NCT00627497

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Lumbar Spinal Stenosis

Interventions

Type	Name	Description
PROCEDURE	Single-Level Posterior Decompression	The single level posterior decompression is a posterior surgical procedure.
DEVICE	DIAM Spinal Stabilization	The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach.
DEVICE	DIAM Spinal Stabilization	The DIAM Spinal Stabilization System is a spacer that is implanted between adjoining spinous processes using a posterior surgical approach
DEVICE	Fusion	Posterolateral Interbody Fusion

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-03-03
• Last updated: 2021-01-05
• Results posted: 2012-04-24

Locations

9 sites across 1 country: United States