Study of CONDUIT Anterior Lumbar Interbody Fusion Cage System with Supplemental Fixation for Lumbar Degenerative Disc Disease at One or Two Spinal Levels from L2 to S1

What this Trial Is About

Researchers are studying patients with lumbar degenerative disease undergoing anterior lumbar interbody fusion ALIF surgery. This prospective, multi-center study at a national spinal trauma referral center evaluates the CONDUIT174 ALIF Cage System, a 3D printed titanium implant designed to aid spinal fusion. The study compares outcomes in frail and non-frail patients and aims to see if results with CONDUIT are comparable to historical data using SYNFIX Systems. Participants will receive spinal stabilization using the CONDUIT ALIF Cage System with supplemental posterior fixation. This FDA-approved device mimics natural bone structure with porous titanium to support fusion. The study includes a cohort of 35 prospectively enrolled patients using CONDUIT and a historical cohort of 70 patients treated with SYNFIX and posterior fixation. Both groups undergo ALIF surgery at one or two spinal levels between L2 and S1. During the 24-month follow-up, patients will have regular assessments including X-rays or CT scans to check for radiographic fusion and mechanical stability. Researchers will also track patient-reported pain using a visual analogue scale and function using the Oswestry Disability Index and Short Form 12 questionnaires. Outcomes will be monitored to assess fusion success and quality of life changes after surgery.

CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage System in Lumbar Degenerative Disease