DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Back Pain
- Sponsor
- Companion Spine, LLC
- Enrollment
- 175
- Primary Endpoint
- Evaluate the safety associated with the use of the investigational implant during long term follow up
- Last Updated
- 4 years ago
Overview
Brief Summary
A hybrid prospective/retrospective, multicenter, single-arm, data collection study.
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.
Investigators
Eligibility 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
- Not provided
Outcomes
Primary Outcomes
Evaluate the safety associated with the use of the investigational implant during long term follow up
Time Frame: 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 Outcomes
- Back Pain evaluation(5-10 years after implantation)