Evaluating the Safety and Effectiveness of the CORUS-LX System with Pedicle Screw and Rod Fixation in Two-Level Lumbar Fusion for Degenerative Lumbosacral Disc Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a device called CORUS-LX used alongside lumbar interbody fusion surgery for patients with symptomatic degenerative lumbosacral disc disease requiring two-level fusion between L4 and S1. The study compares outcomes between patients receiving standard minimally invasive supplemental posterior fusion and those treated with the CORUS-LX device. The trial aims to determine fusion success, absence of serious device-related events, and avoidance of injections or revision surgery related to back or leg pain. Participants will undergo two-level lumbar interbody fusion surgery at L4-L5 and L5-S1 segments with posterior fusion. One group will receive the CORUS-LX device combined with pedicle screw and rod fixation, while the control group will have standard supplemental posterior fusion with similar fixation. Both groups will have instrumentation placed using navigation technology. After surgery, participants will have follow-up visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months to assess outcomes. During the study, participants will attend these scheduled visits to complete surveys on patient-reported outcomes and undergo standard care procedures. Researchers will collect data from imaging and clinical assessments to measure fusion success and monitor for adverse events. The primary outcomes focus on fusion at treated anatomy and freedom from serious device-related events or injections at 12 months. Additional measures include interbody bone presence, segmental motion, disc height changes, and long-term freedom from injections or revision surgery through 24 months. The study duration extends to 24 months of follow-up after surgery.

Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes