3Spine has announced completion of the first series of US surgeries in the BalancedBack total joint replacement investigational device exemption (IDE) pivotal clinical trial.
All patients enrolled in the IDE trial will receive the company’s MOTUS device and will be propensity matched against patients prospectively enrolled in 3Spine’s real-world evidence (RWE) fusion study, using an adaptive statistical design. 3Spine’s RWE study has been enrolling in the US since May 2021.
Benjamin Geddes performed the surgeries at the Center for Sports Medicine and Orthopaedics (Chattanooga, USA), assisted by Alex Sielatycki, of the Steamboat Orthopaedic and Spine Institute and UC Health Yampa Valley Medical Center (Steamboat Springs, USA).
“Alex and I are humbled to have the honour of performing the first lumbar total joint replacements in the US,” said Geddes. “The procedures went very well. Each patient was up and walking within two hours after surgery, using the early mobilisation protocols for hip and knee arthroplasty patients. This is an encouraging start and we look forward to continuing enrolment.”
3Spine’s MOTUS device, the implant used in the BalancedBack total joint replacement procedure, is a ‘first of kind’ technology replacing the function of the disc and facet joints through a posterior approach. The procedure is intended to broadly address leg pain, back pain, and spinal instability, while correcting posture and restoring freedom of movement through reconstruction of the functional spinal unit.
3Spine is seeking single-level indications from L1-S1 in patients suffering from lumbar degeneration with or without foraminal or recess spinal stenosis with no more than a grade one spondylolisthesis at the involved level.
Jeff Goldstein, national principal investigator (PI) for the IDE trial, commented: “On behalf of our study PIs around the country, I would like to congratulate Benjamin Geddes on being the first site to complete enrolment of the RWE study, making him eligible to begin enrolment of the IDE.”
Dom Coric, MD, national PI for the RWE study, added: “This is historic work. Our strategy to first collect real-world evidence on a variety of posterior lumbar fusions is working well, providing an important baseline at each site and allowing for a staged start to the IDE across centres. I echo Jeff in congratulating Alex and Ben on their achievement.”