Lumbar and sacroiliac fusion with previously implanted devices
Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)
This project will collect past and new data to see how well Spinal Simplicity lumbar and sacroiliac fusion implants work for adults who already received them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spinal Simplicity LLC Industry-sponsored |
| Locations | 3 sites (Overland Park, Kansas and 2 other locations) |
| Trial ID | NCT07204288 on ClinicalTrials.gov |
What this trial studies
This multi-center observational project combines retrospective chart review with prospective follow-up to document fusion outcomes and patient-reported results after implantation of Spinal Simplicity devices. It targets patients who received the Minuteman G5 MIS fusion plate, the Liberty sacroiliac device, and/or the Patriot sacroiliac device between April 1, 2022 and March 31, 2025. Data collection includes clinical records, imaging such as CT when applicable, and standardized patient-reported outcome measures. The goal is to characterize real-world device performance and postoperative outcomes across participating sites.
Who should consider this trial
Good fit: Adults aged 18 or older who received a Minuteman G5, Liberty, or Patriot implant between April 1, 2022 and March 31, 2025 and who can provide consent and attend follow-up (including imaging) are eligible.
Not a fit: People who are pregnant, cannot provide informed consent, or have a contraindication to CT scanning may not be eligible and therefore may not benefit from participation.
Why it matters
Potential benefit: If successful, the project could give doctors and patients clearer real-world information about fusion rates, symptoms, and device performance after lumbar or sacroiliac implantation.
How similar studies have performed: Post-market registries and observational outcome collections for spinal fusion devices have previously provided useful safety and effectiveness data, so this approach follows established real-world evidence methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be 18 years of age or older at the time of enrollment 2. Be willing and able to provide informed consent and comply with study visit requirements 3. Subjects who received a Spinal Simplicity fusion implant(s) (Minuteman G5, Liberty, and/or Patriot) between April 1, 2022 and March 31, 2025 Exclusion Criteria: 1. Unable to provide consent and complete prospective data collection 2. Women who are pregnant, or may become pregnant, during the course of the study 3. Contraindication to CT scanning, in the opinion of the investigator
Where this trial is running
Overland Park, Kansas and 2 other locations
- Crimson Pain Management — Overland Park, Kansas, United States (Recruiting)
- Nuroscience Research Center — Overland Park, Kansas, United States (Recruiting)
- Nura Precision Pain Management — Edina, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Echo Cundiff
- Email: ecundiff@spinalsimplicity.com
- Phone: 9134514414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.