NCT00456378

Study of the Safety and Effectiveness of DIAM™ Spinal Stabilization System Versus Conservative Care

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the safety and effectiveness of the DIAM™ Spinal Stabilization System in the treatment of moderate single-level lumbar degenerative disc disease.

Detailed description

This pivotal clinical trial is being conducted to evaluate the DIAM™ Spinal Stabilization System for the treatment of single-level moderate lumbar degenerative disc disease. The implant under investigation in this clinical trial is the DIAM Spinal Stabilization System, and the device will be implanted using a posterior surgical approach. Patients in the control group will receive nonoperative treatment.

Conditions

• Lumbar Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	DIAM™ Spinal Stabilization System	Surgical procedure with implantation of the Investigational device
PROCEDURE	Conservative care	Six months of conservative care, to include: patient education, medications, physical therapy and spinal injections.

Timeline

• Start date: 2006-12-01
• Primary completion: 2015-10-08
• Completion: 2018-11-20
• First posted: 2007-04-04
• Last updated: 2018-12-10

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated device study