Lumbar & Sacroiliac Fusion Study: Multi-Center Prospective Radiographic Study on Subjects Previously Implanted With Spinal Simplicity Lumbar and/or Sacroiliac Fusion Device(s)
Spinal Simplicity LLC
Summary
This study is a multi-center, observational, prospective and retrospective data collection study
Description
The purpose of this study is to evaluate fusion outcomes and patient-reported outcomes for Spinal Simplicity's lumbar and/or sacroiliac fusion implants: the Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. This will involve identifying patients previously implanted with any of these devices and conducting both retrospective and prospective data collection/analysis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- OtherCat Scan, if applicable
CT imaging is being used to assess fusion in participants with previously implanted devices that were not explanted.
Locations (3)
- Crimson Pain ManagementOverland Park, Kansas
- Nuroscience Research CenterOverland Park, Kansas
- Nura Precision Pain ManagementEdina, Minnesota