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DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion

Degenerative Lumbar Spinal Stenosis Clinical Trial

Official title:
A Prospective, Randomized, Controlled Pivotal Clinical Investigation of DIAM™ Spinal Stabilization System in Patients With Degenerative Lumbar Spinal Stenosis.

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.

Clinical Trial Description

This pivotal clinical trial is being conducted to evaluate the DIAM Spinal Stabilization System for the treatment of single-level degenerative lumbar spinal stenosis from L2 to L5. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System. And following a decompression procedure, the device will be implanted using a posterior surgical approach. Patients in the control group will receive a lumbar decompression. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00627497
Study type Interventional
Source Medtronic Spinal and Biologics
Contact
Status Terminated
Phase Phase 3
Start date February 2008
Completion date December 2010
View Details
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