Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)

What this Trial Is About

Researchers are evaluating fusion outcomes and patient-reported experiences for individuals who previously received Spinal Simplicity's lumbar and/or sacroiliac fusion implants, including the Minuteman G5 MIS fusion plate, Liberty sacroiliac fusion device, and Patriot sacroiliac fusion device. This multi-center study combines both retrospective and prospective data collection to better understand the results of these implants. Participants in this study are those who have already been implanted with one or more of the specified devices between April 1, 2022, and March 31, 2025. The study involves collecting data retrospectively and prospectively, including CT scans when applicable to assess fusion, as well as patient-reported outcomes such as pain and disability measures. During the study, participants will undergo assessments including CT imaging if their device has not been removed, and will complete questionnaires covering pain levels, disability, global impression of change, and satisfaction. The primary outcome focuses on radiographic results, while secondary outcomes include numeric pain ratings, disability indexes, patient global assessments, and satisfaction surveys. The study is expected to continue until December 2026.

Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices