NCT07204288NARecruiting
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
Spinal Simplicity LLC
Start Date
9/11/2025
Completion Date
12/1/2026
Summary
This study is a multi-center, observational, prospective and retrospective data collection study
Detailed 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 Criteria
Age Range: 18 years to No maximum
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
OTHER
Cat Scan, if applicable
Conditions
Fusion of SpineSacroiliac; Fusion
Locations
Crimson Pain Management
Overland Park, Kansas 66209
United States
Nuroscience Research Center
Overland Park, Kansas 66210
United States
Nura Precision Pain Management
Edina, Minnesota 55435
United States