An Open Label, Prospective, Multicenter, Single-Arm, Post-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion
PainTEQ, LLC
Summary
The purpose of this study is to evaluate the real-world performance, safety and efficacy of the TRAQ System.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: To be eligible to participate in this study, a subject must meet all the following criteria, as determined by the Investigator: 1. Age and Body Mass Index (BMI) 1. Adult patients aged ≥ 21 years at screening. 2. BMI ≤ 40. 2. Chronic SIJ Related Pain 1. Has experienced low back and/or buttock pain for at least 6 months that has been inadequately responsive to non surgical management. 2. Has experienced nonradicular pain that is maximal below the L5 vertebrae, localized over the posterior SIJ, and consistent with SIJ pain. 3. Diagnosis of SIJ Dysfunction a…
Interventions
- OtherBone Allograft
The PainTEQ TRAQ™ Posterior SI Joint Implant is processed human bone tissue that has been precision milled from cortical and cancellous bone. The allograft pierces the SI joint cortices and provides a scaffold around which new bone can grow.
Location
- Pain Institute of Southern ArizonaTucson, Arizona