DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
Study Details
Study Description
Brief Summary
A hybrid prospective/retrospective, multicenter, single-arm, data collection study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.
Data collected at one-time point from subjects with at least 5 years of follow-up data.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subjects historically treated with DIAM Subjects randomized to the DIAM arm and treated with the DIAM™ Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study |
Other: Observational
This is an observational study of long term follow up data for patients who previously received the DIAM implant
|
Outcome Measures
Primary Outcome Measures
- Evaluate the safety associated with the use of the investigational implant during long term follow up [5-10 years after implantation]
The DIAM device, specifically at long-term follow-up. A subject is considered to be a long-term success if they are free from serious device-related adverse events through final follow-up. Secondary surgical intervention for treatment failure (i.e. recurrence of pain or functional impairment) without other serious device-related adverse event is not considered to be a serious device-related adverse event for the purposes of the primary endpoint.
Secondary Outcome Measures
- Back Pain evaluation [5-10 years after implantation]
Composite overall success consisting of: Pain/disability (Oswestry) success (≥15 pt. improvement relative to baseline) No serious adverse event is classified as "implant-associated", "procedure associated" or "implant-/surgical procedure associated." No additional surgical procedure at the involved level is classified as a failure.
- Back Pain evaluation [5-10 years after implantation]
Change in back pain score compared to baseline
- Back Pain evaluation [5-10 years after implantation]
Back pain success calculated as: Pre-treatment Score - Post-treatment Score > 0 (Score = pain intensity + pain frequency)
- Back Pain evaluation [5-10 years after implantation]
SF-36/RAND-36 success calculated by: PCSPost-tx - PCSPre-tx > 0
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
-
Willing and able to consent to study procedures
Exclusion Criteria:
- NA
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Companion Spine, LLC
- MCRA, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP21001