DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

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.

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