Back Pain Clinical Trial
Official title:
Herniectomy vs. 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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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