Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years.
The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lumbar Degenerative Disc Disease Treated With|
- Radiographic fusion [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.
- Quality of Life using the SF-12 Scale [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
- Pain Scores on the Visual Analog Scale [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
- Functional improvement using the Oswestry Disability Index [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||February 2011|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Interbody fusions with Anterior Plating
Device: Interbody Fusion
allograft spacer + anterior plate
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323387
|Principal Investigator:||Kirkham Wood, MD||Mass. General Hospital|