DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

• Conditions: Low Back Pain
• Interventions: Other: Observational

• Registration Number: NCT05201573
• Lead Sponsor: Companion Spine, LLC

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-06
• Study Start: 2022-01-17
• Study First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects historically treated with DIAM	Observational	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Back Pain evaluation	5-10 years after implantation	SF-36/RAND-36 success calculated by: PCSPost-tx - PCSPre-tx \> 0