Status:
UNKNOWN
DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
Lead Sponsor:
Companion Spine, LLC
Collaborating Sponsors:
MCRA
Conditions:
Low Back Pain
Eligibility:
All Genders
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 wi...
Eligibility Criteria
Inclusion
- 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
- NA
Key Trial Info
Start Date :
January 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2022
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT05201573
Start Date
January 17 2022
End Date
February 28 2022
Last Update
January 21 2022
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