Lumbar and sacroiliac fusion with previously implanted devices
Official title: Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)
Run by Spinal Simplicity LLC · NCT07204288 · Data updated 2026-11-12
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
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Spinal Simplicity LLC Industry-sponsored |
| Locations | 7 sites (Kansas City, Kansas and 6 other locations) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | January 2027 |
| Study ends | April 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07204288 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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University of Kansas Medical Center
Kansas City, Kansas, United States Recruiting -
Nura Precision Pain Management
Edina, Minnesota, United States Recruiting -
Southern Oklahoma Pain Management
Ardmore, Oklahoma, United States Recruiting -
The Spine and Nerve Center
Charleston, West Virginia, United States Recruiting -
Crimson Pain Management
Overland Park, Kansas, United States Completed -
Nuroscience Research Center
Overland Park, Kansas, United States Completed
Show 1 more location
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Spine Institute of North America
East Windsor, New Jersey, United States Completed
Study contacts
- Study coordinator: Echo Cundiff
- Email: ecundiff@spinalsimplicity.com
- Phone: 9134514414
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.