3Spine has announced the achievement of completed US clinical trial enrolment, with 151 completed MOTUS lumbar total joint replacement surgeries and 174 real-world posterior lumbar fusions—as of December 2023. The company enrolled a larger fusion cohort in an adaptive statistical design to improve propensity score matching between datasets, as per a press release.
The trials involved patients experiencing chronic leg and back pain ranging in age from 23–79 years across 14 US states. 3Spine plans to seek US Food and Drug Administration (FDA) approval through the premarket approval (PMA) pathway.
“I would like to personally thank my friends and colleagues across the USA who contributed to this important research,” said Jeffrey Goldstein (NYU Langone Health, New York, USA), national principal investigator for the MOTUS investigational device exemption (IDE) study. “Learning a totally new and potentially game-changing spine procedure has been incredibly rewarding, and our own experience here at NYU suggests that we have developed something with remarkable significance.”
3Spine’s MOTUS device is a “first-of-kind” breakthrough medical technology indicated for the biomechanical reconstruction and stabilisation of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1, according to a company press release. MOTUS replaces the function of the disc and facet joints through a posterior approach, where the dual bearings resist rotation and shear—much like the two native facet joints—while carrying compressive axial loads like the disc. The technology is similar to other modern orthopaedic joint replacements, utilising highly cross-linked antioxidant vitamin E polyethylene, compression moulded into a CoCr, titanium plasma sprayed substrate, the release adds.
MOTUS has been in development for over two decades. In 2020, the US FDA designated MOTUS as a Breakthrough Device—a category that identifies and accelerates life-saving treatments for significant disease states affecting the US population. In addition, 3Spine claims that a growing body of evidence suggests that preserving low-back flexibility is far more important than once thought, “even for simple activities like sitting at a desk or comfortably riding in a car”. The FDA’s IDE to study joint reconstruction of the lumbar spine as an alternative to rigid spinal fusion was approved in June 2022.
Pierce Nunley (Specialists Hospital Shreveport, USA), chairman of the American Board of Spine Surgery, stated: “True change only comes along once in a generation. When I first saw the concept, it seemed too simple. But in medicine, simple is best. I believe MOTUS has the potential to fundamentally change spine care.”
