Study of the iFuse Bedrock Technique with Posterior Lumbosacral Fusion and Iliac Fixation to Reduce Postoperative Pain and Improve Outcomes

What this Trial Is About

Researchers are evaluating the iFuse Bedrock technique in patients undergoing multilevel posterior lumbosacral fusion to reduce post-operative pain. This multicenter clinical investigation aims to assess how this device-based method may impact lumbar and sacroiliac joint pain up to 12 months after surgery. The study focuses on patients with degenerative sacroiliac joint disease who require fusion procedures involving at least L4, L5, and S1 vertebrae. The treatment involves a multilevel lumbar fusion combined with sacroiliac joint stabilization using the iFuse-3D system following the Bedrock technique. Participants receive open posterior lumbosacral arthrodesis with iliac fixation and at least one iFuse-3D implant inserted unilaterally or bilaterally. The study includes a 12-month follow-up period during which patients are monitored clinically and radiologically. Participants will be followed for a full year after surgery, with lumbar pain assessed using tools like the Oswestry Disability Index, Visual Analog Scale, and SF-12 questionnaire. Sacroiliac joint pain will be evaluated with provocative tests, and a CT scan at 12 months will check for any implant-related issues. Researchers will collect data on pain changes, quality of life, spinal alignment, and any complications or adverse events related to the device.

Evaluation of the IFuse Bedrock Technique in Association with Posterior Lumbosacral Fusion with Iliac Fixation.