DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

N/AUnknownNCT05201573

Companion Spine, LLC175 enrolled

Overview

A hybrid prospective/retrospective, multicenter, single-arm, data collection study.

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 Type

OBSERVATIONAL

Enrollment

175

Conditions

Low Back Pain

Interventions

ObservationalOTHER

This is an observational study of long term follow up data for patients who previously received the DIAM implant

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evaluate the safety associated with the use of the investigational implant during long term follow up

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.