20 innovations in spine to know | 2020

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The spine field is rapidly changing. Innovation in spinal surgery techniques, material and patient decision making have led to better outcomes. However, the next wave of disruptive technologies will need to provide clinical significance as well as cost-effectiveness.

Navigation and image guidance. Image guidance and navigation technologies are disrupting the traditional method of performing spine surgery for more precise procedures using less radiation. The FDA approved Joimax's Intracs system for electromagnetic navigation tracking and control during spine surgery. Surgeons can use the technology to perform procedures with minimal X-ray control and the system can flatten the learning curve for endoscopic procedures.

7D Surgical also launched a radiation-free machine vision-image-guided surgery system in the U.S. The system is designed to replace standard fluoroscopy and uses visible light to register spinal segments in seconds. Finally, Alum Biosciences is also studying the use of a nerve imaging drug during spine surgery. The company's ALM-488 peptide-dye conjugate is designed for the fluorescent highlighting of nerves during head and neck procedures.

Robotics. Medtronic leads the spinal robotics market with the Mazor X Stealth Edition technology, which was used at more than 50 U.S. hospitals for 1,000-plus procedures in its first year. The robotic technology includes analytical tools, precision guidance, optical tracking and intraoperative verification and connectivity technologies. Globus Medical also has a robotic spinal system on the market, Excelsius GPS, and Zimmer Biomet has Rosa Spine. NuVasive has been working on spinal robotic technology called The Pulse, which is an open imaging platform with integrated Siemens 3D mobile C-arm. However, the release of Pulse was delayed during the pandemic, CEO Chris Barry said during the company's second quarter earnings call in August, but robotics remains a key part NuVasive's strategy.

"The future for robotics is bright. In addition to trajectory guidance to place hardware and perform complex preoperative planning procedures, robots are soon going to be able to have greater autonomy in the OR, I hope," said Kornelis Poelstra, MD, PhD, of The Robotic Spine Institute of Silicon Valley in Los Gatos, Calif. "We must discuss these advances together with regulatory bodies such as the FDA, but this autonomy will not be far off. Robotic systems should be able to nearly autonomously place hardware, further reducing outliers and human error, help us with discectomy procedures and end plate preparation in a more predictable form as well as with decompression surgery or the spinal canal. Utilizing advanced learning, I am confident that we can start manipulating muscle and fascia and have robotic assistance soon that will help us open and close surgical approaches."

Cervical disc replacement. The cervical artificial disc replacement procedure has evolved over the past two decades into a sleek surgery that shows comparable, if not better, outcomes to spinal fusions. The Prestige LP, M6 and Prodisc-C are among the most common cervical discs and they have long-term data showing their efficacy. Todd Lanman, MD, a spine surgeon in Beverly Hills, Calif., said surgeons are beginning to use artificial disc replacements for more procedures and he sees them becoming part of his revision strategy in the future.

"I believe fusion will be considered archaic, particularly cervical, because the data is so clear that ADR is superior to fusion in almost every outcome measure," said Dr. Lanman. "Over a 10-year follow-up period re-surgical rates are half as much, so you're going to see new artificial discs created with even better designs and functionality, and surgeons are going to more rapidly move toward artificial discs. Many surgeons, particularly on the East Coast, still fuse a lot of patients. I think more disc replacements are done on the West Coast with people living more active lifestyles in a better climate."

The M6-C disc has differentiated itself with a viscoelastic insert mimicking the normal disc, which could improve the biomechanics of the replacement. "As opposed to fusion where the placement is not pivotal as long as you get bone to heal, in artificial discs the placement has to be close to perfect because imperfections can lead to dysfunction of the spine joints leading to pain and early arthritis," said Fabien Bitan, MD, of Atlantic Spine Center in Edison, N.J.

Lumbar disc replacement. Lumbar disc replacements present different challenges than cervical disc replacements, but a 2018 study in Global Spine Journal suggests they can be effective. In a meta-analysis of four studies comparing lumbar disc replacement to fusion, researchers found patients who underwent disc replacements reported lower disability, significantly lower reoperation rates and higher patient satisfaction than fusion. Insurance companies are beginning to take notice of the results and in some cases covering the procedure. In April, the FDA approved Centinel Spine's prodisc L lumbar total disc replacement device for two-level indications. The disc includes two cobalt chrome alloy endplates and an ultra-high molecular weight polyethylene inlay.

Endoscopic spine surgery. The endoscopic spine technique has been evolving for nearly three decades, but remains rare in the U.S. It is a more technically challenging procedure than other techniques, but it has been associated with good outcomes. Raymond Gardocki, MD, of Memphis, Tenn.-based Campbell Clinic Orthopedics, sees endoscopic surgery as having huge potential in the future.

"It currently is a very small part of the market, but it has the greatest benefit and it's applicable to the largest number of patients," said Dr. Gardocki. "We have technologies yet to be developed in endoscopic surgery that are going to allow us to do lumbar and cervical fusions outpatient in addition to the discectomies and decompressions we can already do. Instrumentation and expandable cages — things that can be applied through a very small portal and expanded — are yet to be developed and I think that's where you're going to see everyday degenerative spine treatment change."

There is also emerging literature on endoscopic assisted lumbar fusion. "Some aspects of spine surgery are currently performed without the benefit of direct visualization such as pedicle cannulation and endplate preparation," said Kris Radcliff, MD, of Rothman Institute in Philadelphia. "Some surgeons have been able to utilize endoscopic guidance to facilitate those aspects of surgery. I believe that endoscopic assisted lumbar fusion techniques may be the first exposure of many surgeons to endoscopic spine surgery, as the indications are identical to current spine fusion indications."

Patient positioning. The art of patient positioning has traditionally been overlooked in the spine space and is an area ripe for innovation. In the typical spine case, surgical teams waste invaluable OR time positioning patients with a combination of pillows, towels, foams, sticky rolls, IV bags, arm pegs and tape, which creates an inefficient operative setup. It also makes for inconsistent operative access and a surface that isn't optimized for patient safety.

Bone Foam developed the Nextend Positioning System to simplify the complex positioning methods of anterior cervical cases. The technology optimizes cervical spine positioning while providing a safe and stable operative surface. The system contains a single-use biocompatible padding and straps that comfortably position the extremities and depresses the shoulder girdle to enhance visibility of the lower cervical spine during imaging. Nextend can help surgeons achieve more consistent and repeatable positioning while eliminating inefficiencies and complex tape configurations.

Stem cells. There are many differing opinions on stem cell treatment in spine surgery, with the most pervasive being cautious optimism. No stem cell treatment yet has strong clinical data to prove effectiveness, but the basic science shows promise. "I believe the use of stem-cells in the treatment of degenerative spine conditions has great potential," said Scott Middlebrooks, MD, of Regsurgens Orthopaedics in Atlanta. "Use in augmenting spinal fusion has been shown to be effective. The use in the regeneration of the degenerated intervertebral disc is not as clear. Preliminary studies have shown them to be generally safe. Clear evidence of efficacy and specific indications for use are the primary limitations currently. I am hopeful that with the progression of the current research we will have more evidence to allow practitioners to be confident in the use of stem cell-based therapies to improve the lives of our patients suffering from degenerative spinal conditions."

SI joint. The SI joint has been a tricky area for spine surgeons and pain management specialists to treat effectively, but several recent innovations could make that easier. Inspired Spine developed the Trident Sacroiliac Joint Fusion System with one main screw and two side screws for single procedure that takes around 15 minutes. The procedure was developed by surgeons, but doesn't currently have FDA clearance.

SI-BONE, which has been in the SI joint space for more than a decade, is transitioning now into a comprehensive sacropelvic company. Known for its iFuse Implant System, SI-BONE is working with 22 academic institutions to adopt SI joint treatment for deformity applications and expanded into the trauma market with fractures involving the SI joint.

3D printing. Three-dimensional printing technology has many uses in the spine space. In 2019, New York City-based Hospital for Special Surgery formed a partnership with LimaCorporate to launch a provider-based additive manufacturing 3D printing facility for custom orthopedic implants. Companies such as RTI Surgical developed the Fortilink Interbody Fusion 3D printed implants for degenerative disc disease treatment and Nexxt Spine expanded its 3D printing capabilities last year, adding two machines from GE Additive.

Nexxt Spine also launched its 3D-printed titanium cage for use in the cervical spine and thoracolumbar spine in March. The device, Matrixx corpectomy system, is designed to replace a disc or damaged vertebral body. Stryker also has a line of 3D-printed spinal implants, including the Tritanium C Anterior Cervical Cage, Capri Cervical 3D Static and Expandable Corpectomy systems and Sahara Lateral 3D Expandable Interbody System.

"Where it can and should shine is potentially having a 3D printer intraoperatively that can construct a custom cage based on intraoperative CT scans or imaging," said Brian Gantwerker, MD, of The Craniospinal Center of Los Angeles in Santa Monica and Encino, Calif.

Customized implants. The trend toward 3D printing ushered in the potential for more customized implants in spine. In February, Medicrea received FDA clearance for the UNiD IB3D Patient-matched interbody cages as part of the UNiD ASI platform technology. It was the first FDA clearance issued for patient-matched implants intended for load-bearing applications in spine surgery. The 3D-printed titanium implants provide customized cage dimensions and endplate morphology. Engineers designed the system's cages to restore proper height and angulation using precise mapping and preoperative surgical planning.

"Beyond the implant, customization is also coming to the way surgeons approach each procedure," said Kee Kim, MD, chief of spinal neurosurgery at UC Davis School of Medicine and co-director of the UC Davis Spine Center in Sacramento, Calif. "Individual deformity correction will be customized so we do not, for example, end up fusing all patients from T4 to pelvis."

OLIF. The oblique lateral interbody fusion is an innovative spine surgery approach that allows surgeons to achieve the same outcomes as open procedures with less tissue disruption. Camber Spine's SPIRA-O, which has an arch design for the oblique position, can be used in the OLIF procedure in which patients are placed in the lateral decubitus position so gravity can drain away the peritoneal contents. "When you approach the anterior spine obliquely, you're no longer retracting the lumbar plexus in the way that we do when we do transpsoas surgery," said John Williams, MD, of SpineONE in Fort Wayne, Ind. "You essentially eliminate plexus injury, limb numbness, quadriceps weakness and other issues we have with transpsoas surgery."

The oblique lateral lumbar interbody fusion procedure from Inspired Spine has also been performed in more than 1,000 cases in the U.S. The procedure is intended for patients with degenerative disc disease, herniated disc, scoliosis and spinal stenosis. The procedure is designed to heighten the disc and limit disc movement while preserving muscles and the adjacent tissue.

Augmented reality. Augmedics made a splash in the spine field in June when three neurosurgeons at Johns Hopkins Hospital in Baltimore performed the first spinal fusion on a living patient using its augmented reality system. The company's FDA-cleared Xvision spine system enables surgeons to visualize the 3D spinal anatomy intraoperatively so they can navigate instruments and implants while looking at the patient instead of a remote screen.

Timothy Witham, MD, director of the Johns Hopkins neurosurgery spinal fusion laboratory, performed the first procedure alongside Daniel Sciubba, MD, director of spinal tumor and spine deformity at Johns Hopkins. Camilo Molina, MD, also assisted. "For the surgeon, Augmedics provides increased visualization of the entire spine and tumor anatomy, allowing complete tumor resection to be accomplished safely," said Dr. Sciubba. "The technology also allows a more efficient surgery and saves time in the operating room. Finally, augmented reality also limits the use of radiation to the patient, to the surgeon, and to the operating room staff. In short, it allows for the most effective treatment for the removal of spine tumors I have experienced in the last 20 years of doing such surgeries."

Artificial intelligence. Artificial intelligence has great potential in healthcare and can be particularly beneficial in spine. AI tools can help with surgical decision making and reading imaging studies. The technology won't replace surgeons, but it can enhance the surgeon's data processing capabilities to develop the best treatment process for patients.

"In spine fracture management, a main focus for us is predicting which patients will fracture or not," Joseph Schwab, MD, chief of orthopedic spine surgery at Boston-based Massachusetts General Hospital said. "One of the biggest trends in the field right now is using machine learning or artificial intelligence to predict fractures. This trend will allow for prediction models that are currently relatively static to be replaced with AI to offer a more personalized and accurate description of where fractures will happen on a patient."

Regenerative medicine. Regenerative medicine is still in its infancy in the spine field as companies innovate alongside surgeons engaged in basic science and clinical trials to prove effectiveness. One treatment is Discseel in which the surgeon injects fibrin into a torn disc to seal tears within the annulus fibrosus. The procedure is an off-label use of an FDA-approved corticosteroid. Kevin Pauza, MD, an interventional spine specialist and founding partner of Texas Spine and Joint Hospital in Tyler is conducting clinical research on the procedure and examining whether the treatment can eliminate recurrent disc herniation and degeneration.

"Payers increasingly want regenerative medicine. With regard to the Discseel procedure, their interest may be motivated by cost-savings, efficacy or the reliability of large-scale budgetary predictions," said Dr. Pauza. "In my experience, payers have been pleased that 1 to 4-level fusions can be routinely replaced by the outpatient Discseel procedure in ASCs. I believe other regenerative medicine treatments will be embraced after they also provide positive independent data. There's no independent study of any other biologic treatment on the horizon, but we're waiting with optimism."

Spinal cord injury treatment. One of the big innovations in the traumatic spine injury arena is spinal cord stimulation to treat quadriplegic patients. "There's a lot of smart people out there and the best thing to do is to collaborate," said Jeffrey Wang, MD, co-director of the USC Spine Center at Keck Medicine of USC in Los Angeles. "Spine surgeons are somewhat intelligent but there are a lot of basic scientists out there in other areas that may have therapeutics that could be applied to the spine. I think we need to collaborate with scientists in other specialties to come up with the best techniques."

There have also been several clinical trials in the past decade showing the benefit of stem cell treatment for patients with spinal cord injury. Neuromodulation and advances with electrical stimulation and computer programs are also giving patients the ability to perform functional actions by bypassing the spinal cord and using a direct brain to peripheral nerve stimulation or interference, said James Harrop, MD, chief of the division of spine and peripheral nerve surgery at Jefferson University Hospitals in Philadelphia.

Awake spinal fusion. In some pockets of the U.S., surgeons are beginning to perform awake spinal fusions. Alok Sharan, MD, director of spine and orthopedics at NJ Spine and Wellness in Freehold, was among the early adopters of the procedure. He began performing awake spinal fusions for patients undergoing minimally invasive transforaminal lumbar interbody fusion procedures in 2017, administering spinal and regional anesthetic while keeping the patients awake. The patients typically listen to music over headphones during the procedure and many return home within 24 hours of surgery.

As care migrates more towards the ambulatory setting, he sees this as becoming a more realistic option for patients. "I'm confident in the ability of awake spine surgery to deliver high-value more efficient care," he said.

Minimally invasive tubular retractors. The development of minimally invasive tubular retractor systems transformed spine surgery by allowing surgeons to quickly accomplish the procedure with minimal tissue disruption. John Wilson, MD, vice chair of the department of neurosurgery and executive director of the neuroscience service line at Wake Forest Baptist Health in Winston-Salem, N.C., said, "In the circumstance of incidental durotomy, cerebrospinal fluid leak is virtually unheard of. As experience with this minimally invasive technique has increased, the types of cases that can be done have expanded beyond decompressive procedures to include fusions, intra and extra dural tumors, and at any level in the spine."

Pediatric scoliosis treatment. In pediatric scoliosis treatment, growth modulation with vertebral body tethering has emerged as an option for some children to achieve better outcomes, but that's just scratching the surface, said Amer Samdani, MD, chief of surgery for Shriners Hospital for Children – Philadelphia. "I feel in pediatric spine, growth modulation will become a more utilized technique," he said.

New techniques also include anterior vertebral body tethering, a non-fusion technique for scoliosis correction. According to a post from Cleveland Clinic, the procedure can be performed on pediatric patients with growth remaining and idiopathic curves between 35 degrees and 70 degrees. Surgeons perform video-assisted thoracoscopy through four to five portals in the hemithorax and use fluoroscopy as well as camera visualization to place anterior screws in the vertebral bodies along with a staple at each level. The surgeons connect the instrumentation with a tether device for the correction.

Multimodal pain management. Over the past decade, an addition to the multimodal pain management protocol for spine surgery patients helps them mobilize quicker after surgery and supports the transition to outpatient spine ASCs. "The use of multimodal approaches such as pre- and postoperative gabapentin, celecoxib and intraoperative Ketamine have helped but there is still room for improvement," said Fred Naraghi, MD, of Comprehensive Spine Center in Klamath Falls, Ore. "An ideal pain medication would be non-opioid, non-habit forming with minimal side effects and equivalent potency for pain relief."

Anther tool surgeons can use is a bupivacaine liposome injection, a local anesthetic that can reduce pain associated with the procedure for the immediate postoperative period. As a result, patients are able to stand up and walk sooner after surgery and return home with minimal pain. The injection also helps patients use fewer or no opioids during the recovery period.

Telehealth. The pandemic forced many specialists to postpone elective procedures temporarily in early 2020 and turn to telehealth for office visits. Patients are now comfortable with the technology and expect spine surgeons to be available for consultation virtually. Surgeons are also adapting to the technology change. Alexander Vaccaro, MD, PhD, president of Rothman Orthopaedics in Philadelphia, believes he could diagnose patients appropriately through telemedicine 80 percent of the time.

"We can do interviews with patients using telehealth, so you call up front for an appointment and I could sit down and I could talk to you," he said. "That's how spine surgery will change, will be much more efficient, be less likely to get burnt out, be more resilient because we're doing things we really love to do."

Physical therapy is another area that is going virtual amid the pandemic. James Lynch, MD, founder of SpineNevada in Reno, has been working on tele-physical therapy for several years. "The COVID-19 crisis has really fast-forwarded the technology, and I think telemedicine will continue to be huge. What would traditionally take years to change the mindset of providers, patients and the community occurred within a one-month period, and now it's standard accepted practice," he said.

Multimodal pain management. Over the past decade, an addition to the multimodal pain management protocol for spine surgery patients helps them mobilize quicker after surgery and supports the transition to outpatient spine ASCs. "The use of multimodal approaches such as pre- and postoperative gabapentin, celecoxib and intraoperative Ketamine have helped but there is still room for improvement," said Fred Naraghi, MD, of Comprehensive Spine Center in Klamath Falls, Ore. "An ideal pain medication would be non-opioid, non-habit forming with minimal side effects and equivalent potency for pain relief."

Another tool surgeons can use is a bupivacaine liposome injection, a local anesthetic that can reduce pain associated with the procedure for the immediate postoperative period. As a result, patients are able to stand up and walk sooner after surgery and return home with minimal pain. The injection also helps patients use fewer or no opioids during the recovery period.

This list is sponsored by Bone Foam.

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