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Clinical Trial Summary

The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAMâ„¢ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.


Clinical Trial Description

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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00749996
Study type Interventional
Source Medtronic Spinal and Biologics
Contact
Status Completed
Phase Phase 4
Start date November 2006
Completion date June 2013

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