Spinal News International Issue 50 – March 2019

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Single-level anterior cervical discectomy provides “solid alternative” to fusion or arthroplasty Results of a double-blinded randomised controlled trial indicate that anterior cervical disc arthroplasty (ACDA) does not lead to a superior outcome in comparison to anterior cervical discectomy with fusion (ACDF) or anterior cervical discectomy (ACD) alone. Subsequent investigation involving a larger patient cohort supports the “remarkable” nature of the similarity between outcomes of the three treatments, and even subgroup analysis “does not indicate that a certain type of patient would benefit more from one particular treatment strategy.”

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n contrast to what is generally believed,” the investigators comment, the Netherlands Cervical Kinematics, or NECK, trial demonstrates “no significant differences” in clinical or radiological outcomes along single level ACDA, ACDF, and ACD. They conclude that all three options are “acceptable” forms of treatment and suggest that ACD without implanting an intervertebral device “may be a reasonable alternative” to ACDF or ACDA. Writing in The Spine Journal, Carmen LA VleggeertLankamp of Leiden-the Hague Spine Center (LUMCHMC; Leiden/The Hague, The Netherlands) and colleagues found “no strong evidence” in favour of one of the three treatment strategies based on a two-year evaluation. Co-author Caroline MW Goedmakers (LUMC-HMC) presented a subgroup analysis based on the NECK trial and the Procon trial (conducted by Ronald Bartels and Roland Donk in Nijmegen, The Netherlands) combined, which found only “small differences” in treatment effect. These subsequent results were presented at the 46th annual meeting of the Cervical Spine Research Society in Scottsdale, USA (CSRS; 6–8 December, 2018).

Based on the available literature, Vleggeert-Lankamp and colleagues hypothesised that ACDA would lead to a “superior clinical outcome” in comparison to ACDF or ACD. In order to investigate this, 109 patients were randomised into one of three treatment groups: ACDA, ACDF with an intervertebral cage, and ACD without fusion. The authors measured clinical and radiological outcome by neck disability index (NDI), Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF36, EQ-5D, patients’ selfreported perceived recovery, radiographic Carmen LA Vleggeert-Lankamp cervical curvature, and adjacent segment degeneration parameters at baseline until two years after surgery. BBraun Medical paid €298.84 to cover the costs for research nurses.

The authors conclude that “no statistical differences were demonstrated between the treatment groups.”

Specifically, the NDI declined from 41 to 47 points at baseline to 19±15 in the ACD group, 19±18 in the ACDF group, and 20±22 in the ACDA group after

surgery. VAS arm and neck pain declined to half its baseline value and decreased below the critical value of 40mm. Quality of life, measured by the EQ-5D, increased in all three groups. Adjacent segment degeneration parameters were comparable in all three groups as well.

Vleggeert-Lankamp and colleagues comment on the potentially positive financial consequences of the study findings. Given that surgery with a prosthesis is “more expensive than tested alternatives,” the results that ACD is just as effective as both ACDA and ACDF may allow for savings to be made. They also mention a probable time saving element, as surgery to introduce a prosthesis is “longer and more challenging.” It has been demonstrated that this does not lead to more complications during or after surgery, however.

Since first described by Smith, Robinson, Cloward, Dereymaeker and Mulier in the 1950s, ACDF has been the “standard surgical treatment” for patients suffering from radiculopathy due to a herniated disc, Goedmakers comments. However, it is hypothesised that fusing the segments may increase the incidence of adjacent segment disease. In order to simulate the mobile characteristics of a cervical disc, the cervical intervertebral disc prosthesis was introduced.

Following the introduction of the prosthesis, the device has been the subject of several clinical and biomechanical studies. Trials comparing ACDF

The hypothesis that arthroplasty would lead to superior clinical outcome in comparison to fusion or discectomy alone could not be confirmed at two years.” and prosthesis (ACDA) were widely performed but focused mainly on safety rather than superiority of the prosthesis.

Some years after the description of ACDF, anterior cervical discectomy without fusion (ACD) was reported. Although “very promising,” according to Goedmakers, it received less attention. The major Continued on page 2

Tim Germon: Low back pain

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Matthew Scott-Young:

Profile

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Banned in the USA: Petition calls for FDA to prohibit reprocessed pedicle screws

Aakash Agarwal (Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence, University of Toledo, Toledo, USA) has filed an official citizen petition to the US Food and Drug Administration (FDA) calling for a ban on the reprocessing of pedicle screws in the USA. The letter and the accompanied evidence have now been formally accepted by the FDA for review, though an FDA spokesperson said that the process could take over a year, depending on how the agency assess the urgency of the petition.

AGARWAL REQUESTS “THE Commissioner of Food and Drugs to cease clearing 510(k)s and approving PMAs [pre-market approvals] for reprocessing of pedicle screws and other implantable orthopaedic devices and cease clearing 510(k)s for re-usable implantable orthopaedic device[s].”

In addition to asking for the cessation of approvals for reprocessed pedicle screws and interbody cages, the petition requests that every implantable orthopaedic device should be provided “such that it is not touched or exposed before implantation, by the operating room staff, in the sterile field.”

Summarising his reasons for filing this citizen petition, Agarwal enthuses: “Practicing and improving asepsis is at the core of surgical philosophy!”

This petition follows the news that implants are getting contaminated in two separate steps, as reported in the September 2018 cover story of Spinal News International. Contamination occurs outside the operating room, due to the reprocessing of pedicle screws, and also inside the operating room, when the devices left exposed within the “sterile field” are infected with several common bacterial strains.

Speaking to Spinal News International, Agarwal explains how evidence from the literature underpins his rationale for worrying about reprocessed pedicle Continued on page 4

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Single-level anterior cervical discectomy provides “solid alternative” to fusion or arthroplasty Continued from page 1

comment was local kyphosis and thus ACDF became the “golden standard,” Goedmakers comments. “We assume that this is the reason that all recent comparative studies focused on arthroplasty and ACDF, while ACD has not been given proper attention.” In the present study, however, the authors note that only two patients developed kyphosis.

In order to substantiate their results, the authors note that “larger studies with subgroup analyses are needed.”

They also comment that the follow-up period of two years is a limitation of the present study. It is possible that adjacent level disease will occur after this period and that is has subsequent clinical effects. “We do, however, consider a follow-up period of two years an appropriate length of time to compare the initial clinical outcome of the three surgical methods.”

Individual level I studies find fewer reoperations with arthorplasty

Talking to Spinal News International, Jack Zigler comments that: “While it is true that clinical outcomes are not significantly different between arthroplasty and ACDF or ACD [at least in the short term], reoperation rates in every one of the US Investigational Device Exemption (IDE) trials of cervical artificial disc replacement (ADR) versus fusion showed significantly fewer reoperations in the arthroplasty group, at every temporal data point.” He explains how “these were all individual Level I studies with prospective randomisation and high percentage multi-year follow-

up. Several meta-analyses demonstrated this differential favouring ADR. IDE follow-up data was published for most implants at seven years.”

Despite the “excellent methodology” of the NECK trial, he adds, “this level of evidence [in the Level I studies mentioned above], generalised by thousands of geographically separated patients, hundreds of surgeons and site, with FDA oversight of methods and analysis, should be given stronger consideration than the 109 patients followed for only two years in the NECK trial.” He mentions that discectomy without fusion, for example, “may have equivalent two year outcomes to other reconstructive techniques, but is acknowledged to frequently result in later disc space collapse with recurrent foramenal narrowing and malalignment.”

No significant difference between procedures in larger cohort

Addressing the issue of cohort size at the CSRS annual meeting at the end of last year, co-author Goedmakers described a follow-up study in which data were collected from the 109 patients included in the NECK trial and 142 patients from the Procon trial and combined, creating a total study population of 251 patients. The cohort was then divided into three treatment groups— ACD (83 patients); ACDF (83) and ACDA (85)—and was deemed large enough to allow for subgroup analysis.

In this larger patient cohort, the authors describe how the NDI decreased “comparably” in all treatment

As a result of the larger sample size in the combined dataset of two randomised controlled trials, subgroup analyses for body mass index, age, gender and smoking could be performed.”

Caroline MW Goedmakers

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arms from 39.58–41.85 preoperatively to 14.62±3.1 (ACD), 22.5±3.6 (ACDF) and 22.7±4.3, (ACDA) after two years. Treatment effect differences were 0.688 (CI -4.62 to 5.99; ACDF vs. ACD), 1.113 (CI -4.77 to 6.99; ACDA vs. ACD) and 0.424 (CI -5.79 to 6.64 ACDA vs.

ACDF) on a 100-point scale. In all three comparisons the treatment effect never exceeded the Minimal Clinical Important Difference (MCID) of 20 points. They found that results for the secondary outcome scales were also comparable. Subgroup analyses for gender, age, BMI, smoking and disc height at baseline demonstrate small differences in treatment effect without exceeding 20-point MCID borders, the investigators remark.

Goedmakers and colleagues describe how variables were analysed at baseline and at two years postoperatively. Subgroup analysis was performed for gender, age ≤40 and >40, BMI ≤30 and >30, smoking/ non-smoking and disc height at baseline. To account for the correlation between repeated measurements Generalised Estimating Equations (GEE) were used.

Study type was added as a fixed effect to correct for differences between the two studies.

Both the NECK trial and the Procon trial included patients with radicular signs and symptoms in one or both arms due to a single level cervical intervertebral disc herniation and/or an osteophyte in accordance with MRI findings. Both studies chose Neck Disability Index as the primary outcome variable, and subscales of the SF36 and McGill pain score as secondary outcome parameters.

The numbers of patients in randomised controlled trials (RCTs) are generally small, the investigators note, and therefore the results of two RCTs with comparable set up were combined. Both RCTs also included a group of patients in which no intervertebral device was implanted. As a result of the larger sample size in the combined dataset, the authors remark, subgroup analysis for BMI, age, gender and smoking could be performed.

Goedmakers comments: “It is possible that adjacent level disease will occur after the period of two years and that this would have subsequent clinical outcome effects.

However, the Procon eight-year follow-up results do not demonstrate this tendency.”

She adds that another limitation of the study is the compliance, which she mentions “decreases rapidly over the years.” However, “with 159 patients having a complete follow-up record at 104 weeks postoperatively, she remarks, “we can still draw conclusions with sufficient power.”

Goedmakers concludes that further to the CSRS presentation, data of longer follow-up periods will have to be collected and “critically evaluated” in order to verify if the conclusions of the NECK trial remain unchanged in the long term.

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Banned in the USA: Petition calls for FDA to prohibit reprocessed pedicle screws Continued from page 1

screws: “Research has identified that orthopaedic implants undergo repeated bulk-cleaning with dirty instruments from the operating room, leading to microbial and non-microbial residue build up at the small interfaces and possibly on the surfaces.

This remains unnoticed by the Sterile Processing Department or other hospital staff, as there is no way to inspect each of the hundreds of implants at microscopic levels individually, and at interfaces not directly visible.

“Furthermore, the implants are also being contaminated intraoperatively. Sterile implants are directly touched by the scrub technician with soiled gloves for loading onto an insertion device.

They are then kept exposed on the working table.

A multicentre trial has shown that by the time it is implanted in the patient, it can harbour up to 10e7 bacterial colony forming units. Additionally, one study group used a functional, impermeable sterile guard around the implant to intraoperatively shield the device until insertion into the patient; they reported zero contamination. Thus, [the use of a sterile guard represents] an effective precautionary measure against possible surgical site infection (SSI), or subclinical and chronic sepsis leading to screw loosening and pain.”

The likelihood of post-operative infection depends on three factors: (i) the bacterial concentration left from surgery; (ii) the virulence of said bacteria; and (iii) the patient’s immune (natural or boosted by antibiotics) response at the surgical site. Not all patients will have infections, but some will. Agarwal points to a recent randomised trial from Mount Sinai Beth Israel hospital in New York, USA, that found a 12.7% infection rate. He explains: “It is in the patient’s best interest to be exposed to the lowest bacterial dose during surgery; many of these patients are also immunocompromised and have at least one associated high-risk factor that predisposes them to infection, such as old age, obesity, smoking, diabetes mellitus, ischemia secondary to vascular disease, or irradiation.”

complications (such as infection or hardware loosening).

Now, as it is an official investigation, the particular department of our government is also liable for public safety from the contaminated implants—as this has been brought to their attention.”

He continues: “I think it [the high post-operative infection rate caused at least in part by reprocessing pedicle screws] simply slipped through the cracks in the US system. The system is very disjointed, and one half does not know what the other half is doing.

Surgeons themselves do not clean the implants, and the decontamination and cleaning departments have no say on how the industry works; it is their job to clean it as per the standard operating procedure of the hospital. For industry, large companies are risk averse, and whoever makes this decision will be held responsible. So, for them sometimes it is safer to not make a decision. At other times, they cannot foresee the value [of taking a certain action, such as banning reprocessing orthopaedic implants].

“However, industry is now realising that this major upgrade would avoid risky and uncertain repeated reprocessing, the need for backup inventory, and logistical challenges such as storage and identification.

Way more than six billion pedicle screws (imagine the number if we also account for all other orthopedic devices) are stored in US hospitals. Half of the stored inventory capital from that could be freed up by packaging them in individual sterile tubes (because it is always surgery ready: lean system flow), and that monetary resource can be used for other developmental work and/or growth.”

Furthermore, Agarwal states in the petition that there is no negative environmental impact of the banning of reprocessed pedicle screws, but notes that there would be some environmental advantages, specifically in the reduction of water and electricity use that would arise from no longer repeatedly cleaning or sterilising the devices at the hospital or in other facilities.

Agarwal is director of Research and Development for Spinal Balance, a company providing sterile and proprietary no touch orthopaedic implants. He is also an editorial board member for Clinical Spine Surgery & Spine, as well as an advisory board member for the Center for Musculoskeletal Disruption and Innovation as part of National Science Foundation. He claims royalties from Joimax and Paradigm Spine.

The petition requests that every implantable orthopaedic device should be provided such that it is not touched or exposed before implantation in the sterile field.”

Citing the 12.7% infection rate, Agarwal postulates: “That could represent up to 100,000 patients suffering from surgical site infection in the USA alone. Now multiply that over the entire globe—isn’t this is a serious cause for concern?”

There is a precedent for this action, as the Scottish government has already banned the reprocessing of spinal implants used in surgery. The Scottish Health Department said in a statement that repeatedly reprocessing implants in the hospital “is a suboptimal procedure”, following a letter in 2006 from the then chief medical officer for Scotland, Harry Burns.

Asked if he thinks the FDA would approve this petition, Agarwal comments, “I hope so. Previously, only industrial and clinical teams were liable for surgical

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Reprocessed pedicle screws

According to a study reported in Spinal News last September, streaking revealed more bacterial contamination on presterilised, prepackaged pedicle screws without a guard than on presterilised, prepackaged pedicle screws with a guard

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N20: Spine in the spotlight at global meeting The Society for Brain Mapping and Therapeutics (SBMT) and the Brain Mapping Foundation (BMF) recently hosted their 5th Annual Neuroscience-20 event in Buenos Aires, Argentina (N20; 26–27 November). For the past five years the goal has been to get neuroscience treatments and innovation on the radar for the G20 meeting, the main international forum for economic, financial and political cooperation.

PRESENTLY, THE GLOBAL economic burden of brain, spine, and other nervous system disorders amounts to over US$13 trillion annually.

Organisers of the N20 believe that if G20 nations understand the immense scope of neuroscience-related disability issues facing the globe, they can work together to find treatments and fund innovative research, including spine research. In 2014, the first N20 meeting was held in Australia and over the last five years the group’s aims have been clarified.

This year, the North American Spine Society was involved for the first time, bringing spinal issues into focus. Key talks covered numerous topics, ranging from spinal care in a global context and its associated costs, to technological advances, such as navigation, robotics, and 3D virtual planning.

The programme this year also featured thought leaders in neuroscience from the EU, USA, Argentina, Chile, Brazil, and Turkey. At the end of the twoday meeting, Babak Kateb, founding chairman of the board and CEO of SMBT, and Alejandro Mercado, president of N20-Argentina, presented the group’s neuroscience recommendations to ministers, ambassadors and VIPs of the G20 nations.

Jeffrey Wang, NASS president and president of SMBT, is committed to a global approach to spine care. “It is important to be organised on an international level,” he told Spinal News International. “The incidence of spine disability is increasing and to address this, we need to raise awareness and pool resources,” he continued.

He noted the importance of getting

Global spine “everyone at the table” and ensuring there was a focus on preventive, non-operative measures as well as developments in spinal surgery. He stressed that “tangible projects” will be the way to achieve the ambitious yet necessary goals of the N20.

Kateb has been heavily involved in global neuroscience legislation and policy for several years. He has chaired seven Brain Mapping Day briefings on the latest innovation in brain and spine diagnostics, therapeutics and policy as well as topics related to the wounded soldiers and veterans with neurological disorders at the US Congress and organised several brain mapping days at the Canadian and Australian Parliaments in 2012 and 2016, respectively. He was also one of the key players in President Obama’s BRAIN initiative.

We need to be organised on an international level. The incidence of spine disability is increasing and, to address this, we need to raise awareness and pool resources.”

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Speaking exclusively to Spinal News International, Kateb says we need “robust global partnerships” in order to “push innovation and reduce the costs of healthcare”. He believes progress is being made, however gradually, and that an increased emphasis on spinal care is a positive step forward.

The N20 group plan to publish the recommendations it made at this year’s summit in high impact scientific journals, publicising findings and recommendations through a series of press releases. Some of their specific aims for this year were to account for the global economic burden of diseases and injuries of the brain, spine, retina, and peripheral nervous system, promote a whole-of-government approach to address brain and spine disease and injury (BSDI), and to fund the responsible application of technologies associated with the digital transformation for brain and spine research and clinical treatment.

Their recommendations included encouraging the funding of studies analysing the economic burden of neurological, psychiatric and spinal disorders, and more importantly, the establishment of an international data repository, encouraging investment and global networking, initiating preventive programmes, improving technologies and creating global regulations and guidelines.

The next N20 meeting is set to take place 27–28 June 2019 in Osaka, Japan.

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Expanding access to surgery on a global scale Universal health is a top priority at the Weill Cornell Brain and Spine Centre in New York, USA. Their global neurosurgery programme, a collaborative project designed to improve access to surgery and surgical care across the world, has been running for the past 10 years.

Spinal News International reached out to Roger Härtl and Babacar Cisse, both instrumental in the programme’s delivery, who here discuss the importance, achievements and future of this project.

Roger Härtl performs surgery in Tanzania (courtesy Weill Cornell Medicine Neurosurgery)

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recent study in The Lancet showed that five billion people do not have access to emergency or essential surgical care. According to Härtl, there is a worldwide shortfall of 23 million neurosurgeons and 14 million neurosurgical procedures. This problem is especially apparent in a country such as Tanzania which, in 2008, had just nine neurosurgeons for a population of 50 million. Ten years on, there are now 12 neurosurgeons in the country, though all save one are clustered in Dar es Salaam, and the growing population is burdening the healthcare service.

2008: Tanzania

In 2008, Roger Härtl and a small team from Weill Cornell set out to Tanzania. This inaugural trip marked the beginning of a global health project that a decade on has changed and expanded from an annual trip to include daily communication, a “self-sustaining” model that represents far more than the sum of its parts, as Härtl describes it to Spinal News International.

Tanzania was a natural starting point for Härtl, who had spent time there as a medical student and was eager to return once fully qualified. Coincidentally, he treated the President of Tanzania at the time, Jakaya Kikwete, during his residency. The following year, the president invited Härtl to Dar es Salaam. While there he visited MOI, the largest hospital in Dar es Salaam, and where the need for a neurosurgeon was “very clear”.

Härtl and his team recognised two main problems: there was a lack of infrastructure to be able to carry out the volume of surgery needed, and where surgical care was available, it was very difficult to access. Equipment

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Global spine

was not maintained and the lack of an insurance system meant patients generally had to pay for surgery upfront.

Over the past 10 years, Härtl has been travelling back and forth to Tanzania. “Through trial and error,” he and his team are working towards building a sustainable programme between their facilities in New York and those in Tanzania.

In terms of funding, there has been an “overwhelming” response from patients and companies, some donating tens of thousands of dollars to the global health programme. It was recognised that a week-long annual visit was not the best way to reach the project’s potential, but the question remained—what was the best way to put a large amount of funding to use in a way that would maximise their impact? The solution, they realised, would revolve around education and training.

Härtl describes the project now as “self-sustaining”.

The Tanzanian doctors he has trained are now organising an international meeting every year. The volume of spine cases has significantly increased over the years, but Härtl makes it clear that the number of surgeries per se is not necessarily an indicator of success. Who to operate on and what surgery to do is far more important.

2018: Senegal

In September 2018, Babacar Cisse took the programme to his native Senegal, representing the most recent addition to a project that aims to improve surgical care on a global scale.

Cisse told Spinal News International how the recent trip he made to Senegal centred around finding out what the surgical reality is there, what is lacking, and what

can be done to help. He mentions how he encountered a number of “pleasant and unpleasant surprises”.

Specifically, he found that “the neurosurgery programme was very well structured, the hospital he visited had a specific clinic dedicated to neurosurgery, and the surgeons were incredibly talented.” He adds that the surgeons he worked with in Senegal “taught the Cornell team what you can do with limited resources.” On the other hand, he notes how there was only a six-bed Intensive Care Unit and that the equipment and supplies available were old. “We take a lot for granted here in the USA,” he says.

On the differences between surgery in New York and Senegal’s capital, Dakar, Cisse comments that when you have limited resources “you become a different surgeon.

There are things that you can do as a surgeon in New York that you cannot do in Dakar and you would end up harming a patient if you tried.”

Cisse notes how the new Senegal mission will commence on a yearly basis. As his family lives in Senegal, however, he will also perform surgery whenever he goes back to visit. He wants young neurosurgeons from Senegal to come to New York to do some training and also intends to conduct weekly meetings over Skype, both elements which have been so successful in Tanzania.

Building on the Tanzania model and an assessment of access to surgery in Senegal, Cisse aims to make Dakar a “centre of excellence.” He makes it clear, however, that this project is about far more than individual projects in Tanzania and Senegal. “This is about training the next generation of neurosurgeons,” he says. What they aim to do beyond teaching neurosurgical skills is to teach how to run a functional neurosurgical programme and how to run a neurosurgical hospital. This will take time. “Rome was not built overnight,” Cisse quotes.

Cisse emphasises that for him the project represents a two-way exchange of ideas. It was not his intention to go to Dakar and say “this is the American way” or “this is the Cornell way”. He suggests that the best way to make changes is to recognise and combine the best of the knowledge and resources both countries can offer in order to make the most meaningful impact. What matters most to him is not what either party wants to do, but what is best for the patient.

Collaboration and communication

Central to the whole project is a two-way collaboration between the surgeons at Cornell and those in the counties they visit, a partnership which Härtl believes must be based above all else on understanding. “You cannot transfer expectations and backgrounds to a system that is completely different to the one that you are used to,” he says. The doctors in Tanzania “work in a totally different system and have completely different priorities. They are underpaid and overworked.”

Härtl told Spinal News International how some of his colleagues from New York would get quite frustrated at the lack of organisation, but for the most part any problems arose from a lack of communication. “That is the most important thing I learnt,” he says. “Rather than judging, let us find out what is going on.”

Both Härtl and Cisse stress the central role of communication going forward. Once a week Härtl has a 6am Skype call with his colleagues in Tanzania.

Instead of going over once a year and taking with them a lot of equipment they now have a “more meaningful interaction.” This weekly call, along with multiple texts and Whatsapp messages with attendees, means they work together on a nearly daily basis now.

On a personal level, Härtl mentions the good relationships he has with surgeons in Tanzania as the most rewarding aspect of the initiative so far. He stresses the importance of trust and how valuable these relationships can be in effecting change. “It is difficult to understand the reasons behind hesitancy to adopt new methods and this process of building trust and creating partnerships is not easy,” he remarks, “but certainly worthwhile.”

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You cannot transfer We have a duty to expectations to a make things better system that is completely for future generations. different from one that you After all, a legacy is a are used to.” second life.”

Roger Härtl

Babacar Cisse

Härtl tells the paper about two surgeons who have made the time he has spent in Tanzania particularly memorable. One, Isidor Ngayomela, works in Bugando hospital and the second, Nicephorus Rutabasibwa, is a spine surgeon at MOI. Härtl describes him as a “talented spine surgeon” interested in minimally invasive spine surgery—Härtl’s specialism in New York. “He picks up techniques quickly and is able to translate those into action in the limited resource setting in which he works,” Härtl praises.

present no protocols in place, and he mentions how the limited resources available “are not always being used on patients who could really benefit”. Härtl and his team would like information like this to be documented, leading to evidence-based protocols to try to influence the decision-making process.

In addition, Härtl would like to accurately document severe traumatic brain injury, for which the current mortality rate is around 60%. He aims to implement protocols and train people to improve that figure. This will take time but they are making progress, including publishing papers and involving politicians and decision-makers in healthcare. Back in October 2018, Härtl had a “very promising” meeting with the new president of Tanzania, John Magufuli. Whether or not this connection will make a difference though, Härtl is

Looking to the future

Härtl and his team have clear goals for the future of the project in Tanzania. Going forward they aim to help doctors they have met to train people locally and to document the current status of care. There are at

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uncertain. He believes that training and teaching at the local levels and publishing data to show the reality of the situation will be the way to make changes.

Going forward, Härtl describes tangible collaboration as the “core component” of the project. Six years ago, there was a neurotrauma meeting in Dar es Salaam involving participants across all of East Africa. The event involved two days of lectures and practical courses, followed by three days of operating together.

In January 2019, Weill Cornell organised a global neurosurgery course in New York.

Another important component will be continuing to fund one trained neurosurgeon from North America or Europe to spend a year in Tanzania teaching and training. To date, two neurosurgeons, Maria Santos from Portugal and Andreas Leidinger from Spain, have each spent a year in Tanzania. Some of the donations also go towards funding surgeons and nurses from Tanzania to spend three months at a time in New York. They form an important bridge between the two facilities and act as “ambassadors and champion surgeons” of the initiative.

Talking finally about the wider significance of the project, Cisse remarks that “as a society, we have to think about what we are doing and not wait until the problem is acute and, for this to happen, priorities need to be shifted”. In his opinion, a public health campaign is important, and this has to start now at the level of the medical school.

He finds it “heart-breaking” that while we are talking about the same human beings, the only difference is on which side of the Atlantic you happen to be. “Health problems are not a reality until they hit you or a close family member,” he remarks, and “only then do you realise what the hospital does and does not have, and also how the system works.”

Cisse strongly believes that “we have a duty to make things better for future generations”. That will be the legacy that we will leave behind, he says, “and after all, a legacy is a second life”.

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“The best of all worlds”: A surgeon’s clinical experience with the Lucent® XP Expandable Interbody device Hyun W Bae, MD, is a medical director at The Spine Institute (Saint John’s Health Center, Santa Monica, USA) and professor of Surgery at Cedars-Sinai Medical Center (Los Angeles, USA). An orthopaedic spine specialist, Dr Bae is a leader in minimally invasive surgery, motion preservation technology, artificial disc replacement, and non-fusion technologies.

Alongside his clinical practice, Dr Bae is a prominent researcher and has been published extensively in top journals and presented at many national and international meetings. Here, using examples from his clinical practice, he discusses the benefits of using the Lucent XP Expandable Interbody device (Spinal Elements) made from PEEK-OPTIMA™ Natural polymer (Invibio Biomaterial Solutions™) and titanium during spine surgery.

Key features of the Lucent XP Expandable Interbody fusion device

The Lucent XP Expandable Interbody device is a unique addition to the spinal fusion market. The main features of the device are its ability to expand in height and increase in lordotic angle after it has been surgically implanted. It can expand up to 3mm, which helps restore the height of the spinal disc space and the lordotic angling helps correct the curvature of the spine. Surgeons are able to achieve up to 15 degrees of lordotic angle with the Lucent XP Interbody device, helping restore sagittal balance for the patient.

Another key features of the expandable device relates to its multifunctional surface material. A titanium-coated PEEK device, the radiolucent properties of the PEEK material allow for superior imaging quality compared to other materials on the market. This enhances crucial post-operative evaluation of the fusion progression. It also has a lower modulus of elasticity than titanium. In addition, the mechanical properties of PEEK along with the design of the device allow for a more load-sharing construct.

Given these benefits, it is not surprising that Dr Bae has chosen to use the Lucent XP Expandable Interbody device in his clinical practice. Talking to Spinal News International, he explains how it has become an integral part of his practice and expresses his high level of satisfaction with regard to imaging, fusion assessment and overall clinical outcome.

He focuses in particular on the qualities of the titanium-coated PEEK surface. He mentions that “the roughened surface of titanium-coated PEEK is more biologically and bone friendly. It is able to interact with the bone far better than smooth PEEK,” allowing for a more positive outcome for his patients.

The radiolucency of the PEEK material has also contributed to his positive experience with the device. The improved imaging quality has made his post-operative assessments far more useful for both patient and practitioner. “The imaging qualities of PEEK are far superior to its competitors,” he says.

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Advertorial

A better device for patient and practitioner

Dr Bae mentions specifically how easy the Lucent XP Expandable Interbody device is to use. It gives “great feedback”, with the torque limiter being an “excellent addition” to the cage. He also comments on how the device compares favourably to 3D printed titanium cages, noting in particular that the unique Ti-Bond coating offers the best features of both titanium as well as PEEK. “The device has the strength of PEEK with the benefits of microtextured titanium,” he remarks.

Ultimately, Dr Bae says that he chose to adopt the Lucent XP device over other available expandable cages because it “provides the best of all worlds”. He reiterates the superior surface grip and friction that are essential to a successful procedure. This, in tandem with the best qualities of PEEK and titanium, makes for a high-quality device with noticeable advantages over other devices.

Addressing the concerns of surgeons who might consider PEEK an inappropriate material for an expandable cage, Dr Bae stresses the reliability of the material. “I have never seen a PEEK cage collapse on itself,” he tells Spinal News International.

The Lucent XP Expandable Interbody device has had a noticeable and positive impact on Dr Bae’s clinical practice, allowing for a smooth surgical procedure for both his patients and himself. Another key benefit for the patient is that recovery time is rapid. Dr Bae describes two specific cases during which he had used the Lucent XP device. One of these cases relates to a patient who is an avid cyclist, but had been experiencing severe back pain for 10 years. After undergoing a bilateral transforaminal lumbar interbody fusion using the Lucent XP Expandable Interbody device, she was in the hospital for just one night post-operatively. Now, one year later, she is not only actively working but is also back into cycling.

In essence, the Lucent XP Expandable Interbody device offers a simple solution to the many complexities of spinal surgery. “The device is easy to use,” Dr Bae concludes. “Its ability to expand in height and restore lordotic angle are exactly what I need to address the challenges of spinal fusion.”

Transforaminal Lumbar Interbody fusion in a middleaged female using the Lucent XP Expandable Interbody cage Case description A 55-year-old female patient presented with severe low back pain and bilateral lower extremity pain with standing and walking. She has had lower back pain for approximately 10 years, however this was exacerbated after a car accident and can now stand for only five minutes without pain. She has had multiple injections to include epidurals and facet rhizotomies. She has had physical therapy over the past year and has presented with bilateral extensor hallicus longus weakness 4+/5.

This individual had a decreased sensation to light touch and pinprick within an L5 and S1 distribution.

Surgical intervention We performed a bilateral transforaminal lumbar interbody fusion at L5–S1 with cortical screws and a Lucent XP Expandable Interbody cage from Spinal Elements.

Outcome The patient was discharged from hospital the day after surgery. At one year, she is experiencing no back or leg pain and is actively working. The patient is a cyclist and she is also back to cycling.

Transforaminal Lumbar Interbody fusion in a middleaged male using the Lucent XP Expandable Interbody cage Case description A 60-year-old male, who denies injury or trauma, presented with severe left lower extremity pain for one month. He had increased pain with standing for longer than 10 minutes. He walked with a limp because of pain and numbness, and could not walk more than a block without needing to stop. He has had one caudal epidural and one selective nerve block with no relief of symptoms.

This patient has also tried physical therapy, which resulted in increased pain. On examination he has weakness in the left foot with 4+/5 anterior tibialis and 4/5 extensor hallicus longus. He had decreased sensation to light touch and pinprick in a left L5 distribution. Ankle jerk was absent on the left and an MRI of the lumbar spine revealed an extraforaminal disc herniation at L4–L5.

Surgical intervention We performed a left-sided transforaminal lumbar interbody fusion at L4–5 with cortical screws and the Lucent XP Expandable Interbody cage from Spinal Elements.

Outcome The patient was discharged from hospital after a two-night stay and is now at one and a half years’ post-surgery. A retired police officer, he is now back to work as a security guard and plays golf regularly. He has minimal pain and only occasionally takes Advil.

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Advertorial

Pre-op sagittal MRI

Pre-operative sagittal MRI

12-month post-operative sagittal X-ray

12-month post-operative sagittal CT scan

Pre-operative axial MRI

12 month post-operative coronal X-ray

12-month post-operative coronal CT scan

Pre-operative sagittal MRI

12-month post-operative sagittal X-ray

12-month post-operative sagittal CT scan

Pre-operative axial MRI

12-month post-operative coronal X-ray

12-month post-operative coronal CT scan

Pre-op axial MRI

INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. Lucent® is a registered trademark of Spinal Elements.

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Low back pain

Non-specific low back pain: Returning to the Dark Ages While non-specific low back pain (NSLBP) is a common diagnosis, Tim Germon (Derriford Hospital, Plymouth, UK) argues that most low back pain is in fact specific. He speaks about the importance of reaching a diagnosis in order to drive effective treatment, focusing in particular on the often underdiagnosed structural causes of pain, and pain as a manifestation of psychological distress, which, in his opinion, must be treated as a specific diagnosis.

Tim Germon Comment & Analysis

I

n the sixth century BC Pythagoras had mathematical proof that the sun was at the centre of the solar system and that the earth was in orbit around it. However, around the beginning of the Common Era, the scientific advancements made by the Greeks were displaced by religious dogma. For 2,000 years, people attempted to explain the observed motion of the planets in geocetric terms. This was doomed to fail. It is impossible to explain the observations of the planets by using a model that is fundamentally incorrect. In the 16th century, Copernicus rediscovered what the Greeks had known 2,000 years previously.1 It was the dawn of the “Age of Reason” or “Enlightenment”, when people sought rational explanations for the world around us. Huge advances were made

there is little rationale for intervention.

Only with a meaningful diagnosis can there be discussion of the risks and benefits of potential interventions.

Interventions not based on diagnosis risk being dishonest.2 Inadequate attempts at making a diagnosis will mean people for whom effective treatment may be available may not be identified.

NSLBP is a label, it is not a diagnosis.

Therefore, the rationale for treatment will be questionable and it is likely to be ineffective. This is confirmed by the literature. A meta-analysis of effect sizes for non-surgical treatment of NSLBP confirms effect sizes are what we might expect from a placebo.3 The largest effect size identified in this paper is 0.6 for acupuncture. This compares extremely poorly with total hip replacement,

of surgical intervention. Surgery, for example to treat nerve root compression, can be extremely effective in treating pain. We have measured the change in pain score following surgery for nerve root compression in 867 unselected consecutive patients. The effect size for treating pain was 2.5, the same as total hip replacement and off the scale compared to conservative treatment.7 But what if there is no apparent diagnosis? What are the possibilities?

There are four: (i) The diagnosis has been missed; (ii) the person has a condition as yet unrecognised; (iii) The person has a central sensitisation syndrome; or (iv) the person has psychological distress manifesting as pain. The third and fourth possibilities may be different perspectives of the same thing.

As physicians we have to be sure that a structural diagnosis has not been missed. It is my observation that dural compression syndromes, for which extremely effective surgery is available, are commonly underdiagnosed. There are three reasons for this. Firstly, whilst we generally agree that nerve root decompression provides good relief of pain, we cannot agree on the distribution of pain which is a potential manifestation of nerve root compression. We have

Inadequate attempts at making a diagnosis will mean people for whom effective treatment may be available may not be identified. ” in all aspects of science and technology, including medicine. The Hippocratic principle of making a diagnosis on which rational treatment could be based was recognised.

Very few, if any, people disagree that the Hippocratic principle of making a diagnosis should form the foundation of medical practice. This is the fundamental skill of a Doctor of Medicine. Yet, 400 years after the beginning of the Enlightenment, it is permissible, even encouraged, for physicians to use the phrase “non-specific low back pain” (NSLBP) as a diagnosis. No criteria, other than that there is no explanation for the person’s pain, is required. There is no minimum requirement in terms of the expertise of the person making the assessment or of investigations required.

It is like returning to the Dark Ages.

Not everyone with low back pain requires a diagnosis. Most pain resolves without intervention. However, if treatment is to be prescribed, then a diagnosis is required. Without a diagnosis

which is one of the most effective pain treatments we have with an effect size of 2.5.4 The same is true of spine surgery.

A paper from 2005 concluded that spinal fusion was no more beneficial than intensive rehabilitation.5 It seems bizarre that it was acceptable to operate on people when there was no clear diagnosis. Perhaps this paper was of its time. However, it remains permissible to perform fusions on people with the label NSLBP as part of a trial according to current UK guidelines.6 Hippocrates would weep.

If we apply basic Hippocratic principles, a person presenting with persistent disabling back pain should see a person trained in making a diagnosis—a doctor. The doctor takes a history, performs an examination and arrives at a differential diagnosis. An MRI scan is overwhelmingly the best test to confirm whether this is the case or not. If a structural cause for pain is confirmed then it is appropriate to discuss the potential risks and benefits

found that, of 123 sequential people undergoing very successful surgery for lumbar nerve root compression, only one fulfilled the diagnostic criteria required

by UK national guidelines to diagnose sciatica. The rest would not have been imaged or seen a spine surgeon if these guidelines had been adhered to.8 Secondly, people do not believe that dural compression causes back pain, despite overwhelming evidence to the contrary, with Owens et al contributing the most recent paper to add to the body of evidence.9 Thirdly, nerve root compression is unreliably recognised by radiologists.10 What about the rest? There is little we can do when we really do not know the cause of a person’s pain. But if the patient is suffering from psychological distress or central sensitisation surely we should attempt to make a positive diagnosis? In 1999, three psychiatrists suggested that various functional somatic syndromes across different medical specialties have more in common than

they do differences.11 I suggest that back pain for which no structural explanation can be found should be included amongst them.

This is important to consider because making a positive psychiatric or psychological diagnosis is as important as making a structural diagnosis. In 2017, Gittins et al described people labelled with fibromyalgia who were submitted to specialist psychiatric assessment. Eighty per cent were found to have a diagnosis for which there was specific treatment.12 It seems likely that a significant number of people with back pain will be similar.

There are many examples of the medical community being resistant to change despite overwhelming evidence of prevailing management being ineffective— the management of peptic ulceration and cholera, to name but two. Faced with a patient with disabling back pain do we revert to the dark ages, label it non-specific and prescribe witchcraft, or do we continue with enlightened thinking, apply Hippocratic principles, and base rational treatment on a diagnosis? The answer seems obvious and yet the status quo is maintained, perhaps by the vested interests of the NSLBP “industry”. This industry includes both service providers and commissioners and it is built on an extremely unsound foundation.

Tim Germon is a consultant spinal neurosurgeon at Derriford Hospital, Plymouth and is the past president of the British Association of Spine Surgeons (BASS).

References 1. Koestler A. The Sleepwalkers. A History of Man’s Changing Vision of the Universe. Hutchinson, London 1959.

2. Germon T, Clifford D, Lee W, Hobart J. The Lancet low back pain series. The Lancet (in press).

3. Keller, A, et al. Effect sizes of non-surgical treatments of non-specific low-back pain. European Spine Journal 2007; 16.11: 1776–1788.

4. Ostendorf, M, et al. Patient-reported outcome in total hip replacement: a comparison of five instruments of health status. The Journal of Bone and Joint Surgery British volume 2004; 86.6: 801–808.

5. Fairbank, Jeremy, et al. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ 2005; 330.7502: 1233.

6. https://www.nice.org.uk/guidance/ng59.

7. Phang Y, Hobart J, Germon T. Spinal nerve root decompression is as effective as total hip replacement (THR) for treating pain. Brit J Neurosurg 2018; 32(3): 313.

8. Germon, T, Singleton W, Hobart, J. Is NICE guidance for identifying lumbar nerve root compression misguided?

European Spine Journal 2014; 23.1: 20–24.

9. Owens II RK, et al. Back pain improves significantly following discectomy for lumbar disc herniation. The Spine Journal 2018.

10. Hussan, F, et al. Discrepancy in surgical and radiological reporting of lumbo-sacral MRI. Orthopaedic Proceedings. Vol. 91. No. SUPP III. Orthopaedic Proceedings 2009.

11. Wessely S, Nimnuan C, Sharpe M. Functional somatic syndromes: one or many? The Lancet 1999; 354.9182: 936–939.

12. Gittins R, et al. The accuracy of a fibromyalgia diagnosis in general practice.” Pain Medicine 2017;1 9.3: 491–498.

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Cervical spondylotic myelopathy

Cervical decompression surgery found to improve gait and function in adult cervical spondylotic myelopathy patients A new study has found that after cervical decompression surgery, cervical spondylotic myelopathy (CSM) patients exhibited improved gait pattern, spatiotemporal parameters, spine and lower extremity range of motion (ROM), and patient-reported outcomes. The study was carried out by Ram Haddas (Texas Back Institute, Plano, USA) and colleagues, and won the First Place Clinical Research Award at the 46th annual meeting of the Cervical Spine Research Society (CSRS; 6–8 December, 2018, Scottsdale, USA). The study was partially sponsored by CSRS and Haddas won the grant seed award for the project in 2017.

DIFFICULTIES WITH BALANCE and gait are two of the most common manifestations of CSM, the authors write.

They mention that patients with CSM have a slower gait speed, prolonged double support duration, and reduced cadence compared to healthy controls.

According to the investigators, surgical decompression has been found to improve clinical outcomes, but conflicting results are apparent when examining function. “To our knowledge,” they write, “there is no literature regarding spinal and lower extremity kinematics, with very limited literature

on the spatiotemporal gait parameters of patients having CSM before and after surgical intervention.”

The main purpose of the study was to explore the level of functional compromise, both objectively and subjectively with patient-reported outcome measures, in patients with CSM. Secondarily, the authors sought to quantify the potential benefit of cervical decompression surgery on the biomechanics of the spine and lower extremities as evaluated by gait analysis.

Haddas and colleagues note that preoperatively, CSM patients

Ram Haddas

demonstrated altered gait parameters compared to controls. Specifically, they found that CSM patients demonstrated slower walking speed (p=0.006) and reduced cadence (p=0.001), longer step time (p=0.013) and double support time, shorter step length and wider step width (p=0.001) preoperatively in comparison to controls. Furthermore, CSM patients had greater ankle ROM (p=0.019), less hip ROM (p=0.050), increased pelvis (p=0.001) and lumbar spine (p=0.049) ROM in the sagittal plane when compared to the control group.

They found that postoperatively, CSM patients demonstrated a faster walking speed (p=0.002), increased cadence (p=0.029), longer step length (p=0.015), and narrower step width (p=0.004). They also exhibited greater knee (p=0.043) and hip ROM (p=0.007), less pelvis (p=0.002), lumbar spine

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(p=0.035), and cervical spine (p=0.044) ROM, and improved clinical outcomes (Neck Disability Index [NDI], Oswestry Disability Index [ODI], and Visual Analogue Scale [VAS]; p=0.001) compared to their preoperative values.

When comparing clinical outcomes, the NDI (p=0.001), ODI (p=0.001), VAS neck (p=0.001), and VAS arm (p=0.001) scores were significantly improved following surgery.

Following cervical decompression surgery, CSM patients not only exhibited improved gait pattern, but also improved spatiotemporal parameters, spine and lower extremity ROM, and patient-reported outcomes. The authors found that three months after surgery, CSM patients did not present with any differences compared to controls beside pelvis ROM (p=0.019).

Haddas and colleagues describe the study as a non-randomised, prospective, concurrent control cohort study of patients with CSM before and after cervical decompression compared to a matched asymptomatic control group.

Twenty five patients with symptomatic CSM underwent clinical gait analysis a week before and three months after surgery. Clinical gait analysis was performed on 30 matched asymptomatic controls as well. Spine and lower extremity kinematics, spatiotemporal parameters, and clinical outcome were measured. A repeated measurement and one-way ANalysis Of VAriance (ANOVA) were used for the statistical analysis.

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Profile

Matthew Scott-Young

As the incoming president of the Spine Society of Australia, Matthew Scott-Young details how his experience as an Emergency Department intern sparked a life-long interest in spine care. He addresses current challenges, warning against the dangers of cost minimisation, and talks about the sense of responsibility he feels towards the next generation, urging aspiring spine surgeons to find a good mentor. Now involved in many aspects of spine care, from surgery and teaching to research and policy, he explains why his surgical role remains the “most rewarding” aspect of the job.

While you knew from an early age that you wanted to be a doctor, what drew you to orthopaedics and later spine surgery in particular?

The attraction to orthopaedics came from my days as an intern in the Emergency Department, where I saw trauma, fractures and spinal injuries. The orthopods would attend, make an assessment, and were decisive. They would take the patients to theatre and make them better. They were pragmatic and, despite what some may say, they were approachable and friendly. Through orthopaedics, I was introduced to the treatment of the spine—stabilising my first cervical spinal trauma as a registrar sparked my love for spinal surgery. When I look back, it was 1988 when technology was starting to get traction, surgeons were starting to get results and evidence based medicine was in its infancy. Even though it sounds like you are treating one thing—the spine—the subspecialty is full of diversity and you are exposed to a multitude of pathologies and treatment modalities. Really, at the time, I could see the potential and future of the treatment of the spine and I was excited at the prospect of being part of that.

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

First and foremost, my father, Norm, a general surgeon and mother, Olive, a registered nurse, were my mentors.

They were instrumental in guiding me through my formative years. I watched my father, a veteran of WWII and the Vietnam War, take care of a regional community in North Queensland as a general surgeon and superintendent of the local hospital. It was the time in the 60’s and 70’s when, if brain surgery was required, the general surgeon performed the surgery. These were times when there would be no doubt a severely injured patient wouldn’t survive a transfer to the big city, Brisbane. My Father’s surgical skills were second to none and watching him in theatre as a teenager taught me that your craft is not about how much you knew but about getting to that higher plane of surgery; a place where your hands are decisive and efficient and when the surgeon can anticipate complications and make adjustments as they go.

Those orthopaedic surgeons I met in Emergency, later became my mentors—David Morgan, John Morris and Tony Blue. They had my back when, as an orthopaedic trainee, my less than diplomatic approach to hospital administrators got me into hot water. Their advice and assistance got me through my training programme. My surgical skills have certainly improved since my training days, but I cannot say my diplomacy skills have matured at the same rate.

Specifically, in relation to my journey towards becoming a spine surgeon, I benefitted from the mentorship of Geoff Askin, Bruce McPhee, John Tuffley, John Lonstein, James Wilson-McDonald, and Jeremy Fairbank. I am also thankful today to many of my peers and brothers around the world who stood with me as we pressed the boundaries in anterior approaches to the spine.

While completing your postgraduate fellowship in spine surgery at the Nuffield Orthopaedic Centre in Oxford, you met some leading surgeons who introduced you to evidence-based medicine. How did this experience shape your career?

Oxford in 1996 was the home of evidence-based medicine, where David Sackett, a Canadian, physician at the John Radcliffe Hospital was already talking about “external clinical evidence and individual clinical experience” when formulating the philosophy of evidence-based medicine in the care of patients. What I found was that my fellowship supervisors at the Nuffield Orthopaedic Hospital, James Wilson-MacDonald and Jeremy Fairbank, were already applying those principles to their practice of spine surgery.

On returning home, like my Father, I found myself setting up practice in a regional area—albeit paradise— the Gold Coast. Coming from Oxford, it was just common sense that I should track the outcomes of spine surgery, so that I could modify my behaviour in the future to maximise a result and minimise the problems. Hence, the collection of patient reported outcomes (PROMs) formed the foundation of my practice back in 1996.

Collecting and reflecting on my individual clinical experience and evidence allowed me to provide patients with well-informed responses about what they could expect, when asking those important questions: how much pain will I lose? How will the surgery help me?

And for how long do the benefits last?

What would you say is your proudest career achievement to date?

I am not sure that I can narrow it to one particular moment. I think for me, overall, my proudest achievement is the understanding of the nuances related to the anterior reconstruction of the spine. So, this is not a single moment or event but about reaching that volume performance moment when, maybe, my Father would look down on me and see something of himself.

What has been the greatest disappointment?

My greatest disappointment is not with any particular procedural failure or implant failure, as I have been lucky enough to follow the right path. My greatest disappointment is when I do not get a patient right or have a poor clinical outcome. There will always be cases of technical success with clinical failures but they are hard for both the surgeon and patient. My goal is to try and work out how to minimise this discrepancy.

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

The most interesting piece of research I have read lately is in relation to the MRI spectroscopy by Nocimed.

This new technology promises to change the paradigm for diagnosis of degenerative spinal conditions and I certainly look forward to understanding its sensitivity, specificity and its utility in clinical practice.

You are involved in many different aspects of spine care, from surgery and teaching to research and policy. Where does this desire to go above and beyond a clinical role come from?

From my point of view, even though I have long left the Australian public system, the traditional place of training for our surgeons, I understand my responsibility towards the next generation of spine surgeons. It is with some considerable pride that I see my fellows reconstructing the anterior spine, achieving disc height, correcting the sagittal balance and correcting deformity—and then returning to their homes and communities around the world. I admit it is hard work, one on one mentorship, every year I question whether to take on another fellow but ultimately, it is my fellows who keep challenging me, keep me on my toes, and keep me relevant.

As to public health policy, I guess I will claim like everyone I was dragged into it reluctantly. The percentage of GDP that goes towards healthcare will vary from

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What do you think are the main challenges facing spine care at the moment? What are the potential solutions?

Without doubt the main challenge facing spine care is dividing up the healthcare dollar. Our patients expect the newest and most advanced treatments and they are told by their governments confidently that they have the “best healthcare system in the world.” But as clinicians we have seen funding being chipped away everywhere we look, mostly under the guise of efficiency, but if we are honest it is for cost minimisation. I think my generation are going to get some unpleasant surprises about what we cannot expect from our healthcare systems as we age.

First, the solution is for governments and insurers to stop the “fake news” about what does not work and own up about what needs to be done to fund our healthcare into the future. Secondly, we must take responsibility for leading healthier lives—more focus and funding needs to be focussed on education and the prevention of chronic disease.

What do you hope to achieve as president of the Spine Society of Australia?

I am looking forward to taking on the role of president of the Spine Society of Australia. The society has grown from what was “the facet club” in 1990 to fast becoming the peak body for those specialising in the management of spine in Australia. The Society is a bridge between neurosurgeons, orthopaedic surgeons, academics and allied health professionals. While our size is dwarfed by the likes of NASS and Eurospine, that has never stopped Australians (and New Zealanders) from boxing above our weight.

As president, I hope to build on what presidents over the last few years have started; building a strong voice in Australia for our patients and our profession. I also want to galvanise our craft group towards recognition of the fellowship trained “spinal surgeon” as a sub speciality, though that journey may take some time.

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

I think one of the most exciting developments will be having a better understanding of the constrained disc replacement. In the past, the discs had too much movement and, of course, we have seen the negative effects of the static fusion. I think we will develop devices that will give some motion but not have the effects of fusion. Such devices could be applied to multiple levels and potentially correct deformity. I envisage this happening over the next 10 to 15 years. country to country but, essentially, it is about 10–15% and that slice of the pie will not get any bigger. Most clinicians are too busy just getting through their day to notice what is going on behind closed doors—we end up being reactive and, usually, by then it is too late and the decision has been made. Australia is at the tipping point over who will control private health care decisions— clinicians or payers (private or public). I see my role in medical politics over the next few years to make sure that when hard decisions need to be made about the future of medicine in Australia clinicians at the coal face have a voice and it is heard.

Is there a role you find particularly rewarding?

I think the role I find most rewarding is actually my surgical role. Being able to unravel the nexus of pain and decide whether surgical strategy is appropriate or not, implementing that strategy and seeing the results.

There is nothing more rewarding than a happy patient.

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

The best advice I can give is what my wife keeps telling our kids—start how you want to finish. To that end, young aspiring surgeons need to find mentors and stick to them like glue. They need to realise that you are going to make some mistakes but persevere, document your outcomes, and modify behaviour accordingly.

Don’t worry about being busy; that will come in time. Certainly, do not worry about the fast cars and luxury homes. Keep your moral compass close when challenging ethical decisions need to be made. Put simply, focus on your patients and on achieving the best outcomes for them and everything else will follow.

What are your interests and hobbies outside spine?

Golf, golf and more golf. Oh, and wine, wine and more wine. But seldom together, if my handicap is to stay single digits!

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Fact File

Qualifications

2014 Certified Independent Medical Examiner 2004 Fellow of the Australian Orthopaedic Association 1995 Fellow of the Rotal Australasian College of Surgeons 1986 MBBS, University of Queensland, Australia

Professional positions (selected)

President Elect, Spine Society of Australia Visiting Medical Officer, Pindara Private Hospital, Queensland, Australia Section Editor—Biologics, The International Journal of Spine Surgery Committee Member; Spine Society of Australia Chief Supervisor; PFET Fellowship, Pindara Private Hospital Spine Fellowship Independent Medical Examiner, WorkCover, Queensland, Australia

Memberships (selected)

Spine Society of Australia; active member North American Spine Society; corresponding member International Society for the Advancement of Spine Surgery Royal Australasian College of Surgeons; fellow

Prizes & awards

April 2016 Kostuik Innovation Award, The incidence of adjacent segment disease and index level revision and outcomes of secondary surgical intervention following single level lumbar total disc replacement, oral presentation, ISASS16, Las Vegas USA. April 2014 Best Paper Award– The Incidence of Retrograde Ejaculation Following Anterior Lumbar Interbody Fusion using rhbmp2 in 376 Male Patients, SSA ASM, Brisbane.

April 2007 Best Clinical Paper – Clinical Results of Two-Level Lumbar Arthroplasty Versus Combined Arthroplasty and Fusion (Hybrid Procedure), SSA ASM, Hobart.

Publications (selected)

Scott-Young M, McEntee, Furness J, et al.

Combined Aorto-Iliac and Anterior Lumbar Spine Reconstruction: A Case Series. IJSS 2018; 12 (3): 328–336 Scott-Young M, McEntee L, Schram B, et al. The concurrent use of lumbar total disc arthroplasty and anterior laumbar interbody fusion: the lumbar hybrid procedure for the treatment of multilevel symtomatic degenerative disc disease – prospective study. Spine 2017; 43(2), e75–e81

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Mar

Patients treated with chronic opioids prior to spine surgery “significantly less likely” to achieve meaningful improvements at one year New results suggest that patients treated with chronic opioids prior to spine surgery are “significantly less likely” to achieve meaningful improvements at one-year in pain function and quality of life; and less likely to be satisfied at one-year with higher odds of 90-day complications, regardless of dosage. The study, authored by Jeffrey M Hills (Vanderbilt University Medical Center, Nashville, USA), was presented at the 46th annual meeting of the Cervical Spine Research Society (CSRS; 6–8 December, Scottsdale, USA). The presentation was awarded the Second Place Resident/Fellow Research Award at the conference.

THE INVESTIGATORS FOUND that of 2,128 patients included in the study, preoperative chronic opioid therapy was identified in 21% and associated with significantly higher odds of not achieving meaningful improvements at one-year in extremity pain (aOR [adjusted odds ratio; 95% confidence interval]:1.5 [1.2-2]), axial pain (aOR:1.7 [1.4-2.2]), function (aOR:1.7 [1.4-2.2]), and quality of life (aOR:1.4 [1.2-1.9]); dissatisfaction (aOR:1.7 [1.3-2.2]); 90-day complications (aOR:2.9 [1.7-4.9]); and postoperative chronic opioid use (aOR:15 [11.4-19.7]). Their results showed that a high preoperative opioid dosage is only associated with postoperative chronic opioid use (aOR: 4.9 [3-7.9]).

In this longitudinal cohort study, the authors aimed to determine one-year patient reported outcomes associated with pre-operative chronic opioid therapy and high preoperative opioid dosages in patients undergoing elective spine surgery. They defined outcomes as satisfaction, return to work, 90-day complications, and post-operative chronic opioid use.

Hills and colleagues used their state’s Prescription Drug Monitoring Program (PDMP) to collect daily morphine milligram equivalents (MME) from nine-

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Pain management

months preoperatively until one year postoperatively.

Patients included had undergone spine surgery between January 2011 and February 2017.

The authors note that patients undergoing spine surgery for degenerative spine disease at the investigators’ institution are enrolled in a longitudinal registry if they are English Jeffrey Hills speaking, above the age of 18, and willing to participate. For this study, patients were excluded if they lacked one-year follow-up data, lived in a different state or had no identifiable record in the state PDMP, had pathologic spine disease (tumour or infection), or presented with less than three months of axial and/or extremity pain.

Hills and colleagues maintain that back pain is the most disabling condition worldwide and over half the patients presenting for spine surgery report using opioids. They note that while preoperative dosage has

been correlated with poor outcomes, published studies have not assessed the relationship of both pre-operative chronic opioids and opioid dosage with patient reported outcomes.

According to the investigators, current literature has thus far been limited to insurance or administrative claims data, small cohorts, or self-reported opioid dosages. Lee et al, for example, collected self-reported pre-operative opioid dosages and found each 10mg increase to be associated with a corresponding decrease in patient reported outcomes at one year after surgery.

Similarly, Wick et al found daily MME of 29 as a threshold for achieving Minimal Clinical Importance Difference for functional patient reported outcomes after spine surgery.

Two studies by Jain et al used commercial insurance data and reported that pre-operative chronic opioid therapy was associated with cost and increased risk of post-operative complications after spinal fusion, but they were unable to report patient reported outcomes.

The present study “addresses a gap in the literature” surrounding the association of pre-operative chronic opioid therapy and dosage with long-term patient reported outcomes after spine surgery, say the authors.

The investigators note certain limitations to their study. For example, using prescription data from their state’s PDMP required exclusion of patients living outside the state, making external validity unclear.

Additionally, while the authors chose validated instruments for pain, function, and quality of life after spine surgery, there are no well-established improvement scores for what defines clinical success.

Hills stressed the need to develop effective strategies for weaning patients on chronic opioid therapy and concluded: “When considered in conjunction with the known dangers of opioids and strong evidence demonstrating no benefit to long-term opioids, our results should substantially narrow the indications for chornic opioid therapy in treating spine pathology.”

SMaRT human neural stem cells found to degrade scar and optimise regeneration after traumatic cervical spinal cord injury Researchers at the University of Toronto (Toronto, Canada) have released “exciting” proof-of-concept data that genetically-engineered SMaRT cells can degrade chondroitin sulphate proteoglycans in vitro and that human neural stem cell grafts can form long axonal processes in the chronic cervical spinal cord injury (SCI) niche. The data were presented at the 46th annual meeting of the Cervical Spine Research Society (CSRS; 6–8 December 2018, Scottsdale, USA) by Christopher S Ahuja (University of Toronto, Toronto, Canada).

ACCORDING TO THE researchers, scar-modifying enzymes can enhance neural stem cell-mediated recovery, however, nonspecific administration via an intrathecal catheter increases the risk of offtarget CNS effects. Ahuja and colleagues in Michael Fehlings’ lab therefore Chris Ahuja aimed to generate a novel, genetically-engineered line of hiPS-neural stem cells, termed Spinal microenvironment modifying and regenerative therapeutic (SMaRT) cells, capable of locally expressing a scar-degrading enzyme to enhance functional recovery without the risk of nonspecific administration.

The researchers found that the scar-degrading ENZYME and fluorescent reporter are expressed by the transgenic SMaRT cells. “Importantly,” Ahuja remarked,

“SMaRT cells retain their human neural stem cell characteristics.” The expressed enzyme appropriately degrades human CSPGs and allows neurons to extend into CSPG-rich regions in vitro. They also found that conditioned SMaRT cell media degrades in situ rodent CSPGs in ex vivo injured cord cryosections.

While blinded behavioural analyses are ongoing, Ahuja noted, an interim histologic analysis of several animals shows that grafted human cells are extending remarkable long (medulla to mid-thoracic) axons through rodent white matter at eight weeks’ posttransplant. The investigators found that the graft further evolves by 32 weeks’ post-transplant demonstrating more numerous, thinner, and longer processes with positive staining for mature neuron markers such as NF200.

Ahuja described how using non-viral techniques, a scar degrading enzyme was genetically integrated into hiPS-neural stem cells under a human promoter and a monoclonal line was generated by fluorescence activated cell sorting. Enzyme expression and activity

was extensively characterised in vitro by biomechanical assays, slot blot, and cell culture assay.

Further to this, T-cell deficient RNU rats with chronic (eight week) C6–7 clip-contusion injuries were randomised to receive (i) neural stem cells, (ii) SMaRT enzyme-expressing neural stem cells, (iii) vehicle control, or (iv) sham surgery (laminectomy alone).

Behavioural assessments are completed to different timepoints post-injury representing stages of chronic human injury with analyses ongoing.

On the significance of the research, Ahuja tells Spinal News International that “currently, no effective regenerative therapy exists for millions of individuals living with chronic spinal cord injuries.

This work shows that human neural stem cells can be bioengineered to express an enzyme capable of breaking down a component of chronic scar.”

He concludes that “while the neurite outgrowth by grated cells is impressive, the bigger question is how to leverage these findings to produce meaningful functional recovery.”

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Technology

VR and simulation: The secret to better medical education and safer surgery?

Daniel Spencer Comment & Analysis Talking to Spinal News International, Daniel Spencer argues that while adoption of virtual reality and simulation represents a “leap of faith” for hospitals, the technology has enormous potential for medical training and presurgical planning.

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rtificial intelligence (AI) and virtual reality (VR) dominated technological headlines in 2018 and the excitement around both shows no sign of abating this year. Whilst riding a roller coaster in our living rooms with a VR headset is exciting, a more practical use for the technology is also emerging as a game changer in medical education and surgical planning.

Preparing surgeons for their first experience in the OR is a difficult task.

Demonstrations on plastic models or cadavers and textbooks can help, but they only go so far. What VR presents in a surgical setting is the opportunity for a trainee to immerse themselves in a procedure in real-time.

The benefits are not just for students, either. The latest simulation technology means that surgeons are better equipped than ever when it comes to preparing for unusual or highly complex procedures.

In an environment where the stakes are so high and the difference between success and failure literally rests on a scalpel edge, the marginal gains represented by technology like this represent a potentially giant leap forward in medical education and surgical planning.

In this article, I am going to take a look at the capabilities of medical simulation technology.

Game changing training

Even if they know every tiny step is being supervised and scrutinised, volunteers are unlikely to be forthcoming for trainee surgeons to practice on. Whilst we might be inclined to take a risk on a great meal from a trainee chef or a cheap haircut, we are not going to do the same for our laparoscopy or knee replacement.

But for health care professionals (HCP’s) to improve, the more time they spend, andmore practice they get in ORroom scenarios the better.

In theory, this is what this technology provides.

Simulation and VR technologies give the HCP an immersive learning

experience, allowing them to learn and make mistakes without severe consequences. This means skills can be honed far quicker than through watching procedures and demonstrations. The professional can get hands on experience much quicker.

Take the tools used. Familiarising themselves with the likes of scalpels, drills and saws is a huge part of life as a surgeon. Building muscle memory and familiarity with these items is key to both a surgeon’s

that users are provided with real-time feedback on how a surgery is going.

Procedures can also be quickly restarted which means that different surgical scenarios can be tested. This level of experimentation would never be permitted (and rightly so) in the real life OR.

Pre-surgical planning

The benefits of simulation are not just available to brand new surgeons undergoing their training. It also gives experienced surgeons the opportunity to practice complex surgeries before the event. Companies like Precision OS have developed a VR platform that caters for surgeons of all levels, allowing experts to practice complex procedures. When practicing, they can choose to work with or without guidance, allowing them to either receive instruction during a procedure or feedback afterwards.

Visualisation and mapping is another exciting use of AI and VR in the pre-surgical phase. Companies like Immersive Touch enable surgeons to transform traditional two dimensional CT and MRI scans into high resolution 3D models. These models can then, using a VR headset, be manipulated to observe from any angle. This gives the surgeon a huge advantage when it comes to planning particularly difficult procedures.

This level of preparation gives the surgeon the ability to improve surgical outcomes. The physician can explain every aspect of a surgery to patients and run through the procedure with the OR technicians, ensuring as

Virtual reality presents the opportunity for a trainee to immerse themselves in a procedure.” confidence and competence. Virtually all the simulators on the market today have life-like tools on hand so the student can get used to handling them. One company taking this one step further are Virtamed who build customised simulators which include custom designed tools. This opens up opportunities for those in training to use a wide variety of surgical implements and also appeals to medical device manufacturers who could demonstrate their products’ benefits in a surgical scenario.

Simulators in this field also give the user a full training experience. Montrealbased OSSimTech are manufacturers of one such simulator. Their technology provides realistic 3D environments for training in open surgery, allowing users to perform a range of different procedures on the knee, spine or certain trauma cases. This is combined with haptic feedback responsive to the surgeon’s touch, making the experience as authentic as possible.

Not only are the simulators providing a platform, they can also give instruction and feedback. OSSimTech have consulted with senior surgeons to develop metrics for training, meaning

smooth an outcome as possible.

In highly complex procedures surgeons appreciate all the help they can get. When margins are as fine as they are in surgery in areas like the spine and brain, the help that the ability to practice and map out the procedure with a model provides is invaluable.

Learning centres have to speculate to accumulate

Unsurprisingly these systems are not cheap and current methods of using cadavers or plastic models are currently seen as a lower-cost alternative for teaching hospitals. However, the benefits of a simulator come from reuse value; if a technology is reliable enough to correctly replicate surgical scenarios, the equipment should pay for itself over a period of time, whilst allowing many more HCP’s to practice procedures and hone their skills.

The fact that a simulator can be set up for many different procedures is also massively advantageous from a cost perspective. Take an example like 3D Systems—they offer simulators for endovascular, arthroscopy, gastrointestinal, laparoscopy and minimally invasive

spine procedures, to name a few, and the simulator can be quickly adjusted to replicate each one. Therefore, in theory, every student in a class could attempt every surgery being discussed without entering the OR. The fact that the simulators also provide feedback opens the door for independent learning which, in the future, could also cut teaching costs.

So yes, the initial outlay may be high, but teaching hospitals that have the funds available as well as a ‘bigger picture’ mindset could reap the rewards, and savings, in years to come.

Issues

As with any early stage technology, simulation and VR is not perfect. Detractors argue that, if you are going to try and replicate surgery, then it has to be an exact, perfect replica.

Because if it is not then that surgeon is not going in as prepared as he or she should be. In fact, if something happens in the real-life OR that did not occur in the simulation then practitioners could become flustered, as if they were over prepared for a different scenario. And whilst some of what we are seeing is jaw dropping, it is still impossible to truly replicate the feeling, emotion and pressure of surgery.

That being said, it is important to remember that HCP’s will not only be taught by these simulators and will continue to take on board the advice and knowledge of senior physicians. Simulators will not handle the entirety of the teaching process.

The biggest stumbling block for simulators like this is likely to be adoption. The technology is amazing, but for it to take off globally it depends on leaders from major teaching hospitals committing to it. This means making a significant investment into a brave new world which would represent a new way of teaching and instruction to what has been carried out for decades. And whilst medical educators having to adapt to new technology is nothing new—we are used to hearing about developments every day—fundamentally changing the way in which teaching is carried out is another step altogether.

Potential

In conclusion, VR and simulation has massive potential for medical education.

I have seen first-hand the benefits these systems provide and how much they are turning heads in the medical space. So, is it a matter of time before these systems become commonplace in every hospital (that can afford it) and medical school around the world?

Immersive Touch recently said that “virtual reality is the next biggest game changer for medicine”. If this is true then surely those who are willing to take the leap of faith and become early adopters of this technology will be richly rewarded in the future.

Daniel Spencer is a business manager at Charlton Morris (Leeds, UK), an executive search firm specialising in orthopaedics, spine and simulation.

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Minimally invasive surgery

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Minimally invasive placement of pedicle screws may lower incidence of proximal junctional kyphosis A recent study found that using a minimally invasive technique (MIS) for the placement of pedicle screws at the upper instrumented vertebra had a trend towards a lower incidence of proximal junctional kyphosis (PJK) and revision surgery for proximal junctional kyphosis at two years. The results were presented by Floreana Kebaish (John Hopkins University, Baltimore, USA) at the 53rd annual meeting of the Scoliosis Research Society (SRS; 10–13 October, 2018, Bologna, Italy).

THE INVESTIGATORS FOUND that while the rate of proximal junctional kyphosis at two years was low overall, at 17% across all patients (6/35), it was found to be higher for patients who had undergone open surgery than for a group which had been treated using a minimally invasive technique. The rate for the open group was 20% (4/20), compared to 13% (2/15) among the MIS patients. Kebaish and colleagues noticed the same trend in the rate of revision surgery for proximal junctional kyphosis, which at two years was 11.4% across all patients (4/35). For the open group this figure was 15% (3/20) and for the MIS group it was 6.7% (1/15).

According to the authors, the study was carried out in response to a 30% rate of proximal junctional kyphosis in posterior spinal fusions. They note that intact soft tissue structures are “equally important” to bone structure in supporting the alignment of the spinal column and that the disruption of the posterior tension band is currently considered to be one of the main

contributors to proximal junctional kyphosis incidence.

They hypothesise that using the MIS technique at the upper instrumented vertebra to preserve the posterior tension band may decrease the incidence of proximal junctional kyphosis.

Kebaish and colleagues included adult spinal deformity (ASD) patients undergoing posterior instrumented fusion from the lower thoracic-spine to the sacrum in the study. They excluded osteoporotic patients requiring additional vertebral augmentation, among others. The average age of the MIS group was 66.5 years and for the open group, 65.2 years. There were five male and 10 female patients in the MIS group, compared with eight and 12, respectively, in the open group.

According to the investigators, the prospective randomised study included 42 patients who were randomly placed into MIS and open surgery groups.

Six patients were lost to follow up and one patient died.

Thirty five patients completed the two year follow-up, comprising 15 from the MIS group and 20 from the

There was a two times higher rate of proximal junctional kyphosis in the open surgery group when compared to the minimally invasive surgery group.”

open group. Patient data were collected preoperatively, and at four points postoperatively: immediately after surgery, after six weeks, six months, and at two years.

The investigators were looking at radiographic data, including DEXA scans, surgical data, demographic data, complications, and health-related quality of life data.

Kebaish noted that during the open technique, the spine was exposed posteriorly from the upper instrumented vertebra to the sacrum and pedicle screws were then placed using an open free-hand technique at all levels. During the MIS procedure, the upper instrumented vertebra was not exposed. The instrumentation was placed subcutaneously under fluoroscopy and soft tissues at the upper level were preserved.

The authors report five major and 13 minor complications in the MIS group, compared to six major and 17 minor complications in the open group. In the open group, there was one incidence of neurologic deficit (tib ant weakness) and one of nonunion requiring resuscitation, compared to no incidence of either in the MIS group. Conversely, there were two incidences of a moderate cardiac event in the MIS group, of which none occured in the open group.

Kebaish concluded that there was a two times higher rate of proximal junctional kyphosis and a three times higher rate of revision for proximal junctional kyphosis in the open surgery group when compared to the MIS group, results which were “not statistically significant”.

Kebaish suggested that the relatively small sample size “may have contributed to this” and announced that the investigators are continuing to add more patients to the study and follow them up for a longer period of time.

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Enhanced recovery protocol reduces opioid use in spinal surgery patients A novel enhanced recovery after surgery (ERAS) protocol developed by Penn Medicine (Philadelphia, USA) for patients undergoing spinal and peripheral nerve surgery significantly reduced opioid use. A new study published in the Journal of Neurosurgery: Spine showed that when an ERAS protocol was employed—which optimises patients’ surgical care before, during, and after surgery, including patient education, post-operative medications, and recovery plans—fewer patients needed pain medications one month after surgery.

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early 75% of patients at Penn Medicine who undergo spinal surgeries are opioid naïve—patients who are not chronically taking opioids on a daily basis—putting them at an increased risk for dependency following surgery. Previous studies have also shown that up to 7% of all patients who undergo spinal surgeries continue to take opioids one year after surgery. Part of the ERAS protocol at Penn includes a personalised, safe, and effective pain management plan to help prevent opioid dependency, which has rapidly become a public health crisis in the USA. “ERAS protocols engage each aspect of the patient’s surgical journey to improve clinical outcomes and optimise a safe recovery,” said lead author and principal investigator Zarina S Ali, an assistant professor of neurosurgery and neurosurgical ERAS physician lead at the Perelman School of Medicine at the University of Pennsylvania (Philadelphia, USA). “This novel approach allows a framework for addressing pain management in a responsible and effective manner while dramatically reducing opioid use during and after surgery.”

This prospective study included two groups who underwent elective spine or peripheral nerve surgery at Penn: 201 patients in the ERAS group treated between April and June 2017 and 74 patients who underwent

traditional surgical care between September and December 2016. Preliminary findings were presented at the American Association of Neurological Surgeons 2018 Annual Meeting in May. The present paper represents the full results.

Researchers found that use of intravenous opioid medications via patient-controlled analgesia—known as a pain pump—was nearly eliminated in the ERAS group (0.5%) compared to over half of spinal surgical patients in the control group who relied on patientcontrolled analgesia. After one month, a smaller subset of patients in the ERAS group were using opioids (38%) compared to patients in the historical control group

This novel approach allows a framework for addressing pain management in a responsible manner while reducing opioid use during and after surgery.”

(53%). Despite this difference, pain scores among each group were similar, suggesting PCA was not necessary in this population and that the ERAS pain management protocol, which relies on the use of both opioid and non-opioid medications, was effective in achieving appropriate pain control.

ERAS protocols involve coordination among the entire clinical team—including the surgeons, anaesthesiologists, nurses, and outpatient staff—so patients can recover safely and with attention to all aspects of their care, not just the surgery. Protocols include standardised ways to educate patients on the procedure before the surgery along with consultations with specialists in primary care, pain management, nutrition, and sleep medicine, where applicable. Other efforts include smoking cessation and drinking liquid carbohydrates such as sports drinks prior to surgery.

ERAS also includes a robust multi-modal pain management protocol with judicious use of opioids only as needed. The protocol also calls for the patient to be up and moving regularly (three to five times per day) starting the day after surgery as this can improve blood flow and encourage healing.

“Easing opioid use after surgery is a daunting task, but the addition of non-opioid agents, such as acetaminophen, helps mitigate the need for traditional, opioid-heavy pain management. This approach may have profound implications in limiting the risk of chronic opioid dependency in patients following spine surgery,” Ali said.

While other ERAS protocols have been effective in the orthopaedic, urology, and colorectal surgery fields, this is the first to be successfully implemented for neurosurgery patients in a comprehensive programme.

Additionally, patient engagement with the ERAS protocol was facilitated through a Penn Center for Innovation pilot programme, “Engaged Recovery at Penn,” which utilised a text-messaging system to encourage ERAS behaviors for patients.

Increased radiation but “no benefits” in pedicle screw accuracy with navigation A recent study found no improvements in pedicle screw accuracy but increased radiation using intraoperative computed tomography (CT)-based navigation compared to a freehand technique in idiopathic scoliosis surgery. The study was carried out by Wiktor Urbanski (Wroclaw University, Wroclaw, Poland) and colleagues and recently published in the journal Clinical Orthopaedics and Related Research. The paper was presented by Urbanski at the 53rd annual meeting of the Scoliosis Research Society (SRS; 10–12 October, Bologna, Italy).

Wiktor Urbanski

THE INVESTIGATORS DID not observe any benefits to pedicle screw placement with CT-based navigation in patients with moderate idiopathic scoliosis undergoing primary surgery, however the patients experienced “significantly greater” exposure to radiation. While navigation reduced significant screw misplacements, Urbanski suggested this was “potentially

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Pain management

symptomatic” and there were no grade three pedicle screws in the navigated group. He noted that “caution is essential” to balance surgical safety and the adverse effects of increased radiation associated with CT-based navigation.

According to the authors, 96.3% of pedicle screws in the freehand group were properly positioned, compared to 95.8% in the navigation group. This included 315 (82.03%) described as grade zero and 55 (14.32%) as grade one in the freehand group, compared to 374 (82.92%) and 58 (12.86%), respectively, in the navigated group. Not all grade two screws were repositioned, however “most of them” were.

Only the freehand group contained grade three pedicle screws, all four of which were repositioned. Grade three screws occurred only in the upper and mid thoracic spine. Reduced accuracy was noticed in the upper thoracic spine (T1-T5), in both groups. No differences in accuracy between the navigated and freehand groups were noted (p=0.21) in

the upper thoracic spine.

Urbanski noted that the navigation group usually has two times more O-arm 3D scans than the freehand group, which in this study was reflected in higher radiation levels. With 2D imaging, however, patients were exposed to higher radiation in the navigated group.

The investigators note that 49 patients were treated operatively for progressive idiopathic scoliosis in the Department of Orthopaedics at University Hospital Wroclaw (Wroclaw, Poland). Those included had idiopathic curves only, with a magnitude between 45 and 90 degrees, and had never undergone spinal surgery before. The two groups did not differ in age, sex, or magnitude of deformity.

In total, 835 pedicle screws were inserted by two surgeons. In 27 of the 49 patients, 451 screws were inserted with the aid of navigation based on 3D images obtained during surgery by an O-arm. In the other 22 patients, 384 screws were inserted using a freehand technique.

Two observers were not involved

in the treatment and instead evaluated screw position. The pedicle breach was described on CT scans. Grade 0 was defined as no pedicle violation, grade 1 as a breach of 22m or less, grade 2 a breach of 2–4mm, and grade 3 a breach of more than 4mm. The comparison of the results was made between navigated screws and freehand.

The investigators aimed to compare the accuracy of two methods of pedicle screw placement in patients with idiopathic scoliosis; intraoperative 3D image navigation and a freehand technique. They also wanted to assess the radiation dose for the patients in both methods.

Pedicle screws are crucial in the surgical treatment of spinal deformity for a number of reasons. Urbanski noted a few: excellent mechanical conditions, improvement and maintaining of correction and a good long-term outcome, associated with solid fusion.

However, he pointed out that the technique of proper positioning of the screws is “demanding,” particularly in spinal deformities.

The navigation systems based on intraoperatively obtained 3D imaging were developed with the expectations of an increase in accuracy, however the authors allude to a number of concerns regarding 3D-based navigation, such as radiation, insufficient data available confirming superiority of navigation above other techniques, and costs of the necessary equipment.

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Market watch

Product News

FDA approval for M6-C artificial cervical disc

The US Food and Drug Administration (FDA) has approved the M6-C artificial cervical disc (Orthofix Medical) for patients suffering from cervical disc degeneration. The artificial disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018.

The M6-C artificial cervical disc has been developed to replace an intervertebral disc damaged by cervical disc degeneration. Designed to restore physiologic motion to the spine, the M6-C disc is indicated as an alternative to cervical fusion. The M6-C artificial cervical disc preserves motion by restoring biomechanical function at the treated level after native disc removal and potentially reduces subsequent degeneration of adjacent vertebral segments.

Pre-market approval was based on clinical data from a US Investigational Device Exemption (IDE) study that evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Patients in the study presented with degenerative cervical radiculopathy requiring surgical intervention, and confirmed clinically and radiographically at one vertebral level from C3 to C7.

At 24 months, 90.5% of patients who received the M6-C disc demonstrated a meaningful clinical improvement in the Neck Disability Index. Additionally, a meaningful clinical improvement in arm pain score was seen in 91.2% of the M6-C patients compared to 77.9% in ACDF patients. This same meaningful improvement was seen in neck pain scores with 90.5% of patients who received the M6-C disc compared to 79.9 % in patients who underwent the ACDF procedure.

Prior to surgery, 80.6% of the M6-C disc patients and 85.7% of the ACDF patients were taking some type of pain medication for the treatment of their cervical spine condition. At 24 months, 14% of the M6-C disc patients were still taking some type of pain medication compared to 38.2% of the ACDF patients.

The prospective, non-randomised, concurrently controlled, multicentre clinical trial was conducted at 23 sites in the USA. Orthofix expects to release the M6-C artificial cervical disc in 2019 through a controlled, limited market launch in the USA accompanied by an extensive training and education curriculum for surgeons. The M6-C artificial cervical disc received CE mark approval for distribution in the European Union and other international geographies in 2006, and there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the USA to date.

Sirakoss granted CE mark for synthetic bone graft substitute

Sirakoss has been granted CE mark clearance in the European Union (EU) for Osteo3, a novel nanosynthetic bone graft substitute designed to improve patient healing, offering surgeons a more advanced solution for repairing bone fractures.

Based on proprietary nanoporous technology, Osteo3 consists of an inorganic matrix that is completely reabsorbed into the bone. The surface chemistry of Osteo3 is designed to catalyse bone regeneration following a fracture or to support the skeletal system after corrective surgery of a degenerative or deformity condition. Sirakoss is developing further generations of Osteo3 to facilitate intraoperative ease of use by surgeons.

Under its CE mark, Osteo3 is intended to be used as a bone graft material for filling voids or gaps of the skeletal system. Osteo3 can be used alone or in combination with autograft (patient’s own bone), or allograft (donor tissue).

“We designed Osteo3 to address an increasing demand for a bone graft substitute that has the efficacy of autograft but overcomes the wellreported problems of donor site pain for a significant number of patients,” explained Iain Gibson, cofounder and director of research and development at Sirakoss and professor of Acellular Regenerative Medicine at Aberdeen University (Aberdeen, UK).

He continued: “Our initial studies have confirmed both of these important aspects with our novel, fully nanosynthetic material. We are also working on the next generation of Osteo3, which will provide additional benefits to surgeons, in particular little or no prep in the surgical suite.”

New implants released for StabiLink Interlaminar System

Three new StabiLink Dual Lamina Implants (Southern Spine) have been released. Alan H Daniels, associate professor of Orthopaedic Surgery at The Warren Alpert Medical School of

Brown University (Providence, USA) has specifically used the StabiLink Dual Lamina constructs as an adjunct to long segment, pedicle screw deformity constructs to help prevent proximal junctional kyphosis (PJK) and proximal junctional failure (PJF).

Daniels has recently published a case study titled “Severe Sagittal Imbalance Correction” where he uses the StabiLink Dual Lamina Implant to create a transition zone at the upper instrumented vertebra (UIV) and UIV+1. In the case study, Daniels states, “For PJK prevention, an interlaminar flared construct (StabiLink Dual Lamina, Southern Spine, Macon, USA) was placed. This strategy may be more robust in some cases than ligamentoplasty, and is easily and rapidly applied.”

Daniels’ clinical data will be presented at the upcoming International Society for the Advancement of Spine Surgery (ISASS) conference 3–5 April in Anaheim, USA. The data highlight recent clinical outcomes utilising the StabiLink Dual Lamina Implant on 16 deformity patients for PJK prevention with follow up ranging from two months to over one year.

“We are very excited about the potential that the StabiLink Dual Lamina System can provide these extremely challenging clinical cases,” stated David C Field, CEO of Southern Spine. “We believe that the new StabiLink Thoracic sizes are an excellent choice to provide a ‘softer landing’ between the stiff pedicle screw construct and the un-instrumented spine”. Field further stated, “We have recently been issued three additional US patents, bringing our IP portfolio to 13 issued US and International Patents to protect our unique StabiLink MIS Interlaminar Spinal Fixation System.”

Medtronic announces US commercial launch of Mazor X Stealth Edition

The first US patients have been treated with the Mazor X Stealth Edition (Medtronic) for spine surgery following its commercial launch. The technology offers a procedural solution for surgical planning, workflow, execution and confirmation. The system was first used at Norton Healthcare in Louisville, USA, and Reston Hospital Center in Reston, USA. “It is rare that huge sectors of technology such as robotics and navigation merge into a sole platform as found in the Mazor X Stealth Edition.

Combined, these may provide more predictable and reliable execution of our procedure workflows,” remarked Jeffrey Gum, orthopaedic spine surgeon at Norton Leatherman Spine.

Codeveloped between Medtronic and the recently acquired Mazor Robotics, the Mazor X Stealth Edition incorporates Stealth software technology into the Mazor X robotic-assisted surgery platform to deliver workflow predictability and flexibility through realtime image guidance, visualisation and navigation informed by interactive 3D planning and information systems.

“The marriage of robotics and

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navigation represents the future of computerised planning and execution in spine surgery. Robotics and navigation have both been shown to improve accuracy and precision in spine surgery,” commented Christopher Good, spine surgeon at Reston Hospital Center, director of Scoliosis & Spinal Deformity and president of The Virginia Spine Institute.

He continued: “The Mazor X Stealth Edition is a revolutionary new technology that uses cutting-edge software to plan the surgical procedure, then uses a robotic arm to guide implants and instruments through the steps of the surgical procedure with precision, while simultaneously using real-time imaging feedback to ensure the plan is being carried out as desired.”

The Mazor X Stealth Edition was cleared by the US Food and Drug Administration (FDA) in November 2018. The system is now available in the USA and is expected to launch in key regions throughout the year.

FIREFLY pedicle screw navigation system granted CE mark

Mighty Oak Medical has received CE mark clearance for its patient-specific, 3D-printed FIREFLY pedicle screw navigation system, extending its use into the European market. The technology is already available in Australia and New Zealand, and has been approved for use in the USA by the US Food and Drug Administration (FDA).

Unlike many other navigation systems, FIREFLY does not require an upfront capital expenditure and is single-use and scalable. It features concierge presurgical planning by trained engineers, autoclavable bone models, predetermined screw sizing, surgeon-approved preselected trajectories, an intraoperative plan, and 3D-printed, patient-specific guides to mechanically constrain the drill and tap to follow preselected trajectories.

Furthermore, the device has proven

FIREFLY 3D printed bone model

to be highly accurate and limit intraoperative radiation exposure. The system does not disrupt surgical flow and is designed to increase operating room efficiency. It is also the only patientspecific pedicle screw guide indicated for use in paediatric patients.

FIREFLY technology should also be able to help hospitals faced with scheduling conflicts for their current navigation systems. By being open platform and compatible with essentially all currently cleared pedicle screw systems, these patented 3D-printed patient-specific guides are an exciting new navigation option.

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Product News Speaking exclusively to Spinal News International, Heidi Frey, Mighty Oak Medical president, commented on the significance of the CE mark: “It is an opportunity for us to expand into other markets where there is clearly a need for this type of navigation solution. We are already in Australia and New Zealand and are very eager to go to Europe. A number of surgeons there have expressed a high interest in using the technology, so the fact that we can now work with them and others is really exciting.”

Brent Ness, chief operating officer of the company, assessed the benefit of the FIREFLY technology to spine surgeons: “FIREFLY reduces radiation, improves accuracy, and improves efficiency”, all of which contribute to enhanced patient safety.

Frey added that the technology is “intuitive and easy-to-use”.

Both Frey and Ness emphasise a number of advantages to the FIREFLY technology over its rivals. According to Ness, the prevailing model of navigation is “complex” and typically requires an upfront capital expenditure, which Mighty Oak Medical decided was “counterintuitive”, given the already complex nature of spine surgery. FIREFLY represents a “simplification of the process” and also a more affordable option, owing to the disposable nature of the system.

A EOG-based HMI wheelchair could help spinal cord injury patients to be more independent

FOR THE FIRST time, investigators have developed an electrooculogram (EOG)-based human-machine interface (HMI) wheelchair that has a robotic arm.

They report in the Journal of Natural Engineering that, by using this novel wheelchair, five patients with severe spinal cord injuries were able to pick up a bottle from a table and drink from it (via a straw).

Qiyun Huang (Center for Brain Computer Interfaces and Brain Information Processing, South China University of Technology, Guangzhou, China) and others write that prior studies have demonstrated the effectiveness of

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Market insights

HoloSurgical announces first surgical procedure utilising ARAI system

A successful first-in-human surgical procedure utilising ARAI, an augmented reality and artificial intelligencebased surgical navigation system (HoloSurgical) has been carried out.

The ARAI is an advanced digital surgery platform that combines 3D visualisation, data analytics, and machine learning to improve outcomes, reduce surgical time, and decrease surgical complications. The clinically-tested ARAI surgical guidance system provides

real-time, patient-specific, 3D anatomical visualisation for presurgical planning, real-time intraoperative guidance, and post-surgical data analytics.

The case, a lumbar decompression and fusion procedure, was performed on a 61-year-old male suffering from severe back and leg pain as a result of a grade 2 spondylolisthesis, a degenerative spinal condition resulting in spinal stenosis. The surgery was performed in a minimally invasive fashion and the ARAI system was flawlessly incorporated into the surgeon’s regular workflow.

During the procedure, the ARAI system automatically identified relevant anatomical structures and colour coded them, presented a treatment plan, and guided the surgeon to place the implant using augmented reality-based 3D visualisation.

Ulrich medical USA announces entry and first global implantation of expandable implant technology

participants—consisting of 10 healthy controls and five patients with severe spinal cord injuries—to perform three different experiments. One of these was designed to simulate a common event in daily life and the participants had to move “from a random position to reach a table, also randomly located in the room, selecting a target bottle on the table and grasping it to drink water from a straw”.

Additionally, the participant had to navigate around up to seven obstacles to reach the table (which had three bottles of water on it). According to Huang et al, all participants completed the table experiment without any collisions and there were no unsuccessful grasps.

The healthy controls completed one trial in an average of 247 seconds with 26 operations vs. 315 seconds and 38 operations for the patients with severe spinal cord injury. Furthermore, no emergency stop was recorded in the test.

Another experiment was to evaluate the ability of the EOG-based HIM system to differentiate between an intentional blink and unintentional blink—Huang et al observe a challenge

of EOG-based systems is to avoid “false-positive commands caused by unintentional blinks”. They explain their system has been designed to overcome this challenge by assessing the amplitude of an EOG-detected blink and only recognise a blink as intentional if it was above a certain amplitude. “If an unintended blink was falsely recognised as an intended one, the verification process was used to prevent any false positive common in this case. Only when the user raised his/her eyebrows to verify the preselection result would the corresponding command be triggered,” the authors explain. The experiment found that the probability of an unintended blink being recognised as an intentional one was 7.7% for the healthy controls and 17.3% for the spinal cord patients.

Concluding, Huang et al state their findings show their proposed EOGbased HMI can “provide sufficient precision control to integrate a wheelchair and a robotic arm, which could help patients with spinal cord injuries in daily life”.

HoloSurgical ARAI system

EEG/EOG-based wheelchair systems and robotic arms but note “as far as we know, these two devices have not been integrated together and controlled by an EEG/EOG-based HMI”. Furthermore, they comment that the main challenge of integrating the two systems is that the resultant system would need to allow the user to “effectively drive and accurately stop the wheelchair such that the randomly located object is within reach of the robotic arm, which requires decimetre-level positional precision and accurate direction control”. “Until now, it has not been reported that EEG/EOGbased wheelchair systems can provide such precision control,” Huang et al observe.

Therefore, in the study, the authors used a “novel high-precision EOGbased HMI” that is designed to translate two types of eye movement (blinking and eyebrow raising) into various commands. They report: “For the wheelchair, the positional prevision can reach decimetre-level and the minimal steering angle is five degrees. For the intelligent robotic arm, shared control is implemented based on the EOG-based HMI, two cameras and the arm’s own intelligence”.

Huang et al asked the study

In a recent press release, Ulrich medical USA announced the market entry of a vertebral body replacement device which is the company’s flagship technology in the US spine implant market.

According to the press release, the Solidity Vertebral Body Replacement (VBR) device recently received US Food and Drug Administration (FDA) clearance and the world’s first implantation of this titanium implant was performed in Palm Springs, California on 28 December, 2018 by neurosurgeon Blake Berman, section chief division of Neurosurgery, assistant professor of Neurosurgery, and medical director of the Spine Program at the Institute of Clinical Orthopedics and Neurosciences at Desert Regional Medical Center, Palm Springs, USA. Used for the surgical reconstruction of defects of the spine, the Solidity implant consists of a main centre piece with 625 unique end cap configurations available in one optimised set. A wide range of implants can be used to match unique patient anatomy and restore height and sagittal balance for spinal correction.

The design of the Solidity VBR allows end caps to be attached in a full 360 degree orientation on a Solidity centre piece. This maximises the range of device access to support any surgical approach.

BIBA Briefings BIBA Briefings is a new platform that provides in-depth analysis of the latest market intelligence from BIBA MedTech Insights, reviews the latest technology developments, and looks at pipeline developments.

For more information about BIBA Briefings or BIBA MedTech Insights, please contact Merveille Anderson merveille@bibamedical.com

22

Mar

Industry News Medtronic completes acquisition of Mazor Robotics

It was recently announced that Medtronic has completed the acquisition of Mazor Robotics. The total value of the transaction is reported at US$1.7 billion, or US$1.3 billion net of Medtronic’s existing stake in Mazor and cash acquired.

Under the terms of the agreement (announced 20 September, 2018), Mazor shareholders will receive US$58.50 per American Depository Share, or US$29.25 per ordinary share, in cash. The transaction ranks among the largest orthopaedic deals completed in 2018.

Medtronic believes robotic-assisted surgery can play a transformative role in refining procedures, reducing variability and impacting procedural outcomes in spine surgery. The Mazor X Stealth Edition—a codevelopment effort between Mazor and Medtronic—was recently cleared by the US Food and Drug Administration.

This new system incorporates StealthStation software into the Mazor X robotic-assisted surgery platform—

leveraging the power of two technologies to deliver procedural predictability and flexibility through real-time image guidance, visualisation and navigation informed by interactive 3D planning and information systems.

The transaction is expected to be modestly dilutive to Medtronic’s fiscal 2019 adjusted earnings per share, but given the current strength of Medtronic’s business, the company expects to absorb the dilution. Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital (ROIC) by year four, with an increasing contribution thereafter.

SpineSource acquires French medical device technology SpineSource has acquired the intellectual property assets of two spinal implant systems from Kisco International (France).

The acquisition includes the L-VARLOCK expandable lumbar cage that SpineSource has marketed, sold and distributed in the USA since 2016. The acquisition also includes other unique

medical devices that SpineSource plans to submit to the US Food and Drug Administration for potential clearance later this year.

With the use of supplemental fixation, the L-VARLOCK expandable lumbar cage provides spine surgeons an interbody fusion device that can be expanded from any range of zero to 24.5 degree of angle, and from zero to 7.1mm of expansion within the disc space.

SpineSource was founded in 2004, becoming the exclusive distributor for Ulrich Medical GmbH and then was a founder of Ulrich Medical USA in 2007. In 2008, SpineSource launched expandable PEEK and articulating interbody fusion devices from Advanced Medical Technologies, AG which was acquired by Medtronic in 2012.

Kaia Health raises US$10 million in Series A funding

Kaia Health has raised US$10 million in a Series A round led by Balderton Capital. The investment will be used to support Kaia Health’s US rollout and further clinical studies.

Kaia Health develops machine learning and computer vision technology and works with medical experts to create a home-based, affordable and clinicallyvalidated alternative to painkillers, delivered through a smartphone. The company’s back pain app offers users

a daily plan which features physical exercises, relaxation techniques and medical educational content.

Additionally, therapy can be tailored for each user via a proprietary algorithm which adapts the exercise programme to that individual’s input.

With back pain being one of the leading self-reported medical issues in the world, proven digital alternatives to painkillers cannot come soon enough. In the USA alone the condition is estimated to affect 100 million people a year and is the number one reason why people are prescribed painkillers. The growing use of opioid-based painkillers has driven reliance on such drugs in the USA to epidemic levels.

Meanwhile, in the UK, 30% of all general practitioner appointments are musculoskeletal-related, costing the National Health Service at least £5 billion a year. Reducing the need to prescribe painkillers and the number of MSK interventions is not just a beneficial outcome for patients, but it will also release resources for healthcare institutions to use elsewhere.

Kaia Health is a member of the Digital Therapeutics Alliance, an association of international manufacturers for digital therapeutic products which works to expand access to high-quality, evidencebased digital therapeutics to improve outcomes.

Calendar of events 26–28 March 2nd Combined Meeting with NASS, SOSSOP, APSS, OASAC-SAARC and POS Lahore, Pakistan www.spine.org

3–5 April International Society for the Advancement of Spine Surgery (ISASS) 19th Annual Conference Anaheim, USA www.isass.org

3–5 April British Association of Spine Surgeons (BASS) 2019 Brighton, UK

2–3 May EUROSPINE Spring Speciality Meeting Frankfurt, Germany

5–7 June 20th EFORT Congress Lisbon, Portugal

www.eurospinemeeting.org

www.congress.efort.org

15–18 May 8th Annual Global Spine Congress Toronto, Canada

1–5 July NSpine 2019 London, UK

www.gsc2019.org

www.nspine.com

22–24 May 35th Annual meeting CSRS-Europe Rome, Italy

17–20 July 26th International Meeting on Advanced Spine Techniques Amsterdam, the Netherlands

www.csrs-europe-congress.com

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

24–28 September EANS 2019 Dublin, Ireland

www.srs.org/imast2019

www.eans2019.com

25–28 September NASS Annual Meeting Chicago, USA www.nassannualmeeting.org

www.spinesurgeons.ac.uk

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Market watch

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