DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

Study Overview
=================
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.

Official Title
-----------------
DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects historically treated with DIAM<br>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 | Other: Observational<br>* This is an observational study of long term follow up data for patients who previously received the DIAM implant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5-10 years after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back Pain evaluation | Composite overall success consisting of: Pain/disability (Oswestry) success (≥15 pt. improvement relative to baseline) No serious adverse event is classified as implant-associated, procedure associated or implant-/surgical procedure associated. No additional surgical procedure at the involved level is classified as a failure. | 5-10 years after implantation | 
| Back Pain evaluation | Change in back pain score compared to baseline | 5-10 years after implantation | 
| Back Pain evaluation | Back pain success calculated as: Pre-treatment Score - Post-treatment Score > 0 (Score = pain intensity + pain frequency) | 5-10 years after implantation | 
| Back Pain evaluation | SF-36/RAND-36 success calculated by: PCSPost-tx - PCSPre-tx > 0 | 5-10 years after implantation |