The spine field is rapidly changing. Innovation in spinal surgery techniques, material, manufacturing and patient triage, have led to better patient outcomes. However, the next wave of disruptive technologies will need to prove clinical significance as well as cost effectiveness.
Orthofix is a global medical device company focused on providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. The company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation and we collaborate on research with leading clinical organizations including Musculoskeletal Transplant Foundation, Orthopedic Research and Education Foundation and Texas Scottish Rite Hospital for Children.
Here are 20 key trends in spine technology available today as well as innovation on the horizon.
Robotic technology. Minimally invasive robotic technology for spine surgeries is becoming common in operating rooms across the country. There are three major spinal robots on the market now, and a fourth is expected in September. Each system is different, but all aim to improve precision, surgical accuracy, screw placement and outcomes. Surgeons can pre-plan their procedures based on CT scans of the patient's anatomy and execute with the robotic technology. Robotic technology also has the potential to reduce surgical time, radiation exposure and length of stay, thereby reducing the cost of care. The spine robotics market hit $75 million in 2017 and is expected to grow to $320 million by the end of 2026, according to Transparency Market Research.
Navigation. Spinal navigation technology translates image guidance to an open navigation platform for more accurate pedicle screw placement. The navigation platforms can also help plan incisions and trajectory for any instruments, safe implant placement and reduce X-ray exposure. In 2016, the first Spinal Navigation, Emerging Technologies and Systems Integration Meeting occurred for stakeholders to discuss key trends in the market. Charles Fisher, MD, and his team reported a cost-effectiveness ratio for CT based navigation systems at $15,962 for institutions with 254 spinal instrumentation procedures per year. Some surgeons, like New York-based Roger Hartl, MD, have incorporated total navigation into their practices.
3D printing. Additive manufacturing, or 3D printing, is an emerging field for orthopedic and spine devices. Earlier this year, Hospital for Special Surgery in New York City entered into a partnership to develop the first provider-based additive manufacturing 3D printing facility for custom orthopedic implants. UC San Diego School of Medicine and Institute of Engineering has printed 3D spinal cords and implanted them in rats with severe spinal cord injuries. Mayo Clinic in Rochester, Minn., has also taken advantage of 3D printed spine models for training purposes. Multiple device companies have released 3D printed spinal implants, made from both titanium and PEEK. The technology could provide a more precise implant for each individual patient's anatomy.
Regenerative Technologies. Development of stem cell treatments for spinal disorders is in its early stages. In a literature review, Mayo Clinic researchers examined studies about biologics and disc regeneration with at least 11 studies associating stem cell transplantation with significantly lower disc degeneration grades, compared to a control group, and nine studies reporting type II collagen expression. With respect to bone repair, innovation continues to look at addressing the properties important for healing during fusion procedures. Technologies like Trinity ELITE™ from Orthofix, a third-generation allograft with viable cells, are designed to promote bone formation after spinal surgery. Orthofix represents the allograft, which is processed through MTF Biologics in a manner which preserves the viable cells inherent within the bony matrix. Post-operative, bone growth stimulators are another technology available to aid in healing a spinal fusion. The Orthofix Spinal Fusion Therapy devices, SpinalStim™ and CervicalStim™, promote healing in spinal fusions by stimulating the bone’s natural healing process via pulsed electromagnetic field (PEMF) technology.
Disc regeneration. Disc regeneration technology is in the early stages of development and testing, but has the potential to revolutionize spine care. Dr. Hartl believes annular repair is the most significant innovation in spinal biologics today. His team has made improvements in developing compounds that seal annular defects from disc herniation quickly and effectively. Other clinicians, engineers and researchers are working on total biological disc replacements that could disrupt the spine field and reduce the need for more invasive procedures.
Nanotechnology. In 2014, the FDA issued its first clearance for nanotechnology in spine. The implant's surface technology was developed with increased textures at the nano level. The interbody fusion devices, made from titanium, generate the osteogenic and angiogenic responses to drive bone growth in spinal fusions. About four years later, the FDA cleared its first nanotechnology spinal implant made with polyetheretherketone, with nanotexturing below 100 nanometers to promote bone growth and fusion. In March 2019, a literature review published in World Neurosurgery examined nanotechnology in the spine field and concluded it was promising with several applications, but it's still in the early stages. "Eventually, we may see the implementation of nanotechnology as an alternative to existing treatment options," concluded the study authors.
Titanium. Titanium spinal implants are re-emerging as a desirable implant material that promotes positive patient outcomes. In the 1990s, titanium cages were associated with subsidence due to the cage design. The threaded cylindrical cages had the potential to damage vertebral endplates during insertion. However, an updated design and new visualization technology make surface-enhanced titanium implants attractive because they promote bone growth. "The biggest innovations in implant material would certainly be the low modulus titanium," said Todd Lansford, MD, of South Carolina Sports Medicine & Orthopaedic Center during an interview with Becker's. "For so long we have avoided metal for implants due to subsidence risk. Companies now have developed titanium/tritanium with lower modulus of elasticity. This allows for all the benefits of titanium — fusion potential, in growth and bacterial resistance — without the risks."
Enhanced Polyetheretherketone. PEEK has a modulus of elasticity similar to bone and has become the implant material of choice for many spine surgeons. PEEK's radiolucency allows for radiographic visualization of the surgical site to determine whether fusion was successful. While PEEK is the predominant standard of care for interbody devices, there is a drive towards materials that allow for improved incorporation at the bone interface. Several spine device companies manufacture with a PEEK material that is titanium-coated for this reason. Orthofix has taken a different approach to sprayed titanium PEEK by instead 3D printing the titanium endplates and molding them into the PEEK interbody. This approach provides the key benefits offered by both the PEEK and titanium materials into one interbody device. The benefits include allowing the patient's bone growth onto the 3D porous titanium endplates while maintaining the ideal imaging properties of the PEEK core. Examples of this technology are the Forza® PTC (PEEK-Titanium Composite) PLIF and TLIF interbody devices.
Liposomal bupivacaine injection. 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 bupivacaine liposome injection is 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. Total knee replacement patients have also used the injection for pain, and data shows better outcomes for patients who receive liposomal bupivacaine injections, including 78 percent lower opioid consumption and 13.6 percent less pain in cumulative pain scores.
Vertebral augmentation. Patients with spinal fractures may benefit from vertebral augmentation, including vertebroplasty and kyphoplasty. In 2013, the National Institute for Health and Care Excellence stated vertebral augmentation had enough associated evidence to be considered effective for patients with painful osteoporotic vertebral compression fractures. Studies also show patients who undergo vertebroplasty or kyphoplasty have up to 43 percent lower mortality risk five years after treatment than patients who undergo non-surgical management. Then in 2018, the International Society for the Advancement of Spine Surgery released a policy statement for coverage. There are several systems available with FDA clearance for vertebral augmentation and the technology continues to evolve.
Endoscopic spine surgery. Endoscopic spine surgery has been available since the 1980s, however, the technique has not been widely adopted in the United States. Endoscopic procedures can be performed under local anesthetic and sedation in the outpatient setting, but there is a steep learning curve associated with the technology. Surgeons in Europe and Asia have adopted endoscopic techniques for spinal surgery at a higher rate than in the U.S., and a 2018 article in Asian Spine Journal suggests incorporating robotic technology with endoscopic instrumentation could be the next evolution in expanding the treatment for more complex surgeries including tumor resection and scoliosis correction. "As we move towards a patient-centered and cost-effective model of healthcare, we may see endoscopic spine surgery become increasingly relevant to the future of spine surgical practice with improved patient outcomes and decreased medical costs," the article's authors concluded.
Deformity correction. There is ample room for innovation in the $2.4 billion scoliosis correction market, according to Persistence Market Research. New developments in the field include technology that incorporates lower profile instrumentation, improves accuracy with pedicle screw placement and allows for less invasive procedures. Orthofix launched its Firebird deformity correction system with direct vertebral rotation construct with cobalt chrome rods in 2010 and added the Pedicle Subtraction Osteotomy and Vertebral Column Resection techniques for sagittal deformity over the past decade. For adolescent patients with scoliosis correction, innovation in growing rod technology has made the procedure less intrusive. Magnetic growing rods require just one invasive surgical procedure and then surgeons lengthen the rod magnetically with an external remote.
Spacer systems. Spinal spacer technology has evolved to incorporate many other innovative approaches in spine. The newest Forza® PTC Spacer Interbody System from Orthofix that combines PEEK and titanium materials for its interbody implant. The technology has a 3D printed porous endplate to facilitate bone growth, and a large opening for bone grafting material.
Artificial intelligence. Artificial intelligence and machine learning are making inroads in spine, as exemplified by a discussion at the American Association of Neurological Surgeons Annual Scientific Meeting in April. Researchers presented on an AI-driven model that could improve referrals for degenerative lumbar spine conditions and predict the likelihood of progression to spine surgery. The American Academy of Orthopaedic Surgeons Annual Meeting also included discussions of AI applications in spine to predict spinal fractures. Winston-Salem, N.C.-based Novant Health Orthopedics & Sports Medicine has partnered with companies like Google and Microsoft to adopt an AI platform for optimized care pathways. There are a wide range of possibilities for AI to improve spinal treatment and outcomes in the future.
"The goal is to use data to draw conclusions that contribute to evidence-based medicine and transform care, helping to ensure greater value and better outcomes with reduced overall cost," said Azadeh Farin, MD, a neurosurgeon and spine surgeon at Long Beach (Calif.) Medical Center. "The trend is to use technology to influence physician decision-making, improve clinical outcomes and stabilize institutional finances."
Cervical artificial disc replacement. Short and long term studies compare cervical artificial disc replacement favorably to fusion, and payers have taken notice with expanded coverage. Studies show reoperation rates for one- and two-level surgeries are 14 percent to 17 percent for spinal fusions, compared to 2 percent to 5 percent for total disc replacements. The two-year data on Orthofix's M6-C™ artificial disc shows 91.2 percent of patients who received disc replacement reported improved neck pain, compared to 77.9 percent of patients who underwent fusions. Disc replacement patients had a lower average surgery time at 74.5 minutes, compared to 120.2 minutes for fusion patients, who also reported a seven-times higher rate of postoperative opioid use than disc replacement patients.
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; in July 2018 United Healthcare issued a positive medical policy for lumbar total disc replacement to cover single-level procedures for degenerative disc disease patients.
Sacroiliac joint fusion. Sacroiliac joint dysfunction can cause significant pain, but minimally invasive procedures can help patients experience relief. Technology such as the Orthofix SambaScrew™ System allows surgeons to perform SI joint fixation with 9 mm cannulated screws. According to iData, the U.S. minimally invasive SI fusion market is expected to hit $360 million by 2024 and continue growing. Over the past two years, multiple insurance companies including several Blues plans and government payers have updated coverage policies to include minimally invasive SI joint procedures.
Interlaminar stabilization. In 2018, the North American Spine Society launched coverage policy recommendations for lumbar interspinous devices without fusion and decompression. The procedure is designed for lumbar stenosis patients who do not need a spinal fusion but have failed conservative treatment. During the procedure, surgeons perform a decompression and then insert an interlaminar stabilization device between the adjacent lamina of one or two lumbar motion segments. Studies show six weeks after surgery, 82 percent of interlaminar stabilization patients reported successful clinical outcomes with improved pain and function, compared to 66 percent of fusion patients.
Spinal cord injury. Experimental treatments for spinal cord injuries in the U.S. have demonstrated promising results for improvement in sensory and motor function. Kentucky Spinal Cord Injury Research Center at University of Louisville helped patients regain some motion through an epidural stimulator treatment, which uses an electrical current to stimulate the spinal cord. Researchers from Saint Louis University examined spinal cord stem cells and how neuropathic pain can be switched off in a laboratory. Over the past decade, companies have attempted to develop treatments for spinal cord injury patients, with mixed results. There are currently patients enrolled in a trial of a neuro-spinal scaffold — a biodegradable device implanted after acute spinal cord injuries that supports nerve sprouting.
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