Comparing Two Bioactive Bone Substitutes for Fusion After Anterior Lumbar Spine Surgery in Adults with Disc Degeneration

What this Trial Is About

Disc degeneration causes worsening damage to the intervertebral discs, leading to significant low back pain and reduced mobility that impacts daily life. This condition is often related to aging and worsened by injuries, lifestyle, and genetics. Surgery involving spinal fusion with an interbody implant and bone graft is a common treatment for advanced cases. This research compares a new bioactive bone substitute, based on osteo-immunology technology MagnetOs, Kuros, to traditional bone grafts and other substitutes to evaluate its effects on bone fusion and functional recovery in adults with degenerative lumbar disc disease. Participants will undergo anterior lumbar interbody fusion surgery using either the new bone substitute Magnetos Putty, Kuros or a conventional bone substitute GlassBone Putty, Noraker. The study randomly assigns 100 adult patients to one of these two groups. The surgical procedure is standard except for the bone substitute used. The study includes visits before surgery, on surgery day, and follow-ups at 3 and 12 months post-surgery, with imaging and assessments to monitor fusion progress and recovery. During the study, participants will have health questionnaires, pain and disability evaluations using the Visual Analog Scale and Oswestry Disability Index, and imaging tests including CT scans and X-rays. Researchers will collect data on pain levels, functional ability, medication use, return to work, and any reoperations or hospitalizations. The main outcome is the change in disability score from before surgery to one year after. Safety and functional improvements will be closely monitored throughout the year-long follow-up.

Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults