Spinal News International Issue 49

Nov

Issue

18 49 Todd Albert: Prioritising physician well-being

Page 6

Christopher Bono: The rise of predatory publishing

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Costs curbing the rise of robotics in spinal surgery

The era of routine robotic-assisted spinal surgery is on the horizon. Despite the hype, however, there remains little market penetration, with affordability and the degree of valueadded by such technology representing significant barriers to complete disruption of standard practice.

Donna Ohnmeiss:

Profile

Page 12

Augmented reality surgical navigation technology enables high accuracy pedicle screw placement A recent study has found new technology utilising augmented reality surgical navigation can be clinically used to place pedicle screws, enabling both high accuracy and an acceptable navigation time. The results were presented by Gustav Burström, Karolinska Institutet, Stockholm, Sweden, at the Eurospine 2018 annual meeting (19–21 September, Barcelona, Spain).

I

n a recent literature review published in Spine, Srinivas Prasad (Thomas Jefferson University, Philadelphia, USA) concluded: “It is no longer a question of whether robotics has a role in spine surgery, but rather how and when.” Advantages of robotics include improved accuracy and consistency, and many have postulated that robotics could render complex spinal surgeries as easy as the simplest spine operations, reducing human error and surgical morbidity. However, many barriers remain before the use of robotics in spinal surgeries becomes routine.

Surgical applications for robotics truly emerged in the 1980s, with the adaptation and subsequent adoption of industrial robots. In 2001, Mazor Robotics (Caesarea, Israel) launched the first surgical robot specifically targeting applications in spinal surgery. The company released SpineAssist in 2004. Today, there are a limited number of spine robotic systems: Mazor X and Renaissance (both Medtronic, which acquired Mazor in Autumn 2018), Excelsius GPS (Globus Medical), ROSA (Zimmer biomet, which acquired the ROSA developers Medtech in 2017), and the recently introduced robotic offering from Chinese robots company Tinavi Medical Technology.

Speaking to Spinal News International, Vikas Patel (Spine Center, University of Colorado Hospital, Aurora,

USA) hypothesises that the next technological leap for robotics in spinal surgery will potentially come from combining the capabilities of robots currently used in gynaecology, urology, and general surgery. He explains, “The next real leap will be in the ability of robots to safely handle soft tissues. In spine especially, we need them to be strong and stable when placing screws, but gentle enough to retract a nerve or work around the spinal cord. Some of this ability can come with ‘no fly zones’ to protect the nerves, but the real leap will be when they can gently handle the soft tissues the way a surgeon would. Then they might even be able to help suture the incision—that would be a huge benefit!”

Today’s robotic offerings in the spinal space function as guidance devices. They help line up channels and cannulas to correctly place pedicle screws or other instruments within the patient anatomy. Addressing assembled delegates at the North American Spine Society (NASS) annual meeting (26–29 September, Los Angeles, USA) concerning the integration of robotics into the operating room, Prasad explained how the machines work: “There are two principle modules, and of course navigated instruments as well. There is the platform with the robotic arm itself, with a screen that is sterilely wrapped that the surgeon can manipulate and plan on Continued on page 2

WHILE BOTH VIRTUAL reality and augmented reality have the remarkable ability to alter the user’s perception, the immersive experience of the two can dramatically differ. Unlike virtual reality, which creates a simulated environment, augmented reality overlays digital elements into the real world. In the case of spine surgery, these digital elements are superimposed onto the patient’s anatomy.

Burström acknowledged the recent progression of surgical techniques, “Today we see a number of trends in spine surgery; image-guided surgery and navigation is widely used and widely studied, and [alongside] those, 3D imaging in the operating room is on the rise.”

He noted that the literature depicts a wide variation of accuracies reported for pedicle screw placement. In meta-analyses, many studies report superiority for navigation compared to free-hand.

However, this finding was not reported by all studies and cannot be extended to all indications.

For these reasons, Burström and colleagues aimed to study a specific solution to navigation and examine how it performs in complex spinal procedures. The study was performed in a hybrid operating room with an integrated augmented reality surgical navigation system encompassing a surgical table and a motorised flat detector C-arm with intraoperative 2D and 3D capabilities. Finally, integrated cameras were used both for tracking the patient and also in order to provide a video feed, allowing the investigators to superimpose the augmented reality view.

In order to assess this technology, the authors enrolled 20 patients with varying spinal indications for surgery all requiring screw placement (14 Continued on page 5

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18 49

Robotics

Costs currently curbing the rise of robotics in spine surgery

Continued from page 1

during the procedure. The other module is an optical camera that can be moved around the room.” Speaking specifically of the ExelsiusGPS robot (Globus), Prasad said, “One of the very interesting features about this is that it has an active and adaptable end effector. At the moment it is just a cannula for guidance, but you have to let your imagination run and think where all that can go.”

So where can robotics go? Imagining the future of robotic assisted spinal surgery, Patel elaborates to Spinal News International: “The next steps will be robots assisting with the entire surgery, from planning to postoperative care. This would include planning the surgery knowing there will be robotic assistance that allows for more complex procedures to be undertaken, and knowing that the robot can guide us [spine surgeons] to the optimal goal. For example, in planning an osteotomy, the robot could guide us intraoperatively to resecting the right amount of bone at the right angle to get the planned correction. Intraoperatively, it could help us with exposing the spine minimally invasively and precisely in the right spots while monitoring the movement of the patient and the relative movement of the spine. The robot could place cages in just the right locations and then bend the rods to the planned specifications. Even postoperatively, artificial intelligence could be used to monitor patients clinically by assimilating data from all kinds of health and activity monitors, and correlating these data with their X-ray findings to recommend the next steps in recovery. There is a huge opportunity, but it comes at significant cost and effort to get it up and running, and really needs teams of engineers and clinicians working closely together to make it happen.”

These barriers to the use of robots in spine surgery were the focus of several talks at the recent NASS annual meeting, with Andrew Fabiano, associate professor of Neurosurgery and director of Spinal Oncology at Roswell Park Comprehensive Cancer Center, Buffalo, USA, providing advice on how to make a financial case for acquiring new, expensive technology in hospitals, as cost is the biggest barrier to the more widespread use of robots in spinal operating theatres. Fabiano argued that in convincing hospital administrators to buy a robot, the goal was to demonstrate that spine operations are high margin procedures. He emphasised that the number one priority was the quality of the business plan. At its most basic, he explained, the business plan for new technology should prove five things: the device is for high margin cases; there are specific patient volume growth estimates; implementation of the device would establish the hospital’s position as a region leader; the device improves patient outcomes; and finally, that the hospital will be able to retrospectively demonstrate these improvements

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following the purchase.

In addition to the cost, the learning curve of clinicians represents a limitation to the accessibility of surgical robots. Patel explains, “It takes a real champion at an institution to encourage the purchase of a machine, and even greater effort to keep it utilised.”

One such champion is Andrew Cannestra (Baptist Memorial, Jacksonville, USA), head of one of the leading robotic spine surgery centres in the USA. Baptist purchased a Renaissance (Mazor) in 2013, and Cannestra has been an advocate ever since, with the centre purchasing a second robot a few years ago. Conceding there is a learning curve, Cannestra comments, “It is a great tool, but whether you are talking about a hammer or a complex robot, you have to go through the learning curve. That is the surgeon’s job.”

Patel continues: “We almost need a full-time engineer running the robot to get it to work at its real potential. For many clinicians, that learning curve is not worth the effort.

I could foresee the possibility of robots being underutilised or sitting idle after purchase because of this. It happened with early navigation systems—many of them collected dust (even in the ‘clean’ operating rooms) because their use was not “worth the effort” after they were purchased.

But in places where clinicians and technicians worked together, they were successful and improved both efficiency and outcomes of procedures. We need to try to avoid the risk of underutilisation with smart purchases and continual education.”

Corroborating Patel’s argument, Iain Kalfas (Cleveland Clinic, Cleveland, USA) describes how the belief that fluoroscopy-guided navigation is “good enough” may be holding surgeons back from using robotic guided navigation techniques. Indeed, Jang Yoon (Mayo Clinic, Florida, USA) explained the Peter Thiel rule in his NASS talk during a specialist symposium on robotics and navigation in spine surgery: according to venture capitalist, PayPal co-founder and early Facebook investor Peter Thiel in his book Zero to One: Notes on Start-ups, to achieve successful market penetration, a proprietary technology needs to be 10 times better than the current existing one.

Robotics in spinal surgeries are not there yet, but Prasad hypothesises that actually, integrating emerging technologies into clinical practice starts with using robots to perform simple, low risk procedures frequently performed by surgeons, where the gains are less obvious.

Writing in Spine earlier this year, he says, “The evolution of robotics in other surgical domains lends valuable insight into this vision [of robotic assisted spine surgeries]. The early applications of the da Vinci platform (Intuitive Surgical) targeted laparoscopic procedures that were widely accepted and performed. The challenge with

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this was that most surgeons did not feel there was value in bringing an expensive and complex device into the field to perform a procedure they could already perform efficiently and safely. At the same time, the long-term vision for the founders of Intuitive Surgical was to perform complex cardiac procedures using approaches that were as yet impossible. This required a tremendous amount of development and innovation on an engineering front and created the clinical challenge of securing confidence in a procedure that was neither established nor accepted.”

Calling for the same approach in the spinal arena, Prasad concludes, “Ideally, early applications in spine surgery must target applications that are established but not widely performed. This is, of course, a moving target, but there are ample such target applications in spine surgery. The robot must play a role in ‘levelling the playing field’ and enabling traditional surgeons to perform less invasive and/or more effective procedures that are emerging but getting early acceptance, and would be harder to perform without the robot. No doubt, success in establishing a secure early foothold will fuel continued evolution in this exciting space.”

This echoes Patel’s comments regarding learning from soft tissue surgery. Summarising the future direction of robot assisted spinal surgery by looking back at the past quarter of a century of progress, Patel says: “The field of robotics in spine surgery has changed surprisingly little over the last 25 years. When I started in orthopaedics 21 years ago, robotics was attempted in orthopaedic joint replacement surgery but failed due to high cost and increased time of surgery. Robotic technology itself has not advanced dramatically, but what has improved significantly is the integration with navigation and the efficiency of function that no longer means longer surgery.

That has been the first real step forward and hopefully will lead to more and more applicability. On the other hand, with pure soft tissue surgery, robotics has had tremendous success in gynaecology, urology, and general surgery in navigating small spaces and allowing for very fine microsurgery. If we could combine some of their capabilities with spine robots and start to automate them, we would really have something!”

By guiding navigation, robots have the potential to help spine surgeons to be more precise in pedicle screw and device placement. Within the spine surgery discipline, there is mounting literature evidencing the improvements in accuracy and consistency robots provide. Outside of navigation, however, there is still little use for robots in spine operations, though with other areas of surgery showcasing the myriad opportunities in this dynamic space, there is much potential for a greater robotic role in spinal surgery.

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2019

4

Nov

Issue

18 49

Medical ethics

“The last 25 years has seen a technological revolution”: What will the next 25 years bring to spine surgery?

Paul Arnold, a spine surgeon based in Kansas for most of his career, now practising at the University of Illinois, USA, and current chair of the ethics and professionalism committee of the North American Spine Society (NASS), talks to Spinal News International about the ethics of medicine, the danger of the possibility that insurance companies dictate which surgeries can occur through machine learning algorithms, and what the future holds for spinal surgery.

What advice would you give to someone starting their own practice?

When I first started in Kansas, spinal surgery as we know it now was in its infancy, so there was no one really doing what I did. I started the spinal practice from scratch at the University, and built it up to become very large, with a lot of clinical trials and complex patients. If you are just starting out, my advice would be find a niche—there is plenty of room for more spine surgeons.

What would you say are three particular personality traits a spine surgeon should have?

Empathy, relentlessness, and honesty.

Spine surgeons should know where their strengths and limitations lie; if you are honest with yourself, I think you will do well. Not every spine surgeon should do every spine procedure; when people attempt operations they have not been trained to do, that is when most surgeons get into trouble.

You are a neurotrauma consultant for the National Football League. What are the unique challenges that this patient group represent?

The National Football League (NFL) recognised that they had a problem; a lot of famous or well-known football players were having severe dementia problems and a couple committed suicide. So, the NFL decided to be proactive. There is now a head and neck committee for the NFL, run by two neurosurgeons, and a whole

Why do you think it is important to have a society like NASS championing spine surgeons?

I am very grateful to NASS for taking on a lot of the roles that they do on behalf of spinal practitioners; in terms of lobbying in Washington, DC, and advocating for both patients and physicians, I think NASS is really the voice of the spine care practitioner. I am constantly amazed at the breadth of society activity. I did not really appreciate a lot of it until I got onto the Board of Directors, and now I listen to groups talk to our legislators, other groups talking to Medicare about paying for a certain procedure, or groups advocating for certain patients. If we do not do this advocacy work, no one will. It is about advocating for patients and patient care. I think every physician here [at the NASS 2018 annual meeting] went into medicine or surgery to take care of patients; I think this is true at the gut level for every physician, and that is why we do what we do.

What are the key aims of the ethics and professionalism committee?

The committee acts to ensure surgeons are “playing by the ethical rules” of medicine or spine surgery—a lot of it is about transparency. It involves being open about your relationships with industry. Relationships with industry are not inherently bad; the engineers who design these devices may never see the patients treated with them, and you cannot design instruments and hardware for surgeons without surgeon input. Additionally,

The last 25 years has seen a technological revolution. We can take on problems that were completely hopeless before. programme designed for neurotrauma consultants, which has been running for six years. These consultants are on the side-lines at every football game; there is a lot of training involved. It is a great privilege to be associated with the NFL. We provide coverage for both teams during a game, and spend all day at the stadium. I think everyone is taking this problem seriously; the NFL has committed a lot of money to the National Institute of Health (NIH) for research, and they are committed to making sure that players with injuries do not go back before they are ready.

surgeons should be paid for their time and rewarded for their input. However, when surgeons push an agenda, for example by advocating for a device or company they have a financial interest in, then this needs to be disclosed.

NASS has the strictest guidelines for being a board member of any spine society I am involved with. When I joined the board, I had to divest a lot—NASS has really taken the high road in this arena. Transparency, as current NASS president Jeff Wang said [in his keynote address], is critical, and I think that NASS has gone the

extra mile to make sure that the speakers and physicians are compliant with ethical rules.

What is the current status of your company?

I started a company with a mechanical engineering professor at the University of Kansas. Along with an outside group, we designed an interbody cage which acts as a piezoelectric implant—it captures mechanical energy as the patient walks, and translates that into electrical energy, which aids bone growth. We have got some very promising pilot data, and have hired a CEO for the company. We initially received a US$65,000 NIH grant, and recently the company was the recipient of the second phase NIH grant, totalling US$1.5 million—so obviously that is a big deal for the company!

This has been a 10-year project, and one I am very proud of, so we are very excited. We have talked to some potential investors, and hope to take the project to the next level by making some design improvements on the cage, and perhaps enrolling a bigger animal study, before we can potentially take the technology to market.

What is the biggest change you have seen in spinal surgery over your career, and what is the future of spinal surgery?

I do not think there is any doubt that spinal surgery has become far safer, and now tries to solve more problems than when I first finished my fellowship 25 years ago. There were a lot fewer spine surgeons then, and now I think we are tackling bigger problems. Additionally, the last 25 years has seen a technological revolution. When I first started using pedicle screws, there was a big controversy over whether you could use them, including multiple law suits.

Now, there are a multitude of available screws and rods and plates that simply did not exist when I was training.

We can take on problems that were completely hopeless before, and that is a huge change.

I think we need to be careful now that the technology does not outgrow humanity; but I am excited about the next 25 years. I think there is going to be new hardware and drugs and cells and robotics; I think it is possible that surgery will become a video game—or closer to a video game than it is now.

However automated surgery becomes, though, you will still rely on the judgement of the surgeon. To use the analogy of a self-driving car: you can

programme it to get you from A to B, but should you go out in a rainstorm to drive it? Should you go out in the snow? Are the wind conditions safe?

In the same way, the accuracy of the screw placement can be optimised by machines, but the judgement of the physician as to whether or not to operate is going to be hard to machine learn. There is no shame in having a machine implement perfectly placed screws for a patient that needs to have an operation; I am all for that.

Maybe there is going to be an algorithm that will dictate what procedure is needed for which patient.

For example, if a patient has a certain amount of stenosis, and there is a degree of leg and back pain, coupled with certain comorbidities, then an algorithm may be programmed to recommend a particular operation.

However, you will still need some humans somewhere along the line to decide whether that person will have that surgery… and hopefully that will be a physician and not an insurance company.

I think the danger is that these insurance companies will come up with the algorithms, and will establish an arbitrary cut-off. For instance, say an 85-year-old woman has lumbar stenosis, and say she has heart disease and diabetes; the algorithm calculates that there is a 5% risk of complication.

If this were 4.9%, the company might cover it, but at 5% the company will not pay as they deem the risk too high.

We cannot allow that to happen.

My son is in medical school right now, and I advised him not to go into radiology or pathology because I think that will all become machine learned.

I do not think robotics will completely take over medicine, but they are going to cause major disruptions in many medical fields. So watch this space!

Paul Arnold

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Augmented reality

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Augmented reality surgical navigation technology enables high accuracy pedicle screw placement Continued from page 1

deformity cases, three spondylolisthesis and five other clinical indications).

Of the 253 pedicle screws that were placed using the augmented reality navigation system, an overall accuracy of 94% was achieved. On average, a quarter of the procedure time corresponded to the usage of the augmented reality system to navigate the screws, with the median time of screw placement at four minutes.

During the study, no device-related adverse event occurred. Additionally, safety measures showed that the patient radiation dose ranged from 14.1 to 51.4 Gy·cm2, while the total cumulative staff occupational dose ranged from 0 to 3.2µSv. According to Burström, this minimal staff dose owes to the fact that all of the personnel were behind shielding when X-ray was used.

Concluding the findings, Burström said: “This was the first ever clinical study on an augmented reality surgical system, which seems to offer a high accuracy for pedicle screw placement. Of course, further studies are needed with comparison to other techniques.”

Augmented reality may enable a new era of wearable devices in spine

The interest surrounding such techniques seems to be impossible to avoid, with the rise of robotics and navigation made clear, if only considering the number of talks presented on the topic at the North American Spine Society (NASS) annual meeting (24–29 September, Los Angeles, USA).

Jang Yoon from the University of Miami Miller School of Medicine (Miami, USA), spoke about his journey into augmented reality through his interest in wearable computing devices and their application

to spine navigation. He noted, with regards to the current technology used in spine navigation, that it remains screen-based. Yoon described a drawback of this technology: “If you’re placing a pedicle screw, you [spine surgeons] get the perfect starting point anatomically, but you take your eyes off to look at the screen and the instrument slips.”

Therefore, Yoon and colleagues decided to create a device that was able to present the same information— augmented through Google Glass technology—that can be subsequently broadcasted to a phone or tablet.

Additionally, the Google Glass enables voice command; responding the command of the surgeon, allowing the surgeon to remain focussed.

According to Yoon, when comparing the amount of time it takes to place a screw, it was 15% quicker when using a wearable device as opposed to open navigation—however, he alluded to a notable amount of bias in this finding.

Furthermore, Yoon pointed to a particular limitation of the glasses, stating that the screen is very small and transparent, and for this reason, will require further development. However, addressing the NASS audience with regards to what the future holds for this technology, Yoon said: “There is a lot of interest

Augmented reality will disrupt the [spinal] surgical landscape.

Augmented reality surgical navigation

in applying holograms and actually overlaying the navigation information onto the patient themselves.

“This is just a glimpse of what can be possible in the future, yet for neurosurgery and spine surgery, it requires submillimetre accuracy,” Yoon continued, and explained that it first starts with making “anatomically super-accurate maps” by implementing a machine learning algorithm to create holograms based on 2D MRIs. In relation to where we are now, Yoon concluded that this augmented technology may play a role in the nextgeneration of navigation, with probably improvements in the gaming industry driving its evolution. “Eventually, it will cross over into the surgical field and disrupt this landscape,” he said.

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Nov

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18 49

Healthcare economics

Is all ignorance bliss? Expenses for implants in surgery decrease when prices are known, study shows Costs were found to decrease for implants in surgery when prices were known, concludes a study presented by Andrew Glennie from Dalhousie University, Halifax, Canada, at the Eurospine 2018 annual meeting (19–21 September, Barcelona, Spain).

were no significant differences in surgeon costs or in health-related quality-of-life outcomes for patients.

“SUFFICE TO SAY there is quite a bit of opportunity for cost savings, as there is quite a dramatic difference in the costs of implants depending on what you choose to use in these CDF’s [cervical discectomy and fusion] versus what you choose to use in single level lumbar spine fusion,” said Glennie.

Given the variations in costs, Glennie and colleagues aimed to determine whether surgeons change their choice of implants or equipment once they are aware

Glennie concluded his presentation by saying that although expenses decrease for implants in surgery when prices were known, this appears to have little or no effect on overall costs of care. However, he maintained that length of stay and operating room time appear to have equal or greater effects on global costs.

He further alluded to a couple of caveats in the study. For example, in addition to being limited by the five-month time period on each side, there were no long-term data available for follow-up beyond three months. Furthermore, generalisability comes into question, as the study was only carried out at a single site.

During the audience discussion, Glennie was questioned on whether he would expect the results to be different with longer follow-up data. He responded by saying, “I absolutely do, yes… [however] there are rigid post-operative protocols that drive costs up, and that is where you need to focus your attention… not necessarily on costs in the operating room”.

Moving forward with the current findings, Glennie notes that cost containment strategies focusing on savings with instrumental costs are likely very short sighted. Therefore, future efforts to encourage efficient cost savings should focus on practice variability for similar conditions, and better long-term collection of cost data—rather than limiting the use of certain implants.

he reports, include rapid technological advancements and a single payer healthcare system.

The study set out to determine the costs of all implants used by a spine surgical service at a large tertiary care centre. Three procedures; anterior cervical discectomy and fusion (ACDF), posterior cervical fusion and single level lumbar interbody fusions, were included. To ensure quality-of-life outcomes were equal in patients, the investigators

Surgeons may remain somewhat naïve to the costs of particular devices or surgical equipment, including the impact on overall costs of care. of the specific costs.

Surgeons were initially blinded for five months— in which they were unaware of costs—followed by another five months where detailed cost information was known, allowing the investigators to gain an insight into how this information would affect physician behaviour.

Glennie acknowledges that particularly in Canada, surgeons may remain somewhat naïve to the costs of particular devices or surgical equipment, including the impact on overall costs of care. Reasons for this,

collected quality-of-life scores three months after the procedure. Statistical analysis was undertaken with STATA software.

Costs were found to have decreased by CA$478 for instrumentation once actual prices were known— but this result was not statistically significant (p=0.069). Interestingly, only ACDF procedures demonstrated statistically significant cost savings of CA$754 (p=0.009). Procedural costs were also less (CA$297; p=0.194) as well as the total overall costs of admission (C$401; p=0.228). Furthermore, there

No effect on overall healthcare costs

International interest in physician wellness escalates

Speaking anonymously to Spinal News International, a career and life coach for physicians said that the most effective way to address the issue of physician burnout, in his experience, is “experimental learning during the course of a three- to six-hour workshop on the topic, where physicians can dig deep into their own life experience and come up with specific individual action steps and timelines to address their own unique stressors and circumstances.” This is what Todd J Albert (Hospital for Special Surgery, New York, USA) did at the Scoliosis Research Society (SRS) annual meeting (10–13 October, Bologna, Italy), where he organised a pre-course half-day meeting focusing on mental health.

D

edicating time to physician well-being has been one of the hallmarks of Albert’s SRS presidency this year; in July, he gave a keynote address at the International Meeting on Advanced Spine Techniques (IMAST; 11–14 July, Los Angeles, USA), where he advocated for the adoption of certain individual- and institution-level interventions to help lessen the strain on surgeons’ mental health.

However, at SRS, the focus was broader, encompassing many different surgeons’ experiences of both excellent and poor mental health, and the ambition greater, with multiple suggestions of tools and lifestyles aimed at self-awareness and improvement. Increasingly over the last few years, mental health has been recognised as a significant concern for physicians. Research by Tait Shanafelt (Mayo clinic; Stanford Medicine, Stanford, USA) involving surveying 7,000 physicians found that there are 400 physician suicides a year in the USA, twice the suicide rate of the general American population. Death by suicide is the second leading cause of death among medical residents. Fifty-four per cent of doctors say they are burned out; 88% acknowledge

they are moderately to severely stressed, and 59% of doctors say they would not recommend a career in medicine to their children. The study investigators also found that, between 2011 and 2014, there was an increase in the percentage of physicians reporting burnout, and a decrease in the number of surgeons who believed they experienced a good work-life balance. North American orthopaedic surgeons rate in the lowest third of all care workers for work-life satisfaction, and the highest for rates of burnout.

This is the backdrop to the premeeting course put together by the SRS, spearheaded by Albert. The course was separated into two sessions: physician preservation and physician growth.

Emphasising the importance of discussing physician wellness with an international group of delegates, Albert told Spinal News International: “Physician well-being and problems with burnout are an increasingly recognised problem in our healthcare community. It cuts across national and international lines as well as across specialties within healthcare. Therefore, it is incredibly important to focus on this topic within our conference, and even more importantly at an international conference.

“The delegates leave the meeting with a sense of purpose and begin their wellness journey, which starts with recognition and the ability to identify those who may have a problem with their emotional well-being in a non-punitive fashion. Further, we hope that they will learn tools to begin to manage these issues and embark on improved wellness behaviours. Other conferences are increasingly taking this mantle and identifying and teaching about wellness and tools to enhance physician well-being and decrease burnout. Certainly, we are doing this at the Hospital for Special Surgery (New York, USA) as well.”

Attending Faculty member at SRS Teresa Bas (La Fe University and Polytechnic Hospital, Valencia, Spain) told Spinal News International that, in her experience, there is not a strong focus in Spain on physician well-being. She comments: “My biggest take-away from the pre-course meeting is the need to have a coach—someone to help you improve your practice. This topic is specifically significant for physicians practicing in Spain because no one has worried about this issue, and surgeons are viewed as ‘lone rangers’. People believe that having a coach means you are lazy, which is

nonsense. I think we need to change this mind set in Spain; we need an awareness and a recognition of the importance of both physical and psychological health.

“I think talking about surgeons’ health is hugely important. The well-being of the surgeon is transmitted to the patient through the performance and care the surgeon is able to provide; it is important for physicians to take care of themselves and to take the necessary measures to work in the healthiest way possible.

“The course also stressed the importance of mindfulness to retrain your brain to more easily relax from stressful situations, doing a sport to improve surgical dexterity and to eliminate toxic energy, and eliminating toxic friendships.”

Several SRS attendees who will be hosting international conferences in 2019 expressed interest in including a similar symposium at their event. Samir Dalvie (Hinduja Healthcare Surgical, Khar, India) stressed to Spinal News International that the pre-course meeting was a congress highlight, and that he now hoped to have a focus on physician wellness at a future AOSpine meeting in India. The conversation about physician burnout has transformed into international action.

Nov

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Predatory publishing

7

Combating the rise in predatory publishing Christopher M Bono Comment & Analysis “Dear Distinguished Professor, we invite you to submit...” Christopher M Bono warns of the rise in predatory publishing, drawing on his own experiences of falling for a well-worded scam email. As editorin-chief of the North American Spine Society’s flagship publication The Spine Journal, Bono speaks of his regret at how this action helped prop up the network of “fake” journals, and advocates for the #peersforpeers campaign, a movement emphasising the critical role that peer review plays in medical publishing.

O

n a daily basis, most of us receive emails that often begin with the something like the title of this piece. The email author first compliments you for being so accomplished in your field. Then, you are invited to submit an article to their “highly prestigious” journal, the title of which you have never heard. Most times, the deadline is fast approaching, a few weeks or even days away. Should you not respond to the invitation, a slightly intimidating followup note is sent, beginning with something like the following: “We have not heard from you…” The journals purport to be highly indexed by metrics other than the traditional impact factor. Often times, the journal title is so esoteric, dealing with fields that have nothing to do with spine care, that you push the delete button nearly automatically upon receipt of the email.

However, others are more thoughtfully

crafted, sounding like well-known spine journals. Sometimes, they are very seductive and alluring. This is the modus operandi of predatory publishing.

You may think that no one falls for these solicitations. But, like other types of spam emails—and phone scams— they continue to exist because they sometimes work. Indeed, quite a few years ago before I was aware of such predators, frustrated with a paper that I had difficulty getting published, I fell for the hook. I submitted my article, had it accepted promptly with no revisions recommended, and was asked for the very hefty (about US$2000) fee to finalise publication. I was a victim of predatory publishing, and in this small article, I am confessing to the spine world at large.

As the editor-in-chief of a “real” journal (The Spine Journal), I regret

terribly having fed the network of “fake” journals. However, it highlights the vigilance we all should have. Perhaps this is the movement that needs to be started—#peersforpeers—with true peer review being the critical distinguishing feature between respected journals and those that subscribe to pay-to-publishing.

Remember, the true goal of medical publishing is to enhance the knowledge base in order to expand scientific understanding of patient care.

Unfortunately, publishing, even in legitimate journals, can be used for ancillary reasons. Academic promotions are often linked one’s number of publications. This link cannot be underestimated, characterised by the phrase “publish or perish.” More nefariously, publications can be used to promote a centre, a surgeon, or a technique. Even for studies published in a predatory journal that will never be cited, an individual can use reprints of a paper to legitimise a technique or product.

“Look here—it is in print.” This is about as reliable as saying, “I read it on the internet. It must be true.”

As a final point, I want to highly a “victim by association” of predatory publishing—the concept of open access.

To my knowledge, predatory journals exclusively use online platforms that facilitate open access (if you can find the website). This can tarnish the open access options at legitimate journals. For instance, Ghogawala et al’s landmark article published in the New England Journal of Medicine in 2016 is an open access article. In this one example, I do not think anyone would argue that Ghogawala’s article is any less of a

gem because it is open access. Yet, open access and predatory journals are sometimes terms used interchangeably.

They are assuredly not.

As a final warning, beware of predatory journals. Like telephone scams, even smart, sophisticated people can fall victim on occasion. While it is tempting to proclaim, “somebody needs to do something about this,” or “these journals should be called out,” this is an ever expanding field. It is an international phenomenon that does not lie under the jurisdiction of any one governing body. In the end, the responsibility ultimately comes down to the submitting authors. If there are no users, then this “product” will disappear, perhaps in coming years.

For now, awareness the best defense.

Illustratively, while writing this piece on a Wednesday morning, I received an invitation to submit an article to a computer science and engineering journal. The submissions are to be sent to two personal email accounts. The deadline for submission is in five days.

Oh, and by the way, there is a meeting at which I can present my work in Hong Kong next month. I owe this invitation based on my “great expertise in this field.” I am neither a computer scientist or an engineer. I think I’ll pass.

Christopher M Bono is a professor of Orthopaedic Surgery at Harvard Medical School, Boston, USA, and is the executive vice chair of the Department of Orthopaedic Surgery there. Bono is also director of the Orthopaedic Spine Surgery Fellowship Programme, and editor-in-chief of The Spine Journal.

Surgical intervention found to significantly improve frailty in adult cervical deformity A recent study has reported significant improvements in patients’ frailty status at one-year after surgery, as shown by the cervical deformity frailty index (CD-FI). The data, including a discussion about the efficacy of the index tool itself, were presented by Peter G Passias, NYU Langone Health, New York, USA, at the North American Spine Society annual meeting (NASS; 26–29 September, Los Angeles, USA).

PASSIAS ACKNOWLEDGED THAT cervical deformity can be a severely debilitating condition, while it also poses a significant challenge for surgeons with regards to its pathology. Furthermore, the deformity encompasses a wide range of aetiologies, including spondylosis, inflammatory arthropathy, trauma, and infection, as well as congenital and neuromuscular pathologies.

Passias described the concept of frailty; a term derived from the geriatric literature. However, he noted that instead of acknowledging a patient’s chronological age, it attempts to encompass the pathological age, i.e. how deconditioned or frail a patient is.

The cervical deformity frailty index (CD-FI) was recently devised by Miller and colleagues, which correlated increased patient frailty with longer hospital stays, higher complication rates and increased risk of non-home discharge. However, Peters suggested that the limitations of the CD-FI should not be overlooked.

The index requires 40 health variables (from a patients demographic and surgical information) to calculate a score, yet it is unknown which of the variables have the

greatest potential for change or are the primary drivers of post-operative change in frailty.

Therefore, Passias and colleagues aimed to investigate the component variables of the CD-FI in order to determine the impact of corrective surgery on the index, while also identifying which component variables of CD-FI are modifiable, as opposed to those that are non-modifiable.

A retrospective review of a prospective multicentre cervical deformity database, at multiple sites through the USA, was carried out. The inclusion criteria were radiographic; patients had to have a certain amount of kyphosis, for example a C2–7 sagittal or coronal Cobb angle of ≥10°, a C2–7 sagittal vertical axis ≥4cm or a chin-brow vertical angle of≥25°. Additionally, all patients were 18 years or older, and their CD-FI was examined at baseline and after one year.

Passias noted that 40 variables are used to calculate the frailty index, including past medical history questions (such as a history of congestive heart failure, stroke, or high blood pressure), as well as and healthrelated quality of life questions (HRQL). The latter are

taken from various forms, such as: the Neck Disability Index (NDI), the modified Japanese Orthopaedic Association scale (mJOA), the Quality of Life in Swallowing Disorders questionnaire (SWAL-QOL) and other similar instruments.

Frailty as a measure itself was assessed using the cervical deformity frailty index (CD-FI), scored on a scale between zero and one. Patients were subsequently stratified by CD-FI scores, which resulted in three groups dependent on the patient’s level of frailty. A score of below 0.3 was defined as “not frail”, with patients falling between 0.3–0.5 classified as “frail” and those above 0.5 “severely frail”. In total, the patient population included 138 cervical deformity patients (62% female; mean age: 61 years; mean BMI: 29.3).

The Charlson Comorbidity Index indicated an average score of 0.92 for the patient cohort.

Regarding the change in frailty following the surgical intervention and CD-FI variables, Passias reported that patients significantly improved, shown by the change in the baseline frailty scores from 0.44 to 0.27 after oneContinued on page 10

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Advertorial

A neurosurgeon’s experience with PEEK-OPTIMATM HA Enhanced devices Jill Wright Donaldson, MD, is a neurosurgeon at Community Hospital North (Indianapolis, IN, USA), specialising in the surgical management of complex spine disorders, neoplasms of the brain and spine, and peripheral nerve entrapment. Dr Donaldson is a member of many professional organisations, including the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS). Here, she discusses her experiences using both PEEK and additive Titanium implants in the operating theatre, using case examples from her clinical practice, and describes why ultimately, she chose to implant the EVOS-HA device (Cutting Edge Spine) made from PEEK-OPTIMA HA Enhanced (Invibio Biomaterial SolutionsTM) during spine surgery.

PEEK-OPTIMA HA Enhanced interbody fusion devices preferred to 3D printed Titanium implants Dr Donaldson initially used 3D printed devices in her practice. Explaining this choice, Dr Donaldson expands on her clinical experiences with these implants: “I was looking for something that would encourage bone on-lay. Traditional PEEK is more hydrophobic and acts much more like a spacer, whereas I was looking for something that would take a more active part in the fusion. I have used several 3D printed devices, including the 4Web Medical and Stryker offerings. Those are two that I still use periodically, so I have not abandoned them altogether. However, I do worry about the endplates in older patients, and the lack of elasticity in a titanium device—it might be a more suitable option for a younger patient.”

In fact, Dr Donaldson says “I prefer to use HA enhanced PEEK for all patients”, citing bone quality in geriatric patients as a cause for concern and a primary driver in the decision making process.

Another factor Dr Donaldson takes into consideration is imaging. She expands, “My experiences with 3D printed devices were overall positive. I did not have any significant re-operative cases or any significant problems. There were a few incidences where I thought the device subsided into the endplates, but clinically the patients still did well. The decision to move away from 3D printed devices was not really a clinical one as much as a radiographic one: I did not like the X-ray as much with the titanium implants.”

“This is because the titanium implants are not radiolucent, unlike PEEK. I typically follow all of my patients for a year; as long as they are doing well at the end of that year and there have been no significant changes in their implants, I assume they are fused. I will only do a CT if they are having symptoms.

One of the big perks of PEEK, whether it is HA enhanced or the traditional material, is that it is radiolucent, allowing you to monitor the implant over time and follow the fusion better than with an X-ray.”

The move towards HA Enhanced PEEK implants has been a “game changer”

Hydroxyapatite enhanced PEEK has been revolutionary. Speaking of her personal clinical experiences, Dr Donaldson explains, “Once the HA device changed the properties of PEEK so that the material is more of an

active player in fusion, that was a real game changer for me.” In addition to the superior imaging properties of PEEK, Dr Donaldson finds that her patients appear to be recovering from the fusion quicker when the interbody fusion device used was a PEEKOPTIMA HA Enhanced cage compared to 3D printed Titanium alternatives.

She reports, “My observation is that the patients seem to be getting better faster, and I think some of that is just due to the fact that PEEK has a different elasticity to it, and it is not as rigid. At earlier office visits, clinically, my patients look healthier; at six weeks post-operatively they look like a three-month post-operative 3D printed Titanium patient, and they really seem to be doing much better much more rapidly, they seem to be ahead of the game. I give them all strict activity restrictions for three months, but patients at six weeks walk in and for most of them you cannot tell they have had surgery. They truly seem to be healing faster.”

Even right after surgery, Dr Donaldson reports a speedier recovery in patients fused with the EVOS-HA devices. In the cases presented here, the patients were all discharged from the hospital two days post-operatively, which is typical of this type of procedure. However, Dr Donaldson adds: “I have had several patients recently that probably could have gone home the next day, and a couple that have actually left the day after surgery. They truly look great and there is no reason to keep them. It is a clinical decision, not an insurance one; the HA enhanced PEEK really makes an impact.”

Furthermore, Dr Donaldson also reports her patients fused with an EVOS-HA device are becoming opioid independent sooner than her other fusion patients. “Some of them take narcotics for a week and they are done, and they really seem to have a lesser need for pain medication for the most part much sooner,” she told Spinal News International. In the midst of the opioid epidemic, Dr Donaldson stresses the importance of reducing postoperative narcotic consumption: “It is critical.

The faster you can get people off pain medication, the more active they are, and the better they do. There is so much concern with addiction and narcotics, now more than ever, that any time you can get somebody off pain medication in a quick fashion, it makes an enormous difference.”

Successful interbody fusion in a geriatric patient using a PEEK-OPTIMA HA Enhanced cage

Pre-operative MRI scan

Case description

A 78-year-old female patient presented with progressively severe back and bilateral leg pain, radiating into both hamstrings. She had failed extensive conservative treatment, including physical therapy, chiropractic care, and lumbar epidural steroid injections. The patient did not smoke. A physical exam revealed no motor or sensory deficits. She flexed forward significantly when walking.

Surgical intervention

We treated the patient via decompression at the affected levels, L3–L4, and reduction with a mini-open posterior lumbar interbody fusion. The interbody fusion involved the placement of a bilateral EVOS HA cage (Cutting Edge Spine) in combination with iliac crest autograft from a transfascial approach, local autograft, and bilateral pedicle screws.

Outcome

The surgery was successful. The patient was discharged from hospital and went home two days after surgery, and one week post-operation was off all narcotic pain medication. She experienced no significant back or leg pain at either two weeks or 12-months’ follow-up.

Top: Six-month post-operative X-ray Bottom: Six-week post-operative X-ray

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Single-level lumbar fusion in a middle-age female using 3D printed Titanium cages and autograft bone Case description

A 52-year-old female patient, a non-smoker, presented with progressively severe lower back pain and bilateral leg pain from the buttocks to the hamstrings. Like the patient detailed in the first case report (see page 8), this individual had failed conservative treatment, including physical therapy and lumbar epidural steroid injections. A physical exam revealed mild 4+/5 left dorsiflexion and 4+/5 bilateral extensor hallicus longus weakness, as well as hypesthesia in the left foot dorsum.

Pre-operative MRI scan

Pre-operative X-ray

Six-month post-operative X-ray

Six-month post-operative X-ray

Pre-operative MRI scan

Pre-operative X-ray

Six-month post-operative X-ray

Six-month post-operative X-ray

Surgical intervention

We performed a mini-open posterior lumbar interbody fusion at L5–S1 with Gill-type laminectomy, using 3D printed Titanium bilateral Truss cages (4WEB Medical), iliac crest autograft from transfascial approach, local autograft, and bilateral pedicle screws.

Outcome

The patient was discharged home on the third day following surgery, so a day later than the patient described in the first case report fused with the PEEK-OPTIMA HA Enhanced device. There was no leg pain and only mild back pain at six weeks and 12 months. Narcotic use was also more extended in this patient; she was off narcotic pain medications after six weeks, compared to just one week in the patients fused using a PEEK-OPTIMA HA Enhanced device.

Single-level lumbar fusion in an elderly male using the EVOS-HA device with autograft bone Case description

A 70-year-old male, who is a non-smoker, presented with severe lower back pain and bilateral lower extremity pain for two years, with pain from his hips to anterior thigh. He was experiencing chronic left foot numbness and mild weakness from prior left L4–5 discectomy. A physical exam revealed 4+/5 left dorsiflexion weakness, and left foot dorsum hypesthesia with antalgic gait.

Surgical intervention

We performed a mini-open posterior lumbar interbody fusion at L3–4, using bilateral EVOS HA cages (Cutting Edge Spine), iliac crest autograft from transfascial approach, local autograft, and bilateral pedicle screws. This was the same procedure and the same instrumentation as detailed in the first case report.

Outcome

The patient was discharged home on the second day after surgery, and was off narcotic pain medications at seven days’ post-operation. He experienced no leg pain or back pain at six weeks or at six months, but had no change in chronic left foot numbness and weakness.

INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

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Surgical intervention found to significantly improve frailty in adult cervical deformity Continued from page 7

year following the surgical intervention (p<0.001); a finding which Passias stressed was very important.

In terms of improvements in radiographic and frailty component variables at one year, significant improvements—shown through statistically significant correlations extracted through the questionnaire— were observed in the following measurements: the ability to read

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E-learning

(p=0.045) and whether or not patients felt exhausted (shown through SWAL 9E; p<0.001).

Regarding the linear regression analysis, Passias and colleagues found a significant improvement in patients’ EQD5 VAS (EuroQoL, 5 Dimension Visual Analogue Scale) score and also in their anxiety. The authors noted that improvements in feeling exhausted, as well as achieving the lowest Ames

deformity classification (indicating successful surgery) were the greatest predictors of post-operative frailty change.

Summarising the results, Passias concluded that the changes in the CDFI at one-year post-surgery indicated that average frailty decreased from 0.44 (a “severely frail” status) to 0.25 (“frail” status). Additionally, out of the 40 variables that were included in the index, half of them (20/40) improved at

one year; with a third (13/40) improving significantly. The majority of the drivers of frailty were related to the outcome measures, such as: reading without pain, feeling exhausted, and the ability to drive—which all showed the greatest correlation with change in frailty.

Therefore, he stated that improvements in a patient’s ability to not feel exhausted or weak, as well as overall balance and sagittal alignment, are all highly correlated with improved postoperative frailty status.

Passias said that it became clear that surgery has the ability to improve all of these measures, as it resulted in patients becoming more active, while enjoying a better quality of life.

Eurospine audience sceptical of digital learning’s potential in spinal surgery training As emerging and existing technologies continue to shape the way we communicate and spread knowledge, the potentials of digital learning is given increasing consideration. At the recent Eurospine 2018 annual meeting (19–21 September, Barcelona, Spain), the importance of remote or internet-based learning via a digital platform, also known as e-learning, was debated at length.

An audience poll following the debate showed 89% of Eurospine delegates agreed that the format “may have a role in spinal surgery education”, though only 18% believed that “e-learning is definitely the future of spinal surgery education”.

A

rguing for the benefits of e-learning, Bernhard Meyer from the Technical University of Munich, Germany, stated that for him, basic e-learning involves the transfer of face-to-face activities to an online platform.

Meyer pointed to the versatility of e-learning, with precourse learning, referencing and mutual classrooms already having been implemented in other disciplines. Of the extent the field is likely to change due to e-learning, he said: “Not so much for now—except for one important thing: education and training will become more homogenous. […] If we give access that is affordable to people for online learning, education and training will inevitably become what I think it should be—more regular.” He further noted that there should not be a difference in treatment or education depending on where in Europe one trains, and that digital learning can help to standardise education and training.

“It is inevitable; it is in-line with the general development of society […] the only question is how to transform it,” Meyer stated, arguing that e-learning opens opportunities for developing countries: “The number one pre-requisite for this is that it must be affordable, otherwise it becomes an elite thing.”

Despite these benefits however, Meyer acknowledged certain shortcomings of e-learning. He used the example of case-based discussions to illustrate that the lack of direct contact between teacher and trainee could become an issue: “People open up and express their opinion on a particular case […] while talking on a social level about it sometimes changes the way you view your opinion and work, [which is] an important aspect, and lacking within e-learning.”

Although younger specialists and trainees may be more flexible and accepting of digital learning modalities, the older demographic of surgeons (including the Eurospine Education Committee) are more likely to question its efficacy, Meyer

How effective is e-learning in order to train a student to tell a patient that they have cancer?

suggested. In light of this, he proposed the use of a “hybrid model”, where lectures are presented online first, and face-toface sessions occur afterwards. Throughout, progress would be dependent on acceptance of this methodology, allowing for a “step-wise transition”.

Meyer suggested that if acceptance is high, a live case discussion could occur through live media streams, for example. However, he reiterated the issue with skills training—approximating that skills training through

unable to be tailored according to such needs, feedback, or specific interests of the student. “Learning is not just transmitting knowledge,” he noted, “and it is important to have the trainers know the weak and strong spots of their students.” From a patient perspective, Pereira suggested there may be a lack of trust in a surgeon with only an “e-learning certificate”.

Directly comparing a hands-on approach to eLearning, Pereira maintained, “Importantly, we are missing interaction and team work. […] Students lack connection with the experts, but also the input from trainers, that sometimes change the learning experience.” Concluding his argument, Pereira said, “We are missing networking and missing fun.”

During the audience discussion, Meyer acknowledged Pereria’s argument, saying, “society always needs time to adapt; if you force something on a society, it will react adversely.” However, he rebutted Pereria’s argument that

E-learning is inevitable; it is in-line with the general development of society. The only question is how to transform it. eLearning may occur five to six years down the line.

Irrespective of this, he concluded that the future of e-learning is in-line with the development of our current society, and is certainly feasible.

Taking into account Meyers’ argument for the use of e-learning in spinal surgery, counter-argument debater Paulo Pereira (Centro Hospitalar São João, Porto, Portugal) began by implying that learning over the internet produces an oversimplified and reductive means in which to understand the complex nature of the task at hand. He stated that although the advantages of e-learning should be taken into consideration, its potential application to spinal surgery is another matter.

In agreement with Meyer, Pereira acknowledged that e-learning is not a novel concept, as over 100 presentations on e-learning took place during the 2005 meeting of the International Association for Medical Education. However, Pereira maintained that although the method may work in order to teach neuroanatomy, it may only be moderately effective for teaching examination of the cranial nerve. More importantly, he asked the audience, “how effective is it in order to train a student to tell a patient that they have cancer?”

Pereira acknowledged that in terms of face-to-face learning, it is important to know exactly what can be replaced. Through e-learning, he argued, there is no possibility for immediate feedback to particular questions a trainee may have. Additionally, the course may be

patients would not want to be operated on by a surgeon that had received digital surgical skills training, stating that surgical skills training in the operation room is still needed, regardless of digital learning components; however, being better prepared by an interactive feed of a successful surgery is “better than fiddling around in a corpse”. Yet Pereria maintained that the future should focus on live interaction, using e-learning as a facilitative instruction tool—albeit a powerful one.

In complete agreement, Meyer and Pereria both stressed that mentorship and bonds with peers are important benefits of face-to-face learning which are unlikely to be replaced in a purely digital environment. “Even in 10 years from now,” Meyer said, “once in a while you will need to see someone face-to-face.”

Once the debate had finished, Acaroglu presented three statements to the audience, of whom were asked to vote whether they were in agreement. Following the debate, an audience poll revealed 89% to be in agreement with the statement: “e-learning may have a role in spinal surgery education”, while only 18% of the audience agreed that “e-learning is definitely the future of spinal surgery education”. To the latter, 44% answered “maybe”, and 38% disagreed.

In light of these figures, Meyer agreed that some scepticism of e-learning as the future of spine surgery is healthy, concluding that “nobody can look to the future, so [we] need to be careful in any transition [we] try to propagate.”

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Spinal muscular atrophy

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New data show Spinraza beneficial in the treatment of spinal muscular atrophy in infants Rates of survival are higher, and respiratory intervention rates are lower, in 25 infants with presymptomatic 5q spinal muscular atrophy (SMA) treated with Spinraza (nusinersen). Biogen announced these new interim results from their NURTURE trial; this is an ongoing open-label, single-arm efficacy and safety phase 2 study of Spinraza in 25 presymptomatic infants with SMA. The data were presented in a late-breaking session at the 23rd Annual Congress of the World Muscle Society (WMS; 2–6 October, Mendoza, Argentina).

THE INTERIM ANALYSIS evaluated survival and respiratory intervention rates in 25 infants who were genetically diagnosed with presymptomatic SMA and also began treatment in the presymptomatic stage of the disease.

As of May 2018, all patients in the study were alive and none required tracheostomy or permanent ventilation.

Additionally, 22 of the 25 participants were able to walk with assistance, 17 participants were able to walk independently according to the motor milestone standard of the World Health Organization, and all 25 were able to sit without support.

“The NURTURE study results demonstrate that early diagnosis and treatment with nusinersen has the potential to change the course of SMA,” says Wildon Farwell, senior medical director, clinical development at Biogen. “This is the longest available span of data on infants with SMA who began treatment in a presymptomatic period and indicates that children treated early with nusinersen can achieve motor milestones they would likely not attain without treatment.”

The motor skills of study participants

were also evaluated using the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND), an assessment which considers 16 different types of movement to create an overall score between zero and 64. The mean CHOP INTEND scores were 62.6 (min, max: 58, 64) for study participants with three copies of the SMN2 gene and 61 (46, 64) for those with two copies of the gene.

All NURTURE study participants were 14 months or older at the time of the analysis (median: 26 months; range: 14–34.3 months). Participants included infants with two copies of the SMN2 gene (15 of the 25 patients) who are likely to develop an often fatal, early-onset form of SMA known as Type 1, and infants with three copies of the SMN2 gene (the remaining 10 of the 25 infants) who typically develop SMA Type 2 or 3.

People living with SMA Types 2 and 3 may never be able to walk or will lose that ability over time. No specific safety concerns were identified.

Additional research presented at WMS looked into possible biomarkers for SMA. The investigators compared levels

of phosphorylated neurofilament heavy the disease progression of SMA. chain (pNF-H) in plasma in more than 300 “We continue to develop tools to inform patients from nusinersen clinical trials, our clinical research and are encouraged including those in the NURTURE study, by the potential of neurofilament as a and a control group of infants without biomarker for SMA, how it could further SMA. The data expand the scientific understanding of this demonstrated rare disease and, more importantly, its that treatment potential impact on those living with with nusinersen SMA,” concludes Farwell. is associated with Recently, the UK’s National a rapid decline Institute for Health and from baseline Care Excellence (NICE) followed by published its Appraisal stabilisation of Consultation Document pNF-H in plasma (ACD) outlining a ‘minded at levels close no’ for the routine funding to those of healthy of Spinraza (nusinersen) controls.

Spinraza for the treatment of SMA in For those patients with England, Wales and Northern Ireland, two SMN2 copies, the triggering vice president and managing mean pNF-H concentration was 1,447pg/ director of Biogen UK and Ireland Terry mL at 788 days. Individuals with three O’Regan to urge NICE and NHS England SMN2 copies had a pNF-H concentration to continue to work with the company on of 315.4 at 540 days. In contrast, the agreeing the terms of a managed access median plasma pNF-H in children without agreement (MAA), “so that patients in SMA aged less than one year is 1,510 England, Wales and Northern Ireland pg/mL. The results are part of Biogen’s can share equality in access compared ongoing work to identify and validate to other countries across Europe and biomarkers that could provide insight on the world.”

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Interview

Profile

Donna Ohnmeiss

A self-described “long-shot” and in the first generation of her family to attend university, Donna Ohnmeiss speaks to Spinal News International about why she chose to put her degree in mathematics to use in clinical research, and how her work on healthcare outcomes ultimately led to her position on the Board of Directors of the North American Spine Society.

She warns readers of the rise in predatory publishing, explaining how it is threatening the peer-review process, and explains how she believes improvements in diagnostics is the most exciting development in today’s spinal space.

When did you know you wanted to go into research, and what drew you to spine research specifically?

Clinical research was not something I had ever thought of entering into as a career. Coming out of graduate school with my Master’s in Mathematics and some computer programming background, the opportunity arose. I have always enjoyed working with numbers, and clinical outcome studies seemed to be a good fit. It was also great to think that I could use my love of numbers to impact healthcare.

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

My first research mentor was Heikki Vanharanta from Finland. He taught me very much about how to think about designing research studies and the data generated from them. I will also always be very grateful to Jan Ekholm at the Karolinska Institute in Stockholm, Sweden, for allowing me to study under him for my doctorate.

What is your proudest career achievement to date?

It is difficult to say. Getting my doctoral degree was wonderful, particularly considering I was somewhat of a long-shot growing up in a small town and being in the first generation of my family to go to college. It was also an achievement for me to get comfortable presenting at conferences. It can be intimidating to take the podium at a large meeting. It has been great to be involved with professional societies. This year I was the co-chair of the NASS annual meeting and also served on their Board of Directors. It is a real honour to work with such a committed group of professionals.

How has the field changed since you started your career?

I have been in it so long there have been many changes.

Much of the data collection has gone to electronic capture, the development of registries, and now it is much easier to access literature online. But the increasing use of technology has also created some problems related to just “slicing and dicing” large databases multiple times to generate presentations and publications rather than taking more time and effort to generate something potentially more useful and meaningful. Also, online journal access has given rise to the problem of predatory journals, which threatens the credibility and quality of the peer-review process and publishing.

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

There is a lot of excitement about stem cells and minimally invasive surgery. However, I think what is likely more important for spine is in the basic areas of diagnosis and getting better at matching specific

treatments with specific patients. This involves imaging, psychology, biomechanics, and solid clinical diagnostic skills, as well as continually improving technologies and collecting data to generate evidence for specific interventions in defined patient subsets.

What is the biggest challenge in spinal research at the moment?

One of the greatest challenges for spine research remains adequate funding. While back pain is a major cost to healthcare, there is very little funding dedicated in this area. Back pain is a very complex, multifactorial problem. Much work is needed to optimise the cost-effectiveness of care and get patients the most appropriate care as soon as possible. This will take many large-scale studies. Such work is expensive to do.

You have a background in mathematics.

How has this been important throughout your research career?

My work in spine research began with organising databases for various studies and analysing the data. My background in maths was a great benefit not only in this obvious application, but I think also in developing study protocols and writing papers. Mathematics requires organised, focused, persistence and stepwise critical thinking skills— these are very helpful in medical research.

You have been very involved with the North American Spine Society, currently sitting on the Board of Directors. What is the society’s greatest achievement whilst you have been on the Board?

I think one of the greatest achievements has been the recent launch of the NASS registry. It provides all spine care providers with a platform to collect data on their patients in a standardised fashion using appropriate outcome measures. The registry was designed specifically for back pain patients and can be used for non-operative as well as operative care. I also think NASS’ ongoing work in advocacy and supporting evidence based care is very important.

In addition to holding several journal positions, you were honoured as one of only nine Top Reviewers in 2016 for The Spine Journal—what did this achievement mean to you?

When I think of the high calibre of people associated with The Spine Journal, to be recognised as one of the top reviewers was great.

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

Traditionally, there have not been many women choosing to go into the sciences, including spine research. There have also been very few female spine

surgeons. In the past few years, this has been changing.

We are seeing more women getting involved, taking leadership positions in professional organisations, and becoming spine surgeons or non-operative spine specialists. I think this trend will likely continue as the opportunities increase and women continue to be successful in these roles.

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

Never sacrifice quality. Be patient, be persistent, and

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Fact File

Current roles

1986–Present: President, Texas Back Institute Research Foundation, Plano, USA 2015–Present: Board of Directors, North American Spine Society (NASS) 2015–Present: Education Publishing co-chair, North American Spine Society (NASS) 2011–Present: Research committee, International Society for the Advancement of Spine Surgery (ISASS)

Career history

1983–1985: Teaching Fellow, Department of Mathematics, North Texas State University, Denton, USA 1980–1982: Teaching Assistant, Department of Mathematics, Tarleton State University, Stephenville, USA

Education

1994–2000: Doctor of Medicine, PhD in Medical Research, Karolinska Institute, Stockholm, Sweden 1983–1985: Master of Science, University of North Texas, Denton, USA 1979–1983: Bachelor of Science with major in Mathematics, Tarleton State University, Stephenville, USA

Honours and awards

2016: Top Reviewer, The Spine Journal 2015: Best Poster Award, International Society for the Advancement of Spine Surgery (ISASS) 2012: Leon Wiltse Overall Best Paper Award, International Society for the Advancement of Spine Surgery (ISASS) 2001: Outstanding Young Alumni, Tarleton State University

always try to do the right thing. There are inevitably unanticipated obstacles when trying to execute a study; recruitment and data collection generally go slower than desired. Regardless of how good the intention, there are occasionally studies that just are not going to be executable as planned. Learn from these and apply the experience when planning future projects. Although most clinical research studies take several years to complete, it is a great feeling when a good study comes to fruition and the results are presented at conferences and published, and hopefully produces helpful information for providers to use in patient care.

I encourage everyone to get involved with professional societies. This provides a great opportunity to know more professionals in the field and gain exposure and experiences outside of your workplace.

What are your interests and hobbies outside spine?

I really enjoy working in the yard. I also like doing needlework such as counted cross stitch, and just having a good time playing cards or games with family and friends. I am interested in WWII and related history, as my father served in Europe and I also learned a lot from my mother talking about what life was like in the USA during the war.

Society memberships and committees (selected)

2018: Programme co-chair for the 2018 annual meeting, North American Spine Society (NASS) 2010–2013: US Central Regional Representative, International Society for the Study of the Lumbar Spine 2013: Basic science programme chair, 2013 annual conference, International Society for the Advancement of Spine Surgery (ISASS)

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Trauma

Whether commuting or competing, research highlights a worrying trend in spine centre referrals of cyclists Research that highlights a worrying trend between cycling and spinal trauma has recently been published in The Surgeon. Although the authors of the paper, Mark Broe (Mater Misericordiae University Hospital, Dublin, Ireland) and colleagues, state that “It is not the intention of the authors to deter participants from engaging in this sport”, the data presented convey evidence of the potential for high velocity trauma and associated major injuries.

THE HEALTH BENEFITS of cycling have been widely reported; a factor contributing to the sport’s large increase in popularity worldwide, according to Broe et al. Alongside an increase in the number of commuter cyclists, competitive road cycling and competitive long distance events have also grown in popularity, with the authors reporting triathlon being the fastest growing sport in the UK, at 10% per year.

In relation to the ever increasing popularity of cycling, the study investigators write: “There is significant benefit to be gained from research in this field for clinicians, officials and the general public.” Currently, the literature regarding cycling accidents is biased towards traumatic brain injury and the use of helmets.

Therefore, the authors note a limited number of studies that examine spinal trauma in cyclists—as there are fewer looking into the nature of spinal injury and spinal management in this cohort.

Using the number of referrals to a national referral centre for spinal trauma, Broe and colleagues took a retrospective approach in order to examine such patients. Additionally, the authors investigated whether the growing popularity of cycling (particularly at a competitive level) is linked to a significant increase in spinal trauma.

Almost all cases of spinal column disease (including trauma, degenerative and malignancy) in the Republic of Ireland are referred to the authors’ affiliated institution for either transfer or advice in relation to optimal management. A template document for each patient

was completed and made available for the institution, containing the following details: cause of injury, medical history, physical examination (objectified by the American Spinal Injury Association [ASIA] score), level of injury and relevant imaging reports.

Analysis revealed that between 2010 and 2013, the number of referrals for bicycle related trauma increased by 200%. To put this figure in context, the authors reported that referrals for car road traffic accidents increased by 29% during the same time frame, and motorcycle accident referrals even reduced by 68%.

Following this, further analyses were carried out on 24 referrals for spinal trauma in cyclists, with 19 (79%) male and five (21%) female patients, with a mean age of 44.3 years (range 16–81 years). Overall, the authors found that the majority of injuries were incurred to the cervical spine (71%), with 29% to thoracic spine and no

lumbar or sacral spine injuries. Five patients (20.8%) had neurological deficit with 12.5% complete paralysis ASIA A score. The spinal fixation rate was 29.1%, with 16.6% managed with a HALO device. Additionally, the analysis revealed that the most seriously injured patients (complete spinal cord injury) were injured whilst training on a racer style bicycle.

Although the data presented highlight a worrying trend, showing an increase in spinal trauma secondary to bicycle use, Broe et al note some limitations of the study; the main being the use of a single institution.

However, irrespective of the study’s shortcomings, the findings remain in-line with previous retrospective analyses. The largest study that looked at competitive cycling (using 107 patients from 1995–2007) also found that the majority of injuries (73%) were of the cervical spine. Additionally, epidemiological studies from France maintain that spinal cord injury due to cycling is on the rise; Lieutaud and colleagues (Service d’Anesthésie Réanimation, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre Bénite Cedex, France) found a 77% increase within six years (2003–2008).

In light of this increase in spinal trauma due to cycling accidents, Broe and colleagues advocate for an increased emphasis on cyclist safety through public awareness campaigns aimed at those participating in the sport, as well as further large, multicentre studies examining injuries associated with cycling accidents and the impact of educational programmes.

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Minimally invasive spinal fusion comparable to conventional open revision techniques Clinical outcomes of minimally invasive lumbar interbody fusion revisions were found to be similar to those of primary surgery, concluded a recent study. Virginie Lafage, Hospital for Special Surgery (New York, USA), who presented the data at the North American Spine Society (NASS) annual meeting (24–29 September, Los Angeles, USA), further concluded that this form of minimally invasive fusion may be a comparable alternative to conventional open revision, given that post-operative clinical outcomes were also similar between minimally invasive and open fusion patient groups. There were similar complication risks for both open and minimally invasive techniuqes, lending further credence to the idea that minimally invasive fusion procedures area viable alternative option.

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ccording to Lafage, more and more physicians are turning to minimally invasive techniques for lumbar fusions, as opposed to open fusions. Regarding the overall literature, it is clear that such minimally invasive methods are associated with less blood loss, lower follow-up VAS scores, shorter peri-operative length of stay and non-inferior fusion rates. Furthermore, Lafage pointed to evidence that suggested that with increased fusion length in minimally invasive methods, a decreased number of returns were observed.

In terms of primary versus revision fusion, Lafage reported that recent data depicted similar outcomes between open primary and revision lumbar interbody fusions. However, minimally invasive revisions have also been associated with increased rates of minor peri-operative complications in previous studies.

Prior to the current study, Lafage suggested that the utility of minimally

invasive techniques for revision surgery was not well established in the literature, with few studies comparing the peri-operative outcomes of primary minimally invasive fusion surgery to those of minimally invasive interbody fusion revisions.

For this reason, Lafage and colleagues set out to assess the differences in peri-operative outcomes between primary and revision minimally invasive lumbar interbody fusion patients, in order to compare them to those undergoing corresponding open procedures. The study included 154 patients undergoing lumbar interbody fusion, matched for comorbidities and levels fused.

The patient cohort undergoing minimally invasive fusion (n=44; mean age: 59, mean BMI: 30) was comprised of 59.1% undergoing primary, and 40.9% undergoing revision fusion, with no baseline differences observed in terms of surgical approach or demographics.

The cohort receiving open fusion (n=110; mean age: 63, mean BMI: 29) included 46.4% of patients receiving primary, and 53.6% revision, again with no differences at baseline.

Furthermore, no significant difference in operative factors, including levels fused, laminectomy rates, number of interbodies, operative time and estimated blood loss, were observed between primary and revision cases within the minimally invasive or open fusion cohort. However, Lafage noted that open revisions displayed a trend of greater estimated blood loss compared to open primary fusions (789±686 vs. 1037±197, p=0.179).

In terms of the clinical outcomes analysed, the minimally invasive primary fusion patients had more overall intraoperative complications compared to the revision cases (19.2% vs. 0%, p=0.048). In addition, open revision patients developed more intraoperative and postoperative complications compared to open

primaries, although Lafage noted that this did not reach statistical significance (p=0.058). Although no significant differences were observed between groups regarding cardiac, pulmonary, urinary, infection, or anaemic complications; minimally invasive revisions were shorter when compared to open revisions (244 vs. 296 minutes, p=0.024).

These data led Lafage to conclude that clinical outcomes of revision minimally invasive lumbar interbody fusion were similar to those of primary surgery. In addition, despite higher intraoperative complication rates for primary minimally invasive fusion, post-operative clinical outcomes were similar between minimally invasive fusion and open groups—in terms of both primary and revision surgery.

In light of these findings, Lafage suggested that minimally invasive lumbar interbody fusion may be a comparable alternative to conventional open revision.

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The Global Spine Congress heads to North America

DON’T MISS OUT! EARLY BIRD REGISTRATION CLOSES DECEMBER 20

Global Spine Congress Toronto, Canada | May 15–18, 2019 www.gsc2019.org • #GSCToronto

© 2018 AOSpine International. All rights reserved. E & OE.

GSC 2019 Toronto AD SIZES.indd 5

16/10/2018 11:59

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Spinal cord injury

Quality of life after spinal cord injury: Having independent mobility makes the greatest impact

Independence in mobility is the single most important factor affecting quality of life in patients with traumatic spinal cord injury, reports a study in the American Journal of Physical Medicine & Rehabilitation, the official journal of the Association of Academic Physiatrists.

BASED ON VALIDATED clinical questionnaires, the study by Julien Goulet and colleagues (Hôpital du Sacré-Coeur de Montréal, Montréal, Canada) is the first objective evaluation of the relative importance of specific functional abilities following traumatic spinal cord injury. “Our findings could help clinicians to guide the rehabilitation plan based on importance of specific functional abilities in relationship with healthrelated quality of life,” the researchers write.

Study shows different priorities for traumatic spinal cord injury patients with tetraplegia versus paraplegia

The study included 195 patients with traumatic spinal cord injury admitted to the authors’ specialised trauma centre between 2010 and 2016. Most were injured

in falls or motor vehicle accidents; about 65% were tetraplegic, with paralysis of both the upper and lower limbs; and 35% were paraplegic, with paralysis of the lower limbs only.

Six to 12 months after injury, the patients completed a standard questionnaire (Spinal Cord Independence Measure, or SCIM) to evaluate the level of independence in 19 functional abilities related to activities of daily living. Another questionnaire (Short Form-36) was used to assess health-related quality of life, including physical and mental components. Quality of life has become a major focus of outcome evaluation for patients with spinal cord injury and other chronic conditions.

Associations between these widelyused questionnaires were analysed to determine which areas of functional ability had the greatest impact on quality of life after traumatic spinal cord injury. As in previous studies, total scores on the SCIM and quality assessments were significantly correlated with each other.

The study revealed some differences in the most important functional abilities for traumatic spinal cord injury patients with tetraplegia versus paraplegia. Overall, factors on the mobility subscale of the SCIM had the largest effect on the physical component of quality of life, followed by the self-care and respiration/sphincter management subscales. This trend was strongest among tetraplegic patients.

In contrast, for paraplegic patients, mobility was the only SCIM subscale significantly correlated with

Spinal injuries in suicidal jumpers “differ in many aspects” to nonsuicidal patients New research outlines how spinal injuries in suicidal jumpers differs from those in non-suicidal patients with regard to patient demographics, mental health condition, injury location, neurological damage and associated injuries. The study was carried out by Hiroki Kano and colleagues from Osaka General Medical Center (Osaka, Japan), and has been recently published in Spine.

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ccording to the authors, previous research indicates that spinal injuries are seen in half of survivors of suicide jumping; of which are known to display common characteristics.

Alongside a large proportion of suicide jumpers having a psychiatric diagnosis, they are predominantly male, middle-aged, unemployed and single. Yet, irrespective of these demographics, the authors note that the aetiology of spinal injuries in suicide jumpers is not well understood.

Furthermore, Kano et al emphasise the importance of clinicians being well-versed in the characteristics of spinal injuries in suicide jumpers; they write: “Traumatic suicidal jumping is no longer rare because the number of patients with mental health problems is increasing.”

The retrospective case series, carried out at a single institution, was performed to investigate the characteristics of spinal injuries in survivors of suicide jumping.

Kano et al identified 87 survivors of suicidal jumping who sustained

spinal injuries from 2007 to 2016. The demographic data, mental health condition, neurological status, injury location, associated injuries and treatments were compiled and compared between the survivors and non-suicidal patients with spinal injuries (n=204).

Patients’ mental health condition was evaluated by interviewing patients, checking their use of tranquilisers or antidepressants, and assessing their history of mental illness, while neurological status was evaluated using the American Spinal Injury Association Impairment Scale (AIS) at the time of admission. The spinal injuries themselves were evaluated by whole-body helical computed tomography.

Of the total number of patients with spinal injuries, 196 were male and 95 were female (with a mean age of 47.5 years). However, suicide jumpers were predominantly female (67%) and 10 years younger than non-suicidal patients (mean age of 40.3 and 50.5, respectively).

Mental health problems were diagnosed

the physical quality of life score. That was consistent with previous studies reporting the high priority for walking among traumatic spinal cord injury patients with paraplegia.

In both groups, indoor and outdoor mobility was more important for physical quality of life, compared to other measures of mobility (such as managing stairs or transferring from bed to wheelchair). The greater importance of self-care abilities in traumatic spinal cord injury patients with tetraplegia reflected the importance of arm and hand function for daily activities like bathing, dressing, and grooming.

Scores for functional abilities on the SCIM were not strongly related to the mental component of quality of life. “These findings suggest that mental health after a traumatic spinal cord injury strongly depends on other factors that were not considered in the current study,” the researchers write.

Previous studies have evaluated the importance of different functional abilities after spinal cord injury, but have mainly relied on subjective patient assessments. The new study provides a more objective look at the factors most important to quality of life for traumatic spinal cord injury patients with injury to different spinal cord levels.

“Our study showed that it is of paramount importance to analyse tetraplegic and paraplegic patients distinctly when evaluating the impact of function on quality of life,” Goulet and co-authors write. “Different priorities for patients lead to distinct goals in the rehabilitation effort.”

in 66 (77%) of 87 suicidal jumpers, with a large proportion of patients found to have schizophrenia (29%) and depression (29%). Comparisons of neurological deficits found that spinal trauma was generally less severe in suicidal jumpers than in non-suicidal patients.

The majority of spinal injuries in suicidal jumpers were located in the thoracic or lumbar spine region, whereas cervical spine injury was observed in 49% of patients who had accidentally fallen compared with 15% of suicidal patients. Neurological deficits in suicidal jumpers were rare compared with those in non-suicidal patients regardless of injury location. Among comorbid injuries, extremity injuries were highly associated with spine injury in contrast to 33% of nonsuicidal patients.

Furthermore, approximately 25% of suicidal jumpers underwent surgical treatment. Interestingly, surgical treatment

was similarly performed on suicidal jumpers and non-suicidal patients regardless of the discrepancy in neurological damage between the two groups.

In conclusion, the authors write: “Spinal injuries differ in many aspects between suicidal jumpers and non-suicidal patients.”

Kano et al’s study investigates survivors of suicidal jumping that were young, predominantly female with mental health problems—the majority of which tended to have thoracic and lumbar spine trauma compared with cervical trauma with less severe neurological deficits and a higher incidence of accompanying limb injury.

As recent research outlines that suicide is the eighth most frequent cause of death in Japan—with more than 23,000 fatalities a year—the authors reiterate the importance of well-advised clinicians, as spinal injuries in suicidal survivors are only expected to increase.

Suicidal jumpers exhibited a higher incidence of thoracic or lumbar injury.

In contrast, cervical spine injuries were rarely observed in suicidal jumpers compared with non-suicidal patients.

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Basic science

New therapy spurs nerve fibres to regrow through scar tissue and transmit signals after spinal cord injury in rats Neuroscientists at UCLA, Harvard University and the Swiss Federal Institute of Technology have identified a three-pronged treatment that triggers axons to regrow after complete spinal cord injury in rodents. In addition to facilitating axon growth through scar tissue, the treatment enabled the transmission of signals across the damaged tissue, the Nature publication reports.

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f researchers can produce similar results in human studies, the findings could lead to a therapy to restore axon connections in people living with spinal cord injury.

“The idea was to deliver a sequence of three very different treatments and test whether the combination could stimulate disconnected axons to regrow across the scar in the injured spinal cord,” says lead author Michael Sofroniew (David Geffen School of Medicine, University of California Los Angeles, USA). “Previous studies had tested each of the three treatments separately, but never together.

The combination proved to be the key.”

According to Sofroniew, many decades of research have shown that human nerve fibres need three things to grow: genetic programming to switch on axonal growth; a molecular pathway for the fibres to grow along; and a protein trail that entices the axons to grow in a particular direction. All three of these conditions are active when humans develop in the womb. After birth, these processes shut down, but the genes that control the growth programmes are dormant. Sofroniew’s goal was to re-start gene expression.

First, the researchers reactivated nerve cells in the spinal cords of mice by injecting a treatment packaged in a viral vector initially developed in the lab of Zhigang He (Harvard University, Cambridge, USA).

Two weeks later, the UCLA team anaesthetised the animals and disconnected the axons in their lower spinal cords. Only the rodents’ hind legs were affected and they could still move and feed.

Two days after injury, the team administered a second treatment into the lesion to create new pathways on which axons prefer to grow. Finally, the researchers released a third set of molecules called chemo-attractants. The axons target these chemo-attractants, and therefore the spinal cord tissue remaining on the other side of the scar from the injury.

When Sofroniew and his colleagues examined the tissue of mice who underwent the three-part treatment, they were jubilant. “Not only had axons grown robustly through the scar tissue,” Sofroniew recalls, “but many fibres had penetrated into the remaining spinal cord tissue on the other side of the lesion and made new connections with neurons there.”

Animals who did not undergo the combined treatment exhibited no axon regrowth across the injury lesion.

To test the reproducibility of their findings, the team repeated the experiment multiple times in mice at UCLA and in rats in the lab of Swiss neuroscientist Gregoire Courtine (Swiss Federal Institute of Technology

Lausanne, Lausanne, Switzerland). The results proved equally robust.

Sofroniew and colleagues received another surprise when they tested whether newly regrown axons could conduct

electrical activity in live animals. “When we stimulated the animal’s spinal cord with a low electrical current above the injury site, the regrown axons conducted 20% of normal electrical activity below the lesion,”

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comments Sofroniew. “In contrast, the untreated animals exhibited none.”

Despite the finding suggesting that the newly formed connections can conduct signals across the injury, the rodents’ ability to move did not improve. This was not unexpected, according to Sofroniew.

“We expect that these regrown axons will behave like axons newly grown during development—they do not immediately support coordinated functions,” explains Sofroniew. “Much like a newborn must learn to walk, axons that regrow after injury will require training and practice before they can recover function.”

The research team will next explore how to retrain newly wired circuits to restore movement.

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Neuromodulation enables independent stepping in a spinal cord patient

Megan L Gill (Rehabilitation Medicine Research Center, Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, USA) and others report in Nature Medicine that a patient who had a complete loss of lower extremity sensorimotor function after a spinal cord injury was able to independently bilaterally step on a treadmill—without assistance from a trainer or a bodyweight support system—following dynamic task-specific training in the presence of epidural electrical stimulation (multimodal rehabilitation) for 43 weeks.

Gill et al add that the patient was also able to step over ground while using a front-wheeled walker with trainer assistance at the hips (to maintain balance). According to the authors, their study represents the first report of multimodal rehabilitation (in this format) being associated with independent stepping in a patient with complete loss of lower extremity sensorimotor function.

In a separate study, Kajana Satkunendrarajah (Krembil Research Institute, University Health Network, Toronto, Canada) reports in Nature that after assessing a combination of pharmacogenetics and respiratory physiology assays in different models

of spinal cord injury, they were able to show that mid-cervical excitatory interneurons are essential for the maintenance of breathing in mice with non-traumatic cervical spinal cord injury and are also crucial for promoting respiratory recovery after traumatic spinal cord injury. They conclude that their results “demonstrate a strategy to restore breathing after central nervous system trauma by targeting a neuronal subpopulation”. In a Krembil Research Institute press release, Satkunendrarajah comments: “We think this discovery has big implications for neuroscience in general, as it demonstrates an important role for this neuronal population in the complex respiratory neural network.”

“Double trolley” surgery performed for the first time

In May 2018, Lee Breakwell and eight of his colleagues at the Sheffield Children’s Hospital (Sheffield, UK) not only performed the first-ever “trolley” surgery in Europe, they also performed the first-ever “double trolley” surgery in the world. The procedure was part of an ongoing international study that is evaluating trolley surgery for the management of scoliosis in children (in 17 patients).

A Sheffield Children’s Hospital press release reports that the aim of trolley

surgery is to realign the curve with the use of growing rods (Trolley system, DePuy Synthes), which are designed to “grow” with the child as they get older.

It adds that the surgery has only been performed at three institutions worldwide and takes between five and six hours

BIBA Briefings is a new platform that provides in-depth analysis of the latest market intelligence from BIBA MedTech Insights, which provides consulting and market analysis services to medical professionals and organisations in the medical device industry in Europe and North America. The platform also reviews data and news.

The aim of each report is to give an overview of the key information affecting the medical device industry, enabling those working in the industry to keep abreast of the latest developments and make knowledgeable decisions.

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

The global spinal implants market is forecasted to grow at a 7% compound annual growth rate to exceed US$19.5 billion by 2024, according to a recent Market Research Engine report.

Drivers for growth include an ageing population, a rise in traumatic spinal cord injuries, and increasing use of novel technologies. he growth of bioresorbable implants is expected to propel the spinal implants market forward.

The report states: “The present advancement of bio-resorbable inserts that naturally leave the body as the patient recoups is anticipated to accelerate the development of the spine implant market.

Spinal inserts are utilised to remedy disfigurements, reinforce the spine, and encourage combination. A portion of the significant conditions that require spine implants are interminable degenerative disc illness, spondylolisthesis, scoliosis, awful crack, and different types of spinal hazards.”

According to the authors, one of the key drivers of the spinal implant market is the escalation of the geriatric population susceptible to spinal ailments. It is well established that the world’s population is ageing: virtually every country in the world is experiencing growth in the number and proportion of older persons in their population, according to the United Nations.

Data from World Population Prospects: the 2017 Revision reveal that the number of people aged 60 years or over is expected to more than double by 2050 and to more than triple by 2100, rising from 962 million globally in 2017 to 2.1 billion in 2050 and 3.1 billion in 2100. Globally, population aged 60 or over is growing faster than all younger age groups. This adds a burden to spinal cords: an increase in elderly people

to complete.

In this particular case, the patient—a nine-year-old boy—had a 96-degree curve in his spine; this meant that his both lungs and heart were under pressure, causing breathing problems, and surgery was needed to prevent the curvature becoming worse. Breakwell et al inserted the growing rods parallel to the spine to act as an anchor for the spine to sit against. Unlike the generic trolley procedure, which only requires four rods, they had to use six rods (representing a world first) because of the severity of the patient’s curve. Following the surgery, the patient was two inches taller and was able to easily do activities such as jumping, running, and playing football.

Breakwell comments: “We are constantly looking for ways to improve outcomes for our patients with scoliosis.

This innovative surgery is another in the long line of groundbreaking work we are doing for the children and families we care for.”

BIBA Briefings

Spinal implants market to exceed US$19.5 billion by 2024

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Market insights

means a concordant increase in the incidence of agerelated degenerative diseases such as osteoporosis.

Additionally, the number of traumatic spinal cord injuries from low falls in the elderly are increasing in the majority of countries with ageing populations.

This contributes to the second driver of market growth highlighted in the report: the raised rate of spinal cord injuries and disorders. A 2017 paper estimated that the proportion of traumatic spinal cord injury from land transport is decreasing or stable in developed nations, but is increasing in developing countries due to trends in transport mode (transition to motorised transport), poor infrastructure and regulatory challenges.

First author Bon Lee (Spinal Medicine Department, Prince of Wales Hospital; Neuroscience Research Australia, University of New South Wales, both Sydney, Australia) and colleagues wrote: “The proportion of traumatic spinal cord injuries resulting from land transport (four-wheeled vehicles) is stable or decreasing in developed countries, but on the increase in developing countries. The relatively smaller proportion of traumatic spinal cord injury due to land transport in developing countries belies the extent of the problem, owing to the growing number of people being (preventably) injured and poorer survival to hospital.”

A third cause for the expected expansion of the

spinal implant market is the increasing use of recent technologies in spinal devices. One of the most promising areas for growth is robotic-assisted surgery in spine procedures. Medtronic recently acquired Mazor Robotics, following its stint as the exclusive worldwide distributor of the Mazor X system over the last year. To date, more than 80 Mazor X systems have been installed since launch. The use of robotics in spine surgery necessitates the integrated use of other technologies, such as pre-surgical planning software, a robotic arm, intraoperative 3D imaging, navigation, and powered instruments. As well as Medtronic’s Mazor offering, Stryker, Zimmer-Biomet, and Globus Medical all have their own robots. Globus has the ExcelsiusGPS robotic system, Stryker sells the Mako, and Zimmer-Biomet owns the Rosa Spine.

A fourth contributing factor to the forecast growth in the spinal implants market is the huge demand for surgery, due to quicker recovery times and lesser discomfort than in previous years.

However, the report also lists a number of restraining factors acting on the global spinal implants market. These include: absence of proper diet and exercise and the resultant decline in bone density; scarcity on the emerging and low-income economies; growing prevalence of postural defects; and monetary concerns affect the market growth.

The report lists the following companies as key players in the global spinal implants market (note this is not an exhaustive list): Medtronic, DePuy Synthes Stryker NuVasive Zimmer Biomet Globus Medical Orthofix LDR Holding

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Market watch

Industry News Benvenue Medical completes divestiture of its vertebral augmentation systems portfolio

Benvenue Medical, a developer of minimally invasive expandable implant solutions for lumbar fusion, has announced it has completed the divestiture of its vertebral augmentation systems portfolio for an undisclosed amount to IZI Medical Products. A company press release states that the completion of the sale of this business allows Benvenue Medical to devote its full resources to accelerating growth opportunities in the market for its Luna 3D interbody fusion system.

The divested portfolio includes the Kiva VCF [vertebral compression fracture] treatment system, Kiva Pilot and Blazer vertebral augmentation system devices.

“IZI Medical’s acquisition of the Kiva and associated VCF product franchise allows us to singularly focus on our minimally invasive spinal implant and procedure product line,” says Robert K Weigle, CEO of Benvenue Medical.

“Our best-in-class Luna 3D expandable interbody system is an ideal minimally invasive expandable spinal implant and platform technology, enabling Nitinol, PEEK and Titanium materials to be combined in a procedural solution for degenerative disc disease that can be treated in either the hospital or the ambulatory surgery centre setting.”

Benvenue Medical also announced the addition of its new Orbit discectomy instrumentation that facilitates a circumferential and comprehensive discectomy and endplate preparation to achieve a fusion. This novel new tool kit can be used in open and minimally invasive surgery with the Luna 3D implants, including compatibility with a variety of surgical fusion approaches.

Benvenue Medical is privately held and funded by CRG.

EOS imaging installs its first site in Mexico

EOS imaging, a 2D/3D imaging company for orthopaedics, has announced the first installation of an EOS system in Mexico, the largest Central American market, at Shriners Hospitals for Children— Mexico, located in Mexico City.

“Shriners Hospitals for Children— Mexico, noted for excellent paediatric specialty care, modern medical technology and exceptional personnel, is proud to bring the EOS technology to our facility,” says Mariano Gonzalez Lugo, the hospital administrator.

“The ability to obtain full-body, weight-bearing images of our patients will further enhance the orthopaedic care we provide. In addition, the EOS system produces images with far less patient exposure to radiation than conventional X-rays. Our patients deserve safe, quality imaging and this is an important step in

the right direction.”

Established in 1945, Shriners Hospital for Children—Mexico today has 80 beds and four operating rooms to treat patients up to 18 years of age for general paediatric orthopaedics, including upper- and lower-extremity surgeries, spine surgeries and bone lengthening and correction surgeries.

“We applaud the Shriners Hospitals for Children for their commitment to safe imaging and are excited to see our footprint expand into Mexico,” comments Marie Meynadier, CEO of EOS imaging.

“This is the first facility to adopt our system in Mexico City, serving more than 12 million inhabitants. It marks a significant step towards making our solutions available to Central American patients and healthcare providers.”

This follows the recent 20th installation of the EOS imaging system in a University hospital in the USA, and the 15th installation of an EOS imaging system in Australia.

J&J acquires 3D-printed spinal implant maker EIT

Johnson & Johnson has announced its acquisition of spinal fusion implant developer Emerging Implant Technologies for an undisclosed amount.

Norderstedt, Germany-based EIT produces 3D-printed titanium interbody implants specifically for spinal fusion surgery. The company’s devices use proprietary cellular titanium which J&J said consists of an open and interconnected porous structure intended to promote bone growth into the implant.

Johnson & Johnson said that the acquisition will enhance its subsidiary DePuy Synthes‘ interbody implant portfolio, and that EIT’s technology complements its existing spinal interbody implant segment.

“Our goal is to offer a complete portfolio of interbody solutions that provides surgeons with even more options for the treatment of their patients.

We are excited to welcome the skilled team at EIT, and together, we aspire to bring to market technologies that allow surgeons to perform spinal fusion procedures reliably and with consistent outcomes,” said J&J DePuy Synthes group chair, Aldo Denti.

In May, J&J’s DePuy Synthes said it launched the Global Unite reverse fracture shoulder implant designed for shoulder reconstruction procedures following complex fractures in patients with grossly deficient rotator cuffs.

Medtronic to acquire Mazor robotics

Medtronic and Mazor Robotics have announced that the two companies have entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for US$58.50 per American Depository Share, or US$29.25 (104.80

ILS) per ordinary share, in cash, for a total of approximately US$1.64 billion, or US$1.34 billion net of Medtronic’s existing stake in Mazor and cash acquired. The boards of directors of both companies have unanimously approved the transaction.

Mazor’s proprietary core platform technology, including the Mazor X Robotic Guidance System (Mazor X), and the Renaissance Surgical-Guidance System (Renaissance), are transforming spinal surgery from freehand procedures to accurate, state-of-the-art, guided procedures. By combining Medtronic’s spine implants, navigation, and intraoperative imaging technology with Mazor’s robotic-assisted surgery systems, Medtronic intends to offer a fully-integrated procedural solution for surgical planning, execution and confirmation. The companies showcased this technology integration at the NASS (North American Spine Society) 2018 Annual Meeting (26–29 September, Los Angeles, USA).

“We believe robotic-assisted procedures are the future of spine surgery, enhancing surgeons’ abilities to perform complex procedures with greater precision, consistency and control. Medtronic is committed to accelerating the adoption of robotic-

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Mazor X systems since launch. With this announcement bringing the two companies together, Medtronic aims to accelerate the advancement and adoption of robotic assisted surgery in spine to the benefit of patients, providers, and the healthcare system more broadly.

“This is a historic day for spine surgery and a defining event in the market’s evolution, and I want to acknowledge and thank all of those whose contribution and faith have been so critical and impactful to our success,” says Ori Hadomi, CEO of Mazor Robotics. “The Mazor team and product portfolio’s full integration into Medtronic will maximise our impact globally through Medtronic’s channels, advance our systems’ leadership position in the marketplace, and drive the realization of our vision to heal through innovation.”

The acquisition is expected to close during Medtronic’s third fiscal quarter ending 25 January, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders. 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, a press

J&J acquires 3D-printed spinal implant maker EIT

assisted surgery and transforming spine care through procedural solutions that integrate implants, biologics and enabling technologies,” says Geoff Martha, executive vice president and president of the Restorative Therapies Group at Medtronic. “The acquisition of Mazor adds robotic-assisted guidance systems to our expanding portfolio of enabling technologies, and we intend to further cultivate Mazor’s legacy of innovation in surgical robotics with the site and team in Israel as a base for future growth.”

This transaction builds on a relationship originated in May 2016 under a multi-phased strategic and equity investment agreement between Medtronic and Mazor. In August 2017, Medtronic expanded the partnership to become the exclusive worldwide distributor of the Mazor X system, leading to the successful installation of more than 80

release claims.

Consistent with its long-term financial objectives, Medtronic projects the acquisition to generate a double-digit return on invested capital by year four, with an increasing contribution thereafter.

Medtronic’s financial advisors for the transaction are Parella Weinberg Partners and Goldman Sachs, with Meitar Liquornik Geva Leshem Tal and Ropes & Gray acting as legal advisors.

To date, more than 200 Mazor systems are in clinical use on four continents, and have guided the placement of more than 250,000 implants during some 40,000 procedures, enabling minimally-invasive spine surgery to become standard procedure in many hospitals. Mazor’s core technology has received more than 15 US Food and Drug Administration clearances and has been the subject of more than 60 publications, leading the

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Industry News spine robotics market on the evidence front. Mazor is the holder of more than 50 patents worldwide.

France’s national healthcare system establishes exclusive positive coverage for the triangular iFuse Implant System for MIS SI joint fusion

SI-Bone has announced that iFuse will be added to the List of Refundable Products and Services in France (LPPR), meaning that the French National Healthcare System will exclusively cover the iFuse procedure. Through the iFuse Implant System, the product has already been used in the minimally invasive surgical treatment of the sacroiliac (SI) joint.

Reimbursement, which is exclusive to the iFuse implant, has been established following the favourable opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS), begins 6 September, 2018 and is effective for an initial period of five years.

The CNEDIMTS concluded on 5 December, 2017, that the iFuse procedure’s observed outcomes, including improvements in quality of life and work status, are sufficient to include iFuse on the list of products and services provided for in Article L.165-1 of the Social Security Code.

The Commission recommends brand name registration for the iFuse Implant System with the following indications: second-line treatment of sacroiliac joint dysfunction caused by sacroiliac joint disruption, or degenerative sacroiliitis in patients who fail to respond to conservative treatment.

Before treatment with iFuse, a diagnosis of unilateral or bilateral SI joint dysfunction must have been confirmed with positive responses to at least three out of the five SI joint provocative manoeuvres (iliac wing spacing test [distraction], iliac wings approximation test [compression], the vertical compression test of each SI joint [thigh thrust], the sacral test [Faber] and the shear test of the two supine SI joints [Gaenslen]), and a positive response to palpation of the SI joint. Patients who meet the above criteria may experience relief from diagnostic injections with anaesthetics and/or corticosteroid injections in the sacroiliac joint. If the clinical response to an anaesthetic injection is significantly positive, the sacroiliac joint may be considered as the source of the pain, and treatment with iFuse is indicated in the absence of any contraindications.

The commission recommends reserving the use of the iFuse Implant device to surgeons who are accustomed to using image-guided surgery and who have received specific training on the iFuse procedure.

Stryker acquires Invuity and K2M Medical Stryker has announced a definitive

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merger agreement to acquire all of the issued and outstanding shares of common stock of K2M Group Holdings, a company specialising in minimally invasive spinal devices, for US$27.50 per share, or total equity value of approximately US$1.4 billion. In addition, Invuity, a medical technology company focused on advanced surgical devices to enable better visualisation, announced that it has entered into a definitive agreement with Stryker, pursuant to which Stryker will acquire all of the outstanding shares of Invuity for US$7.40 per share in cash, implying a total equity value of approximately US$190 million.

“Joining Stryker will be a very exciting next chapter for our global team and surgeon customers around the world,” says Eric D Major, chairman, chief executive officer, and president of K2M. “Stryker’s established leadership in the orthopaedic and neurosurgical market, combined with K2M’s culture of innovation and leadership in complex spine and minimally invasive solutions, represent a powerful opportunity for Stryker to strengthen its leadership in the US$10 billion global spine market.”

The closing of the transaction is subject to expiration or termination of the applicable waiting period under the HartScott-Rodino Antitrust Improvements Act, approval of the merger by K2M’s stockholders and other customary closing conditions. Upon closing of the transaction, it is expected that Eric D Major will serve as president of Stryker’s Spine division and lead the combined business. Bradley W Paddock, the current president of Stryker’s Spine division, will assist with transitioning his responsibilities to Major, while also supporting the integration efforts.

The acquisition of K2M is expected to close late in the fourth quarter of this year and is expected to have an immaterial dilutive impact to Stryker’s net earnings per diluted share and adjusted net earnings per diluted share in 2018.

Of the Invuity acquisition, Scott Flora, Invuity’s interim CEO, comments, “The combination of Stryker’s established leadership in minimal access surgery paired with Invuity’s suite of enabling visualisation and surgical devices should facilitate better patient outcomes and operating room efficiencies in women’s health, general surgery, electrophysiology and orthopaedics.

It is with this in mind that Invuity’s Board of Directors voted to recommend this transaction to Invuity’s stockholders.”

Under the terms of the definitive transaction agreement with Invuity, a subsidiary of Stryker will commence a tender offer to purchase all outstanding shares of Invuity common stock in exchange for US$7.40 per share in cash.

The completion of the tender offer is subject to customary terms and closing conditions, including a requirement that a majority of Invuity’s outstanding shares

are tendered in the offer and receipt of certain regulatory approvals. The agreement provides that immediately following the successful completion of the presented offer, the subsidiary of Stryker making the offer will merge with and into Invuity, and all remaining outstanding shares of Invuity common stock that were not tendered in the offer will receive the same consideration paid in respect of those shares that were tendered. Stryker intends to fund the transaction with cash on hand.

The Invuity Board of Directors has approved entering into the agreement and recommends that Invuity’s stockholders sell their shares in the upcoming tender offer. All directors and executive officers of Invuity have entered into a tender and support agreement providing that they will tender their shares in the offer.

There is no change to Stryker’s previously announced expected adjusted net earnings per diluted share for the full year, which is a range of US$7.22–$7.27.

For 2019 and beyond, Stryker reaffirms its previously stated long-term financial goals for sales, operating margins and adjusted net earnings per diluted share.

NICE draft guidance “minded no” for access to Spinraza for SMA treatment disappoints Biogen UK’s National Institute for Health and Care Excellence (NICE) has published its Appraisal Consultation Document (ACD) outlining a “minded no” for the routine funding of Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA) in England, Wales and Northern Ireland. SMA is a debilitating and lifethreatening muscle-wasting rare disease.

Children with the most severe form of SMA rarely live to see their second birthday.

Terry O’Regan, vice president and managing director of Biogen UK and Ireland, says: “We are very disappointed that NICE has issued a ‘minded no’, however we are not surprised given the challenges of assessing rare disease medicines via the standard technology appraisal (STA) route, and our expressed reservation of the suitability of this route for evaluating medicines such as nusinersen. Sadly, this decision and the lengthy timeframe of the whole process highlights the UK challenge in providing access to rare disease medicines in a timely manner, similar to other leading economies. To date, 20 European countries including Scotland (and more across the world) have already made nusinersen available. We share the concerns of the SMA community, and remain focused on finding a way to make this important treatment available to patients who may benefit throughout the UK as soon as possible. We urge NICE and NHS England to continue to work with us on agreeing the terms of a managed access agreement (MAA) so that patients in England, Wales and Northern Ireland can share equality in access compared to other countries across Europe and the world.”

NICE began assessing nusinersen via its STA route in January 2018 after an 8-month delay in the decision regarding

whether it would consider the treatment via its STA process which all medicines are subject to, or its ‘Highly Specialised Technologies’ (HST) route which is intended to provide greater flexibility for innovative medicines to treat rare diseases. The STA is not designed for rare diseases, and Biogen has continually maintained that this process is unsuitable for nusinersen. Latest data suggests almost 50% of rare disease medicines receive reimbursement in England, and on average it takes two years from marketing authorisation to access.

Nusinersen received orphan status from the FDA and the European Medicines Agency (EMA) and is being reviewed by many health services across the world as a specialised medicine. The NHS in Scotland has already made nusinersen routinely available to patients with type 1 SMA, and their reformed process which comes into effect on the 1st October 2018 will see it also consider the medicine for types 2 and 3.

The draft ACD shared recently noted the clinical benefit of nusinersen, and the urgent need for a medicine to treat SMA, but concluded that the extent of the overall benefit remained uncertain, particularly due to the lack of available long-term data. Absence of long-term data is typical of any recently introduced rare disease medicine, Biogen state in a press release, and the nusinersen clinical development programme is the largest body of evidence for an interventional approach in SMA, with over five years of data. In addition, other challenges cited include cost effectiveness measures, which rely heavily on quality of life—an extremely difficult measurement in a population dominated by infants and young children. Such challenges are common for rare disease medicines, especially if they are the first treatment available.

Biogen will be responding to the specific points raised in the ACD to clarify and provide further clinical and economic evidence for nusinersen, and are fully prepared to work alongside NICE and the NHS to address budget impact, sustainability and risk-sharing to manage the access to nusinersen appropriately.

However, collaboration and flexibility on how the above challenges are addressed within the STA process will be central to the achievement of an MAA. Biogen’s ambition remains focused on securing access to nusinersen for all those who could benefit from the treatment.

O’Regan continues: “We understand the financial pressure that many health systems are under and are committed to working collaboratively with NICE, the NHS, and representatives from the clinical and patient community to find a solution to the access challenge. We have already made positive strides towards a MAA framework even before we received the draft guidance, and now is the time to accelerate this outside of the restrictive parameters of the STA process.

We urge both parties to rapidly work with us and other stakeholders to agree the details of a MAA within the planned timeframe originally set out by NICE, so that patients in desperate need do not continue to live in uncertainty”

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Captiva Spine’s TirboLOX-L 3D printed titanium lumbar cages receives FDA clearance

Captiva Spine has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its TirboLOX-L 3D printed Titanium lumbar cages.

TirboLOX-L titanium lumbar cages are created using advanced 3D printing technologies to form titanium alloy interbody fusion devices with a dual layer organic lattice structure. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture. Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony ongrowth, in-growth and vascularisation.

TirboLOX-L’s open architecture is designed to reduce radiographic presence for clear imaging, and its high friction coefficient creates immediate bidirectional fixation, a company press release states.

Dennis Ty, director of research and development at Captiva Spine, comments, “With the advanced capabilities of 3d additive manufacturing, we were able to create a unique lattice structure similar to trabecular bone incorporating a micro-rough surface for clot retention and early osteogenic cell migration, including a dual layer of porosity with pore sizes specifically designed to promote bone in-growth and vascularisation. Through substantial surgeon design input we are able to deliver TirboLOX-L’s unique dual layer organic lattice structure with numerous geometries and sizes that appeal to a wide range of surgeon preferences.”

CoreLink announces the launch of articulating expandable posterior lumbar system: FLXfit15 CoreLink have announced the expanded commercial launch for the FLXfit15 articulating-expandable intervertebral body fusion device.

FLXfit15 is a posterior lumbar expandable interbody device that offers up to 15 degrees of controlled and continuous expansion and is one of the only expandable cages on the market that offers articulation, providing ease in precise anterior placement. FLXfit15’s open device architecture enables ample space for graft material and its bulletednose and single-instrument inserter/ expander are designed to streamline insertion. FLXfit15 is offered in two lengths—32mm and 40mm, and in

Market watch challenges. These systems typically require a neuromonitoring specialist to interpret the signals and guide the surgeon.

SENTIO MMG consists of a touchscreen tablet, control unit, probes, heights from 8–13mm to accommodate and smart sensors which can be set up diversity in anatomical need. by surgical personnel with a minimal “The FLXfit15 interbody device offers footprint in the operating room. With the surface area contact and lordosis the launch of SENTIO MMG, DePuy often desired in an anterior lumbar Synthes is enabling surgeons to assess interbody fusion (ALIF) procedure nerve status in a differentiated way. but obtained with a less complicated It delivers a patented, smart sensor posterior approach. This implant is technology that provides real-time inserted as a PL, deploys as a TL, and feedback directly to the surgeon on nerve expands to gain lordosis of up to 15 location in the form of visual and audible degrees. It saves me time, is less invasive alerts designed to support surgical and offers optimal sagittal balance decision making and potential efficiency correction. In my opinion, it’s the best during surgery. posterior interbody cage on the market,” “The SENTIO MMG System has says Grant Skidmore, neurosurgeon provided me with a reliable technology at Chesapeake Regional Healthcare in to attain nerve mapping during spinal Norfolk, Virginia, USA. fusion procedures. It is a useful means to Jay Bartling, CEO of CoreLink, assess nerve status intraoperatively while comments, “The surgeon and distributor simultaneously making the operating interest in FLXfit15 has far exceeded room workflow more efficient and expectations in a very short period. decreasing costs for the hospital,” says CoreLink is committed to providing Frank LaMarca, a neurological surgeon advanced technology with world class at Jackson, USA. quality.”

Speaking to Spinal News International, “Last year, expandable devices Depuy Synthes emphasised the grew to over 20% of the “specificity and sensitivity” of this overall interbody system, and highlighted the market—expandable potential for SENTIO MMG devices are clearly to aid in surgical navigation here to stay. or to fuse with robotics in CoreLink’s offering the future.

FLXfit15 is a “The addition of great compliment SENTIO MMG to our to our growing enabling technologies portfolio product offering and CoreLink device will provide value to surgeons positions us well to performing spine procedures in meet the increasing needs of surgeons a variety of care settings, including and patients,” adds Derek Kuyper, vice both hospital and outpatient surgery,” president of sales at CoreLink. comments Nadav Tomer, worldwide president, spine, DePuy Synthes. “This DePuy Synthes expands platform underscores our commitment spine portfolio with nerve to digital technologies that advance care assessment platform for patients and we believe by embracing designed to identify and solutions such as SENTIO MMG we can avoid nerves during spine help to reduce variability and inefficiency surgery in spine surgery.”

Johnson & Johnson Medical Devices Companies have announced that DePuy FDA approval granted for Synthes is introducing SENTIO Eden Spine’s Sphynx MMG, a first-of-its-kind digital Eden Spine’s Sphynx plating system mechanomyography platform designed has been granted FDA clearance, the to assess nerve status and identify and company has announced. avoid peripheral nerves during spine Sphynx was designed to complement surgery. SENTIO MMG enables motor the company’s Giza titanium vertebral nerve monitoring for a variety of spine body replacement with rotatable procedures, including non-fusion endplates, introduced in 2012. The procedures such as discectomy, and both Giza is intended to replace and fuse a minimally invasive (MIS) and open spinal collapsed, damaged, or unstable vertebral fusion surgery. SENTIO MMG is being body due to a tumour or a fracture and broadly introduced at the 2018 North provides multiple angulation options by America Spine Society Meeting (NASS; rotating the endplates.

25–29 September, Los Angeles, USA).

Made of titanium, the low-profile The ability for surgeons to improve Sphynx is designed to be implanted how nerves are assessed is an unmet via the antero-lateral approach for the clinical need in spine surgery, states treatment of thoraco-lumbar instabilities. a company press release. Most Indications include spinal fractures, technologies on the market today rely vertebral tumours, secondary instabilities on multiple needle electrodes in the of the thoracic and thoraco-lumbar spine, patient’s arms or legs to locate motor and any other indication requiring an nerves in the cervical and lumbar spine anterior stabilisation low profile. and generate signals. This technology can “The Sphynx is the latest innovation be problematic due to anaesthesia effects, coming from our research and electrical interference, or interpretation development department in Geneva,

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Switzerland,” says Ben Mokhtar, president of Eden Spine Europe, in a prepared statement. “Our goal was to develop a technology that was simple to use, intuitive, and worked with the anatomy. To achieve that goal, we have developed a cutting-edge integrated locking system, minimised the thickness of the implant in an effort to respect the surrounding tissues, and maximised the range of pre-curved plates, to provide optimal adaptation to patient’s anatomy.”

The Sphynx was granted CE Mark approval in 2016.

ImmersiveTouch launches the first virtual reality integrated suite for surgical planning

ImmersiveTouch announced the launch of ImmersiveView, the only suite of integrated virtual reality real-time solutions for personalised surgical planning, patient engagement, and surgical training using patented haptic technology. ImmersiveView was launched at the North American Spine Society 2018 meeting (NASS; 26–29 September, Los Angeles, USA).

According to a company press release, ImmersiveView is designed to optimise outcomes and save costs, decreasing time in the operating room and improving pre-operative planning and patient satisfaction.

The ImmersiveView suite transforms existing patient computed tomography (CT) and magnetic resonance (MR) images into accurate, fully realised, highresolution virtual reality models that the physician can manipulate and explore from any angle. ImmersiveTouch claim that this enables a level of interaction not previously possible.

Advances in imaging in the last 15 years have led to three-dimensional recreations of anatomy, but they could be viewed on a two dimensional display, limiting the availability to fully interact with the model and assess the patient’s anatomy with full accuracy. ImmersiveView provides 3D visualisation of medical imaging in a virtual reality 3D display.

“Even though we could see patient anatomy in 3D, we could never interact with it because it was trapped in a 2D surface. ImmersiveView allows us to cross that glass barrier to the other side, into a different universe where we can immerse ourselves and interact with the anatomy from all angles using depth perception and even haptics to understand how it feels,” says Pravin K Patel, chief of paediatric plastic and craniofacial surgery at the University of Illinois Health and Medical Science Center, and Chicago Shriners Hospitals for Children

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Product News (Chicago, USA). “It helps our patients and family better understand what the surgeon sees and makes it real for them.”

ImmersiveView is highly intuitive, allowing the physician to grab, turn, expand and explore the VR model of the patient to evaluate procedural options and plan the surgery, Immersive Touch state. The left- or right-handed user can use one button to: measure; draw; cut; overlay and move a 2D scan of the patient anywhere in the image; better visualise specific parts of the anatomy by enabling transparency of tissues, such as bones, organs or blood vessels; and take a picture and save it to the computer for future reference.

Another suite offering provides realistic virtual reality surgical simulation using patented tactile (haptic) feedback.

Surgical residents can familiarise themselves with the exact size, feel, and internal workings of typical patients for specific surgeries and train as many

times as needed to feel comfortable. The training system is fully customisable to all devices.

ImmersiveView is HIPAA-compliant, portable and fully compatible with all Patient Archiving and Communication and Digital Imaging and Communications in Medicine systems.

It can be used with any VR headset and system. Teams can participate in surgical planning by viewing the image the user is experiencing in VR on a display screen in person or via video conference.

According to ImmersiveTouch, the ImmersiveView suite is more costeffective and efficient than 3D printing.

Medtronic launches the Infinity OCT spinal system

Medtronic has announced the US launch of the Infinity Occipitocervical-Upper Thoracic (OCT) System designed to simplify posterior cervical spine surgery.

A company press release describes the

Infinity Occipitocervical-Upper Thoracic (OCT) System

Infinity OCT System as a procedural solution that integrates navigation and biologics with Medtronic’s existing devices and instrumentation for fusion procedure workflows for the upper back and neck. The announcement was made during the 2018 North American Spine Society annual meeting (26–29 September, Los Angeles, USA).

The Infinity OCT System is used to immobilise and stabilise the spine while it fuses. The system features several innovative components—including a multi-axial screw with 60 degrees of angulation in any direction, a set screw (locking cap) with a quick-start thread to minimise cross threading, 3mm and 5.5mm diameter screws for expanded patient demographics and

clinical applications. The system has a full spectrum of implant materials and sizes.

“Some of our posterior cervical patients arrive in critical condition and their lives depend on our surgical skills and the performance of the tools we use to treat them,” says Greg Trost, neurosurgeon at the University of Wisconsin School of Medicine and Public Health (Madison, USA). “With Infinity, I can focus on delivering the best patient care during complex procedures knowing that every component was precisely-designed with modularity and versatility in mind. And an integrated procedural solution with Stealth navigation and Infinity was gamechanging as a 3D-view of the anatomy allows me the precision to place pedicle screws with confidence and accuracy.”

The Infinity OCT is indicated for certain conditions, including degenerative disc disease, instability or deformity, tumours, and traumatic spinal fractures or traumatic dislocations. Spine trauma can sometimes result in a spinal cord injury. According to the National Spinal Cord Injury Statistical Center, the 2016 annual incidence of spinal cord injuries in the USA was approximately 54 cases per million people, or about 17,000 cases per year.

Calendar of events 17–19 November

6–7 December

2019

Jeddah, Saudi Arabia

Dubai, United Arab Emirates

Global Neurosurgery 2019: A practical Symposium

W www.saudispine.org

W www.spine.org/education

New York, USA

26–27 November

6–8 December

2nd Saudi Spine Society Annual Meeting

3rd International Conference on Spine and Spinal Disorders Dubai, United Arab Emirates

18–19 January

Emirates Neurosurgery Annual Conference

W www.cevent.com

26–28 March

13th German Spine Congress of the DWG

2nd Combined Meeting with NASS, SOSSOP, APSS, OASAC-SAARC and POS

Wiesbaden, Germany W www.dwg.com

W www.spine.alliedacademies.com

Lahore, Pakistan

6–8 December

3–5 December

W www.spine.org

ArabSpine Module 1 and 3

Cervical Spine Research Society 46th Annual Meeting

Dubai, United Arab Emirates

Scottsdale, USA

W www.arabspinediploma.org

W www.csrs.org

5 December

13–15 December

Scottsdale, USA

New York, USA

NSpine 2019

W www.csrs.org

W www.cevent.com

London, UK

Cervical Spine Research Society (CSRS) 23rd Instructional Course

3–5 April

International Society for the Advancement of Spine Surgery (ISASS) 19th Annual Conference Anaheim, USA

12th New York City MIS, Robotics & 3D Navigation Symposium: Case Based and Hands-On

W www.isass.org

1–5 July

W www.nspine.com

Issue

March

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Biss2018SpinalNews02.qxp_Mise en page 1 16/10/18 15:33 Page1

XXV th Brussels International Spine Symposium

Disc Herniation Back to Basics CONTROVERSIES IN ETHIOPATHOGENESIS, MANAGEMENT AND COSTS

FACULTY Jean-Jacques Abitbol (San Diego) Max Aebi (Bern) Maryem Aguirre (Exeter) Mark Arts (The Hague) Richard Assaker (Lille) Ray Baker (Kirkland) Michel Benoist (Paris) Scott Blumenthal (Dallas) Manu Capoor (New York) Christine Cedraschi (Geneva) Christopher Colloca (Phœnix) Marc Dubois (Louvain)

Robert Dunn (Cape Town) Alistair Gibson (Edinburgh) Richard Guyer (Dallas) Christoph Hofstetter (Seattle) Nachson Knoller (Tel Aviv) Claudio Lamartina (Milano) Jean-Charles Le Huec (Bordeaux) Isador Lieberman (Dallas) Carlotta Martini (Milan) Michael Mayer (Munich) Eric Muehlbauer (Chicago

Margareta Nordin (New York) Pierce Nunley (Schreveport) Luiz Pimenta (Sao Paulo) Dan Resnick (Madison) Sally Roberts (Oswestry) Bjorn Rydevik (Goteborg) Dino Samartzis (Chicago) Francis Smith (Aberdeen) Francisco Vilarejo (Madrid) Brad Weiner (Houston) Hans-Joachim Wilke (Ulm) David Wong (Denver)

November 16 & 17, 2018 • BRUSSELS - BELGIUM