Tennessee-based medical device firm 3Spine has announced that it has completed the enrolment in a clinical trial set to pave the way for regulatory clearance for its alternative to lumbar spinal fusion.
The new study enrolled a larger cohort of fusion patients who experience chronic leg and back pain ranging in age from 23 to 79.
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The trial comes off the back of two other trials consisting of 151 completed lumbar total joint replacement surgeries (NCT05438719) and 174 real-world posterior lumbar fusions (NCT04823858). The new trial is aimed at paving the way for the company’s Motus system through the US Food and Drug Administration (FDA) premarket approval pathway.
The Motus device is indicated for the biomechanical reconstruction and stabilisation of a spinal motion segment following decompression at one lumbar level. Similar to other modern orthopaedic joint replacements, it replaces the function of the disc and facet joints.
The device was given a breakthrough designation by the FDA in 2020, while the FDA’s investigational device exemption was approved in June 2022 to study the joint reconstruction of the lumbar spine as an alternative to rigid spinal fusion.
Principal investigator of the study Jeffrey Goldstein said: “Learning a totally new and potentially game-changing spine procedure has been incredibly rewarding, and our own experience here at New York University suggests that we have developed something with remarkable significance.”
