technology.

With the FDA clearance of the Tulip Genesis, Medicrea completes its UNiD ASI platform by providing a top loading screw solution designed to integrate with UNiD ASI. According to a press release, Tulip Genesis is a state-of-theart comprehensive top loading screw system that competes with any screw system on the market offering solutions for both degenerative and complex deformity cases.

Medicrea’s implant database integrated within the UNiD Hub now includes: IB3D, a selection of 3D-printed patient-specific interbody cages; UNiD Rod, a patient-specific rod industrially pre-bent to precisely match the optimal individual surgical simulation; Pass LP, a modular screw system; and Tulip Genesis, a top-loading screw system.

Medicrea’s proprietary UNiD ASI technology is a comprehensive suite of solutions comprising services and products designed to help surgeons improve their patient’s outcomes.

Medicrea Tulip Genesis

By leveraging artificial intelligence and the latest clinical research, the platform enables the surgeon to plan cases preoperatively. The artificial intelligence (AI) embedded within the platform allows a surgeon to visualise the compensatory mechanisms above and below the instrumented spine that will most likely occur based on their surgical plan.

This technology offers solutions designed both for complex deformity and degenerative applications. The combination of AI with this product offering makes Medicrea the only manufacturer able to streamline inventory required to operate as well as provide patient-specific devices, through intelligent preoperative surgical planning.

“The combination of big data and patient-specific care is the new frontier,” says Chris Ames, director of spinal tumour and spinal deformity surgery at UCSF Medical Center, San Francisco, USA. “Medicrea’s technologies are specifically developed to that effect.

They help surgeons better manage the entire clinical workflow, providing them with targeted relevant data, to help them better analyse and plan, leading to improved clinical results. Through the power of data collection and machine learning, a unique capability is created, allowing for a continuous cycle of improvement.”

The Medicrea’s UNiD Lab team of biomedical engineers can more efficiently generate comprehensive surgical plans, using outcome-centred predictive modelling algorithms to optimise surgical strategy. These documented UNiD surgical plans also allow the operating room staff to clearly anticipate when each implant will be needed by the surgeon. This is a critical combination as it streamlines the OR workflow with precise preselected implants and alignment of staff to the patient specific surgical plan and as it makes the surgery safer for the patient by reducing the chances for errors.

Denys Sournac, president and CEO, concludes: “To date, we have performed more than 4,000 cases using the UNiD ASI technology, with a strong and continuous adoption rate in the US of +47% since the beginning of the year.

With the adoption of the UNiD ASI technology accelerating, Medicrea created a unique opportunity for a pullthrough effect by offering surgeons a complete solution of implants. Tulip Genesis completes Medicrea’s portfolio to achieve full pull-through and incremental revenue.”

Issue 52 | September 2019

NuVasive launches Pulse integrated technology platform

NuVasive has announced the launch of its Pulse integrated technology platform. According to a press release, “Pulse is the first, single platform to include multiple technologies designed to help surgeons adopt more efficient, less disruptive surgical approaches in all spine procedures.”

Engineered to improve workflow, reduce variability and increase surgical reproducibility, “Pulse addresses a broader range of clinical challenges in the operating room (OR) compared to any other enabling technology in the spine market,” the press release continues.

The Pulse platform combines neuromonitoring, surgical planning, rod bending, radiation reduction, imaging and navigation functions, with extensible capabilities to enable increased surgical efficiencies in the OR. These integrated technologies are designed to improve a surgeon’s ability to utilise minimally invasive surgery (MIS) techniques, which have been shown to reduce blood loss, hospital stays and result in less operative morbidity compared to open spine surgery.

“NuVasive’s Pulse platform provides an unmatched surgical experience due to its responsive and optimised workflow features,” said Juan Uribe, chief of the division of spinal disorders at Barrow Neurological Institute

Market watch (Arizona, USA). “The benefits of the surgeon experience by anticipating user advanced navigation and imaging, needs and fusing these technologies coupled with neuromonitoring, allow to create a seamless, optimised OR for optimised outcomes for patients, workflow, while addressing a broad while gaining impactful efficiencies for range of clinical challenges. This is my OR staff and hospital system.” a pivotal step in our strategic vision NuVasive completed to deliver end-to-end limited clinical release solutions that enable testing of the Pulse predictable clinical and platform, providing economic outcomes in initial validation that spine surgery.” its structural design supports broad clinical Pulse platform utility throughout the hardware entire surgery, and is and software useable in 100 percent modules of spine surgeries, The Pulse platform from fusions to includes the following complex corrections. enabling technologies, Its independent device with a modular access allows OR staff architecture allowing to simultaneously surgeons and hospitals view the technologies’ the flexibility to meet imaging and insights their needs in all spinal in real time and in cases: parallel. In addition, 1) Two- and threethe open and modular dimensional-imaging architecture of the and navigation: Image Pulse system allows transferring for both for flexible technology 2D- and 3D-imaging that Pulse (NuVasive) packages. combines novel camera, “The Pulse platform is uniquely array and workflow technologies to engineered to equip surgeons with improve line of sight, ease of use and a single platform of integrated surgical efficiency in the OR. Through technologies necessary to perform all NuVasive’s Spine Precision Partnership spine surgeries, including minimally with Siemens Healthineers, Pulse invasive approaches,” said J Christopher leverages the Cios Spin cutting-edge 3D Barry, chief executive officer of mobile C-arm.

NuVasive. “Pulse provides an intuitive 2) Surgical planning with integrated

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global alignment (iGA): Preoperative planning software that incorporates alignment parameters, implant integration, surgical modeling and other tools to help create a reliable plan prior to stepping into the OR. iGA is the only system on the market able to intraoperatively assess the surgical approach and effects on spinal alignment through real-time insights.

3) Neuromonitoring: Automated nerve detection system with standardized setup and clinically validated alerts that help reduce variability and allow for faster interpretation of neural information.

4) Smart imaging with radiation reduction through LessRay: Imaging system designed to take low-quality, low-dose images and improve them to look like conventional full-dose images.

LessRay significantly reduces exposure to radiation for everyone in the OR by as much as 80 percent compared to standard fluroscopy.

Rod Bending with Bendini: Spinal rod-bending technology used to create patient-specific rods, which are bent exactly to implant locations, expediting manual rod manipulation through computer-assisted bend instructions without leaving the OR. The Pulse platform features extensible capabilities for robotics and smart tools and the company plans to unveil its spine robotics module at the North American Spine Society 2019 Annual Meeting (NASS; 25–28 September, Chicago, USA).

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September 2019 | Issue 52

Market watch

Product News SeaSpine announces launch of Mariner Outrigger Revision System

SeaSpine has announced the limited commercial launch of the Mariner Outrigger Revision System. Mariner Outrigger is an implant system providing surgeons a high level of versatility for multiple revision applications.

As an adjunct to the Mariner Posterior Fixation system, Mariner Outrigger includes a variety of options to effectively revise and extend previous fusions. The system offers a comprehensive implant and instrument offering, including several differentiated implant technologies, in a single tray that reduces the overall volume of product required to support complex cases.

“Through the launch of the Mariner Outrigger Revision System, SeaSpine is expanding the applications of its modular Mariner platform to address more complex cases,” stated Dennis Cirino, senior vice president, Global Spinal Systems. “This demonstrates our continued commitment to deliver worldclass surgical solutions to our surgeon customers in the growing revision market.”

“Mariner Outrigger is designed to deliver versatility and simplicity in revision spine and deformity surgery,” stated Daryl Sybert, orthopaedic surgeon at Mount Carmel, New Albany, USA. “It improves operative efficiency through streamlined instrumentation and implants in a reduced number of trays. Combined with the strength and versatility of Mariner, I have a high level of confidence when addressing my revision surgeries.”

The launch of the Mariner Outrigger Revision System is one of several complementary systems that will expand the applications of the Mariner Posterior Fixation System. SeaSpine expects to commercialise additional application-specific systems that expand the procedural application of its modular Mariner platform, including the planned launch of a minimally invasive system before the end of the third quarter of 2019.

Implanet granted US patent for Jazz Lock technology

Implanet has announced that its Jazz Lock technology, which is an integral part of its Jazz solutions platform, has been granted a patent in the USA. A major component of the broadest range of band products on the market, Jazz Lock is a multipurpose implant designed to treat degenerative spine disorders. Thanks to its locking mechanism requiring no rod fixation, its use with a Jazz Band polyester braid allows surgeons to shorten and simplify the surgical procedure by eliminating two steps used in traditional systems:

Industry News locking screws and connecting rods.

Since its launch, Implanet has sold more than 1,700 Jazz Lock devices, mainly for the treatment of degenerative spine disorders.

The new patent in the USA, a strategic and competitive market, is a valuable addition to Implanet’s Jazz platform patent portfolio. The Jazz Lock innovative locking mechanism, which requires no rod fixation, is an integral part of Jazz Cap, a comprehensive, proprietary solution used to secure screws in poor quality bone, as required in 10–30% of vertebral fusion cases in adult patients.

Implanet CEO Ludovic Lastennet said: “We are continuing to execute our development strategy, in which protecting our innovations is a top priority. Protecting the Jazz Lock intellectual property is crucial, as most of our future developments, including the Jazz Cap, will leverage this technology. Along with our partners, we expect that Jazz Cap coupled with Jazz Lock will become the optimal

Implanet’s Jazz Lock

alternative to cement augmented pedicle screws. The full-scale launch of this technology is scheduled for September, when a global presentation will be given at the annual meeting of the North American Spine Society in Chicago, USA [NASS; 25–28 September].”

Centinel Spine announces IDE approval of two different ProDisc C devices

According to a press release, Centinel Spine has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a two-level clinical trial with two different ProDisc C Anterior Cervical Total Disc devices— ProDisc C Vivo and ProDisc C SK. The clinical trial will compare the ProDisc devices with an approved total disc replacement (TDR) product as a control in order to validate their safety and effectiveness. The ProDisc C Vivo product has been used since 2009 and is the most frequently implanted total disc replacement outside the USA. The ProDisc C SK implant is a variation of the ProDisc C Nova device, an implant successfully used outside of the USA since 2010. The company plans to begin the clinical trial immediately in multiple centres across the USA.

Cerapedics announces expansion of Colorado headquarters

Jon Serbousek to become Orthofix CEO

Orthofix Medical recently announced that it has named Jon Serbousek as president of its Global Spine business effective 5 August, 2019, and the successor to Brad Mason, the company’s retiring president and CEO, to be effective 1 November, 2019.

An executive with more than 30 years’ experience in the medical device and biotech industries, Serbousek served in several leadership positions at Biomet, including worldwide president of Biomet Biologics, worldwide group president of Orthopedics, and president of US Orthopedics. Prior to joining Biomet, he held various general management positions within Medtronic including worldwide division president, Spine, worldwide vice president and general manager of Biologics for their Spine and Biologics business. Additionally, Serbousek spent 13 years with DePuy Orthopedics, a Johnson & Johnson company where he served in numerous roles of increasing responsibility, including the vice president of Marketing and Product Development and as vice president of Spinal Operations.

“Jon’s expertise and proven track record are perfectly aligned with our business composition and make him an exceptional choice to lead the company as president and CEO,” said Brad Mason, Orthofix president and CEO.

Fusion Robotics device

Cerapedics has announced the expansion of the company’s headquarters located in the Denver metropolitan area. Over the past 18 months, Cerapedics has grown from 16 to 44 employees in Colorado and is increasing its facility from 14,000 to 24,000 square feet to accommodate further expansion through the end of 2019. In addition, Cerapedics is expanding its global workforce from 32 to 73 employees worldwide.

“We are excited to grow our Colorado footprint and bring more jobs and career opportunities to the Denver area,” said Glen Kashuba, CEO of Cerapedics.

“This expansion allows us to further control our value chain by relocating our distribution activities to our corporate headquarters. We now have the potential to double our headcount across key administrative, operational and sales support departments to meet the growing demand for i-FACTOR peptide enhanced bone graft and drive the business for years to come.”

In 2008, Cerapedics began commercial activity of i-FACTOR in the international markets, and then from 2016 it was commercialised in the USA. i-FACTOR is a drug-device combination that accelerates new bone formation in patients with degenerative disc disease.

It is in a new category of bone graft technology and is one of only two drugdevice combination products approved by the US Food & Drug Administration (FDA).

To further grow its product portfolio and support the company’s commitment to enhancing the science of bone repair, Cerapedics is currently enrolling patients in an investigational device exemption (IDE) clinical trial evaluating the safety and efficacy of the nextgeneration P-15L peptide enhanced bone graft in transforaminal lumbar interbody fusion (TLIF) surgery.

Fusion Robotics closes financing to advance spinal robotics platforms

Fusion Robotics has announced the closing of a financing round for an undisclosed amount with lead investment by Alex Lukianov (Lukpartners) and Kevin Foley. The proceeds will be used to ready the company’s spinal robotics platform to obtain regulatory clearance and to prepare for commercialisation.

The platform is an integration of technologies from Interventional Systems (Wattens, Austria) and Practical Navigation (Boulder, USA). Fusion Robotics’ CEO Brad Clayton, says, “The Fusion Robotics platform has a small footprint and is simple, cost-effective and scalable” which differentiates the system from other spinal robots.

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September 2019 | Issue 52

Market watch

Clinical News First patients treated in Japanese clinical trial of cell therapy for DDD

DiscGenics today announced the first patients have been treated in its Japanese safety study, a clinical trial of IDCT for mild to moderate degenerative disc disease (DDD). The treatments took place at Tokai University School of Medicine in Kanagawa, Japan, led by Daisuke Sakai, associate professor at the

treatment cohorts: low dose IDCT (n=15), high dose IDCT (n=15) and sham (n=8).

Each subject will receive a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc.

Following treatment, subjects will be observed and evaluated for a period of six months, with a six-month extension period.

DiscGenics IDCT injection

Department of Orthopaedic Surgery and the study’s principal investigator.

IDCT is a homologous, allogeneic, injectable cell therapy that utilises biomedically engineered progenitor cells, known as Discogenic Cells, that have been derived from intervertebral disc tissue to offer a non-surgical, potentially regenerative solution for the treatment of mild to moderate DDD. This prospective, randomised, double-blinded, sham-controlled study is designed to evaluate the safety and preliminary efficacy of IDCT at two dosage levels in subjects with singlelevel, symptomatic lumbar DDD, a major cause of chronic low back pain.

“I am excited to be participating in the clinical evaluation of IDCT as a potential cell therapy to treat degenerative disc disease,” said Sakai.

“I am encouraged by my preclinical observations of IDCT’s human Discogenic Cells in a canine disc degeneration model that demonstrated the ability to stop disc height degeneration while improving the structure of the intervertebral disc.

If we can achieve similar results in human subjects, the result could be reduced pain and disability associated with DDD.” Initiation of this trial was supported by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval of a Clinical Trial Notification (CTN) application for IDCT, announced in the fourth quarter of 2018.

The trial will take place in six centres across Japan and will enrol 38 subjects.

Those who meet the eligibility criteria will be randomised to one of three

Relievant announces publication of Level I INTRACEPT study

Relievant Medsystems recently announced the publication of the Level I INTRACEPT Study results in The Spine Journal. The INTRACEPT Study is a Level I, randomised, multicentre trial comparing the Intracept Procedure to non-surgical standard care. Based on the results of a prespecified interim analysis, the independent Data Management Committee recommended investigators stop study enrolment early and crossover the control arm patients due to clinically and statistically superior outcomes in patients treated with the Intracept Procedure.

The interim analysis included 104 patients, 51 in the Intracept arm and 53 in the standard care arm, enrolled at 20 sites in the USA. The published results demonstrated a highly significant difference between the Intracept arm and the standard care arm for the primary endpoint and all secondary endpoints.

Key results from the study include: Intracept treated patients demonstrated a 20.9 point greater improvement in Oswestry Disability Index (ODI) compared to standard care (p<0.001) for the primary endpoint of mean reduction from baseline to three months The mean Visual Analog Scale (VAS) for low back pain was also reduced by 2.44cm more in the Intracept treatment arm as compared to the standard care arm (p<0.001) 74.5% of patients in the Intracept arm reported a minimal clinically important difference of ≥10-point ODI reduction

and 62.7% reported a ≥20-point ODI the natural course of this disease. reduction at three months, both highly We are seeing an extensive number significant compared to standard care of patients continually meeting child (p<0.001) motor development milestones,” Twice the number of said Darryl De Vivo, patients in the Intracept Sidney Carter professor arm reached a minimal of Neurology clinically important and Paediatrics, difference of ≥2 Columbia cm reduction in University Irving VAS at 72.5% Medical Center in compared to New York, USA. 34.0% of patients “Nusinersen is in the standard care setting patients on a arm (p<0.001). path toward survival, There were no greater mobility and serious device or deviceindependence from the procedure related start of treatment, which is events reported. helping improve outcomes for “Patients with chronic low Relievant patients of all ages.” back pain have limited options Results from NURTURE, beyond standard conservative care. an ongoing, Phase 2, open-label study These results confirm that the Intracept of 25 pre-symptomatic patients with Procedure is a highly effective new SMA (most likely to develop SMA Type treatment option for these patients,” 1 or 2) who received their first dose said Jad Khalil, orthopaedic spine of nusinersen before six weeks old, surgeon, William Beaumont Hospital, demonstrated results not before seen Royal Oak, USA. “The outcomes of in comparison to the natural history of the INTRACEPT Study build upon SMA. As of March 2019: the Level I SMART Trial results.

100% were alive without a need for Collectively, there are now two large, permanent ventilation. high-quality randomised control trials The median age of the study demonstrating the effectiveness of this participants was nearly three years old. treatment for patients with chronic The majority of untreated patients with vertebrogenic low back pain and Modic SMA Type 1 never reach their second Type 1 or 2 changes.” birthday without permanent ventilation.

“The INTRACEPT Study results 100% of the infants were sitting provide compelling data comparing independently, in comparison to the the Intracept Procedure to currently natural history of this disease where no available, real-world treatment patients with SMA Type 1 would be able options,” said Kevin Hykes, CEO to do so and patients with SMA Type 2 of Relievant Medsystems. “These would need assistance. results complement the recently 88% of the infants were walking published 24-month results from the independently with many of them doing Level I SMART Trial and provide an so in the normal timeframe for a toddler. unparalleled body of Level I evidence In the natural history of SMA, patients supporting the effectiveness and with SMA Type 1 or Type 2 are never durability of the Intracept Procedure.” able to walk independently.

Patients were approaching the Biogen announces new data maximum mean score of 64 on the providing further evidence CHOP INTEND measure of motor for SPINRAZA (nusinersen) function­—63.4 for patients with 3 SMN as a treatment for SMA 2 copies (n=10) and 62.1 for those with Biogen today announced new results 2 SMN 2 copies (n=15), demonstrating from the NURTURE study, adding the impact of early treatment. data to the longest study of spinal Nusinersen demonstrated efficacy muscular atrophy (SMA) in preup to nearly 4 years, with participants symptomatic infants (n=25). These continuing to make progress and data reported, after up to 45.1 months showing no signs of loss of motor of analysis, continue to demonstrate function. efficacy and safety in patients treated Nusinersen was well-tolerated with pre-symptomatically with nusinersen in no new safety concerns identified after comparison to the natural history of up to nearly 4 years of treatment. this disease. These new data also showed that patients treated with nusinersen had continuous improvement in sitting and walking independently, with the overwhelming majority of patients achieving motor milestones in a normal timeframe.

These data are being presented at the Cure SMA Annual Conference in Anaheim, USA (28 June 28–1 July) and the 5th Congress of the European Academy of Neurology (EAN; 29 June–2 July, Oslo, Norway).

“These study results demonstrate the durable impact of pre-symptomatic, proactive treatment on transforming SPINRAZA (Biogen)

Issue 52 | September 2019

Market insights

Medtronic buys Titan Spine in bid to provide the “most comprehensive portfolio” Medtronic has completed its acquisition of Titan Spine, which has a range of interbody fusion devices that feature unique surface technology. A press release reports that the acquisition provides opportunities to bundle interbodies, screws, rods, biologics, and “enabling” technologies, such as navigation, to develop “integrated procedural solutions”. It adds that Titan Spine will now become part of Medtronic’s Spine division, which in turn is part of its Restorative Therapies Group.

TITAN SPINE’S RANGE of “Endoskeleton” interbody fusion devices are coated with either the company’s proprietary nanoLOCK surface technology or with its “original surface” technology.

The Titan Spine website reports that the original surface technology was designed to encourage bone growth “by interacting with the patient’s cells to activate their natural bone growth mechanisms”.

It adds that the technology “was the breakthrough that sparked the entire surface technology revolution, leading to our proprietary combination of surface textures that altered the interbody fusion landscape forever.” NanoLock, according to the website, was designed to provide “even better” fusion than the original

technology “by incorporating a significantly greater amount of the microscopic and nanoscopic features that are found on natural bone”.

Jacob Paul, the senior vice president and president of Medtronic’s Spine division, says that the acquisition of Titan Spine will bring the two companies together to “provide best-in-class solutions for spine surgeons’ biggest challenges.” He adds that Titan Spine has “pioneered the spine implant surface technology category over the past several years”, commenting: “We feel that surface-enhancement titanium implants combined with our comprehensive biologics portfolio can have positive impact on patient outcomes in spinal

procedures.”

According to Paul, the acquisition is also part of “an exciting phase of innovation and growth” at Medtronic.

He notes that, last year, the company bought Mazor Robotics—a developer of a robot-assisted spinal surgery system.

Subsequently, in January this year, Medtronic launched the Mazor X Stealth Edition onto the US market. At the time of the launch, Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic, said: “As part of our surgical synergy strategy, we believe Mazor X Stealth Edition will accelerate the advancement and adoption of robotic-assisted and navigated surgical technologies in spine. Medtronic is

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committed to transforming the future of spine care by offering procedural solutions that integrate implants, biologics and enabling technologies like navigation, 3D imaging, robotics and powered surgical tools.”

According to a press release, the acquisition of Titan Spine is expected to be “immaterial” to Medtronic’s fiscal 2020 adjusted earnings per share and is also expected to meet Medtronic’s long-term financial metrics for acquisitions. Paul observes that the purchasing of Titan Spine and Mazor Robotics, as well as the launch of its Infinity Spinal System in September 2018, cements the company’s leadership in the spinal market and enables them to offer customers the “most comprehensive portfolio in the spine industry”.

However, Medtronic is not the only major medical device company that has made an investment in the spinal market recently. In June this year, Boston Scientific completed its acquisition of Vertiflex—a company that developed and commercialised the minimally invasive Superion indirect decompression system for the management of lumbar spinal stenosis.

BIBA Briefings

BIBA Briefings is an online platform (www.bibamedtech.com/biba-briefings) that gives in-depth analysis of the latest market intelligence from BIBA MedTech Insights (www.bibamedtech.com). It also reviews the latest technology news and pipeline developments.

For editorial enquiries, please contact Dawn Powell: dawn@bibamedical.com For sales enquiries (including BIBA MedTech Insights), please contact Merveille Anderson: merveille@bibamedical.com

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Market watch

September 2019 | Issue 52

Clinical News New clinical data demonstrates the versatility of Globus Medical’s ExcelsiusGPS

Globus Medical has announced the results of a clinical study that evaluated the versatility of ExcelsiusGPS robotic navigation system compared to traditional pedicle screw placement techniques. Published in the Journal of Robotic Surgery, “Robotic-assisted navigated minimally invasive pedicle screw placement in the first 100 cases at a single institution,” demonstrated a 99% screw placement success rate with no malpositions or postoperative returns to the OR related to screw placement.

The study explored how the ExcelsiusGPS advanced navigated robotic technology combines the ability to use three imaging workflows (preoperative CT, intraoperative CT, and fluoroscopy) with navigation and guidance to accurately place pedicle screws with real-time feedback.

A total of 562 lumbar pedicle screws were placed across six vertebral levels during 55 single-position lateral, 16 anterior, and 29 posterior interbody fusion cases, highlighting the versatility of the system for various approaches.

Interbody placement was performed manually.

“This study highlights the system’s

capability to transform the way lateral surgery is performed. ExcelsiusGPS enables surgeons to perform minimally invasive screw fixation with the patient remaining in the lateral position compared to traditional lateral approaches where the patient is intraoperatively repositioned prone,” says Kade T Huntsman, orthopaedic spine surgeon at Salt Lake Orthopaedic Clinic (Salt Lake City, USA).

“Eliminating patient repositioning may lead to increased operational efficiency, cost savings, and improved patient outcomes.”

Majority of women unaware that SI joint issues a leading cause of chronic LBP after pregnancy Results of a recent survey of 1,000 women (age 35–60) conducted by SIBone found that 86% of respondents are unaware that sacroiliac (SI) joint dysfunction is a leading cause of chronic lower back pain for women over 35 who have been pregnant.

Studies have shown that the SI joint is the source of pain in 15–30% of patients with chronic lower back pain and two-thirds of people impacted by the condition are women. The survey revealed that 65% of respondents experience lower back pain and nearly

30% have been dealing with pain for more than ten years. Yet, fewer than one in five women had spoken with a doctor about the possibility of the SI joint being a cause of lower back pain.

The survey found that 87% of respondents who suffer from chronic lower back pain have seen up to four doctors for treatment. Survey respondents also indicated a number of quality of life struggles due to their lower back pain: ● 43% have difficulty standing up straight, walking or moving from the standing position to the sitting position ● 43% have difficulty sleeping ● 36% struggle with anxiety or depression ● 47% have experienced unwanted weight gain ● 39% are unable to engage in physical activity ● 75% want treatment options that will allow them to stop using over-the-counter medication, prescription drugs or opioids “We are dedicated to developing minimally invasive treatment options to help patients find relief from chronic back pain due to SI joint dysfunction.

Quality of life is greatly impacted for those suffering with chronic SI joint pain. We aim to provide programs that both educate people with chronic SI joint pain and provide innovative treatment options that allow them to get back to enjoying their daily lives,” said Jeffrey Dunn, president and CEO of SI-Bone. “Findings from this survey

reinforce the impact this condition has on women and the need for increased education and awareness to support proper diagnosis and treatment.”

About the survey

The survey of 1,000 women (35+) from across the United States was sponsored and conducted by SI-Bone in June 2019 to better understand awareness of SI joint dysfunction as a serious health issue for women who struggle with lower back pain as well as to learn about women’s experiences with treatments available for lower back pain. Of those queried, over one-third had been living with back pain for 10 or more years.

About the product

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.

This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit.

Calendar of events 18–21 September Scoliosis Research Society (SRS) 54th Annual Meeting & Course Montréal, Canada www.srs.org/am19

24–28 September EANS 2019 Dublin, Ireland eans2019.com

25–28 September NASS Annual Meeting Chicago, USA

16–18 October EUROSPINE 2019 Helsinki, Finland

31 October–2 November SMISS Annual Forum 2019 Las Vegas, USA

nassannualmeeting.org

www.eurospinemeeting.org

smiss.org/annual-forum-19

11–12 October Fundamentals of Spine Surgery for Residents and Fellows Burr Ridge, USA

27–31 October 10th Interdisciplinary World Congress on Low Back & Pelvic Girdle Pain Antwerp, Belgium

6–7 December 5th Annual International Spinal Deformity Symposium (ISDS) New York, USA

23–26 January Spine: Base to Summit Vail, USA 27 April–1 May SpineWeek 2020 Melbourne, Australia www.spineweek.org

www.worldcongresslbp.com

Issue

March

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bar multiple lum Fusion of associated with segments joint pain sacroiliac App

res has been cral procedu d online in Spine, res. and lumbosa publishe these procedu in lumbar in a study s involved c joint pain back pain following of segment of sacroilia low incidence l cause of The number affect the a potentia shown to the symptom as g confirmin failure oting published five rates of between for lumbar and 30% al spinal fusion and lumbosacr well as the s, as procedure of these frequency increasing of researcher

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: Chris Bono

Q&A

Page 16

lski: Marek Szpa

Profile

Page 12

joint fusion Sacroiliac

Feature

Page 14

ps Motion trum SS NA fusion at debate

s a team surgeries, Kousei Medical from the Akita Japan) performed Center (Akita, analysis of ive the spinal a retrospect to determine common ive patient data t of many of postoperat res designed The treatmen primary causes fusion pain. by procedu more joint Walters Kluwer) conditions motion or by the subject of multiple sacroiliac (E Unoki, joint pain asserted that to preserve fusion was the The team Annual with sacroiliac noted sacroiliac of 28 patients at the 30th sacrum is conventional authors have potential candidate when the Fusion levels of debates American Spine , fusion as a symptom a series pain of a lumbar joint pain of the North October, Chicago the authors of low back fused as part could be more Meeting al fusion, 14–17 for the cause hal of the joint , it is lumbosacr lumbar fusion. procedure joint pain that sacroiliac 201 Society (NASS;by Scott Blument following sacroiliac patients discovered from Plano, USA. likely that in 20 of the of multiple USA), chaired Using data lumbar or Institute, the fusion pain occurred patients (10%) “We related to Texas Back who had undergone at the Akita of the spine. multiple lumbar fusion 61 lumbosacral al fusion segments and of the fusion of lumbosacr June 2006 and eight Whilst this ierce D Nunley consider that restrict the motion (13.1%). centre between researchers al can patients bar the (Spine Institute segments of towards lumbosacr or thoracolum June 2009, did trend of Louisiana, d the incidence of the lumbar authors observed ly depending investigate associated . fusion, the , USA) and joint pain spine considerab difference Shreveport of involved sacroiliac of floating no significant es Abitbol incidence fixed and on the number consequently Jean-Jacqu ip with both at Spine Group, When comparing the relationsh spinal segments, at the sacroiliac among fusion (California segments fusion, and stress USA) the symptom authors number of increasing San Diego, levels, the surgery and between the ly more authors wrote. the task of different in the fusion joint,” the that significant were given of literature involved joint pain. body a fusion treatment discovered underwent Citing sacroiliac of load debating the the rate of (20% a transfer two-level and sixty-two patients who reporting by the Nunley of a case of more segments Two hundred not experienced segments Pierce D of of three or had onto lower at ≥4) developed cervical herniated either fused levels patients who sacroiliac joint pain at 3, 22.5% sacroiliac joint pain. straightening of ve segment Of nucleus pulposescervical ive preoperati case for in adjacent postoperat in the study. argued the the spine reviewed lumbar with an anterior fusion were included 201 underwent procedure.

The authors a and the fusion disease following speculate discectomy to determine than 60 these patients, and 61 also or with authors literature that behind Citing more results, fusion fusion, The similar to (ACF) procedure t. mechanism Two a floating potential replacemen years of good that sacrum fused. that a mechanism disease n of sacroiliacand for total disc a had their segment were fused the presentatio lumbar surgery he contended of adjacent The case involved following (±1.4) segments average. After lumbar fusion joint pain. male patient joint pain surgery. on it offers predictable following 30-year-old al fusion who sacroiliac fusion each patient herniated lumbosacr nt difference g 66 patients pain results. This could explain has has reported with a two-level C5–6, insignifica determinin however, literature and Given the of this low back lower procedure, A body of presence disc at C4–5 with of loads to d had developed through the between the ively been associated on the transfer straightening who had experience pain incidence postoperat of medical records, the including on a significant levels from in adjacent symptoms investigati segment the neck segments and physical, of adjacent arms fused used of of in both In the case the authors and imaging results he admits. years. The al pathology, segment disease.pain, loads might for over five neurologic radicudebate, joint which patients To win the sacroiliac from fused patient displayed failed to identify total disc had joint. this as a result he argues, also be transferred lopathy, and treatment.

The had developed t would onto the sacroiliac ive joint pain. the study replacemen segments non-operat note that something of sacroiliac sacroiliac block no The authors retrospective ard have to offer Imaging revealed on page 2 gold-stand by its Continued deformity. ed in patients is limited y with significant was administer sacroiliac joint particularl first, Abitbol ion design, Speaking with suspected was made in the identificat regards to pain. Diagnosis to the who had latent on page 2 according of patients ded Continued 28 patients criteria recommen diagnostic et al (J Orthop

by Murakami 74–80).

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