Evaluating the LINQ Procedure Versus Conventional Medical Management for Treating Sacroiliac Joint Dysfunction A Long-Term, Randomized Multicenter Clinical Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the LINQ fusion procedure compared to conventional medical management for treating sacroiliac joint SIJ dysfunction. This is a prospective, multi-center, open-label, randomized clinical study designed to assess treatment options for adults experiencing chronic SIJ-related pain that has not responded well to non-surgical care. Participants will be randomly assigned in a 21 ratio to either receive the LINQ procedure, which involves implanting compatible bone allograft implants to prepare the SIJ for fusion, or to receive standardized, stepwise non-surgical management known as Conventional Medical Management CMM. After six months, those in the CMM group may choose to continue with this care or crossover to receive the LINQ procedure. Study visits include screening, baseline procedure or CMM initiation, and follow-up visits through 24 months. For participants who crossover, additional follow-up occurs through 18 months after the procedure. During the study, participants will have evaluations at multiple time points including 1, 3, 6, 12, 18, and 24 months. Assessments will include pain measurement using a Visual Analog Scale VAS, disability evaluation with the Oswestry Disability Index ODI, quality of life questionnaires, patient global impression of change, medication use, and monitoring of adverse events. The primary outcome is measured at six months by the composite success responder rate. Participants are expected to avoid all forms of nicotine throughout the study and comply with follow-up visits and procedures.

LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction