LUMBAR & SACROILIAC FUSION STUDY
Purpose
This study is a multi-center, observational, prospective and retrospective data collection study
Conditions
- Fusion of Spine
- Sacroiliac; Fusion
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This will involve patients previously commercially implanted with Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device.
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Previously implanted with lumbar and/or sacroiliac fusion device(s) |
This study will involve patients previously commercially implanted with Minuteman G5 MIS fusion plate, the Liberty sacroiliac fusion device, and/or the Patriot sacroiliac fusion device. Subjects will undergo a CT scan, if applicable and PROs. |
|
Recruiting Locations
Crimson Pain Management
Overland Park 4276873, Kansas 4273857 66209
Overland Park 4276873, Kansas 4273857 66209
Contact:
Morteza Rabii, NP
Morteza Rabii, NP
Nuroscience Research Center
Overland Park 4276873, Kansas 4273857 66210
Overland Park 4276873, Kansas 4273857 66210
Contact:
Amy Reinert
Amy Reinert
Nura Precision Pain Management
Edina 5025264, Minnesota 5037779 55435
Edina 5025264, Minnesota 5037779 55435
Contact:
Ken Farmer
Ken Farmer
More Details
- NCT ID
- NCT07204288
- Status
- Recruiting
- Sponsor
- Spinal Simplicity LLC
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.