Study of the Efficacy and Tolerance of the B-Dyn Medical Device Compared to Conventional Bolted Fusion in Degenerative Lumbar Stenosis Treatment Evaluating Postoperative Functional Disability, Mobility Preservation, and Adjacent Syndrome Prevention

What this Trial Is About

Degenerative Lumbar Spinal Stenosis (LSS) is a common condition affecting over 102 million people annually. It involves narrowing of the spinal canal in the lower back, causing pain and leg problems. When symptoms worsen despite medical treatment, surgery is recommended. This study compares the B-Dyn dynamic stabilization device with conventional rigid fusion surgery to see if B-Dyn can maintain function and mobility better after surgery and reduce degeneration of adjacent spine segments. Participants will receive either the B-Dyn device or conventional bolted fusion with or without a cage during surgery under general anesthesia. The B-Dyn device stabilizes the operated area while preserving some mobility, using screws and a movable rod. Conventional fusion connects screws rigidly to stabilize the spine segment. The study lasts 60 months with a 56-month inclusion period to enroll about 216 patients. During the study, participants will have regular assessments including disability questionnaires (Oswestry Disability Index), pain scales, quality of life surveys, anxiety evaluations, X-rays, MRI scans, and walking tests at multiple timepoints up to 60 months after surgery. Researchers will monitor safety, device tolerance, mobility preservation, and complications such as adjacent segment degeneration. The primary outcome is the degree of functional disability related to low back pain at 12 months post-surgery.

Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)