Status:
RECRUITING
LUMBAR & SACROILIAC FUSION STUDY
Lead Sponsor:
Spinal Simplicity LLC
Conditions:
Fusion of Spine
Sacroiliac; Fusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Be 18 years of age or older at the time of enrollment
- Be willing and able to provide informed consent and comply with study visit requirements
- Subjects who received a Spinal Simplicity fusion implant(s) (Minuteman G5, Liberty, and/or Patriot) between April 1, 2022 and March 31, 2025
Exclusion
- Unable to provide consent and complete prospective data collection
- Women who are pregnant, or may become pregnant, during the course of the study
- Contraindication to CT scanning, in the opinion of the investigator
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07204288
Start Date
September 11 2025
End Date
April 1 2026
Last Update
October 2 2025
Active Locations (3)
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1
Crimson Pain Management
Overland Park, Kansas, United States, 66209
2
Nuroscience Research Center
Overland Park, Kansas, United States, 66210
3
Nura Precision Pain Management
Edina, Minnesota, United States, 55435