Study of the TRAQ System for Minimally Invasive Sacroiliac Joint Fusion in Adults with Sacroiliac Joint Dysfunction and Pain

What this Trial Is About

This research aims to evaluate the real-world performance, safety, and effectiveness of the TRAQ System for treating adults with sacroiliac joint dysfunction and pain. The study focuses on patients who have experienced chronic low back or buttock pain related to the sacroiliac joint that has not responded well to non-surgical treatments, and have been diagnosed based on specific clinical tests and diagnostic injections. The research is an open-label, prospective, multicenter, single-arm post-market clinical study sponsored by PainTEQ, LLC. Participants will undergo minimally invasive posterior sacroiliac joint fusion using the PainTEQ TRAQ12 implant, which is a processed human bone allograft designed to support new bone growth in the joint area. The implant is placed through a minimally invasive procedure targeting the sacroiliac joint. This study does not include a control group and focuses on evaluating patients receiving this specific treatment. Throughout the study, participants will be regularly assessed with questionnaires and measures including the Visual Analog Scale for pain, Oswestry Disability Index, PROMIS-292, EQ-5D-5L quality of life questionnaire, and other patient-reported outcomes at multiple time points up to 24 months after treatment. Medication use and healthcare resource utilization will also be tracked. The primary outcome will be a combined safety and efficacy measure evaluated at 6 months. Participants are expected to comply with study visits and follow-ups as part of their routine clinical care.

Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion