Multi-Center Registry Study Evaluating Patient Satisfaction With TransLoc 3D SI Joint Fusion System

What this Trial Is About

Researchers are conducting a multi-center registry study to assess patient satisfaction following sacroiliac SI joint fusion using the TransLoc 3D SI Fusion System. This observational study aims to collect real-world data from patients who have undergone this procedure, focusing on their satisfaction with the device approximately one to one and a half years after surgery. The study includes patients diagnosed with sacroiliitis who received the TransLoc 3D System implant commercially and have had it in place for at least one year, up to 18 months at the time of consent. No new treatments are administered instead, data is gathered through patient surveys and medical records, including CT scans performed as part of standard care. Participants will complete a patient satisfaction survey 12 to 18 months after surgery. Additional assessments include pain levels measured by the Visual Analogue Scale and disability measured by the Oswestry Disability Index, both recorded from baseline up to one year post-surgery. Safety is monitored through serious adverse events up to 90 days after surgery, and radiological evaluations occur between 12 and 18 months. The study relies on standard care follow-ups and lasts until data collection concludes in December 2024.

Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion