749996
Last Update Posted: 2016-01-28
Recruiting has ended
All Genders accepted | 20 Years-60 Years |
165 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.
This study is a multi-center, prospective, randomized, controlled trial. Patients will be randomized in 2 groups:
Investigational group: a single level herniectomy procedure, followed by placement of the DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure; After surgery, patients will be followed for a 2 years period with required follow up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).
Eligibility
Relevant conditions:
Sciatica
Back Pain
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov