DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-17

Study Completion Date

2022-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Observational

Intervention Type OTHER

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

Interventions

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Observational

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

Intervention Type OTHER

Eligibility Criteria

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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