Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.

Degenerative Disc Disease Clinical Trial

Official title: A Multi-center Study to Evaluate the Safety and Efficacy of DePuy AcroMed Titanium Surgical Mesh and MOSS-Miami Spinal Fixation System Pedicle Screws for Intradiscal Fusion in the Lumbar Spine

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the lumbar spine. The observed success rate at 24 months will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System.

Clinical Trial Description

This is a single arm multi-center study to determine the clinical success of the DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two adjacent levels of degenerative disc disease of the lumbar spine (L2

• S1).

Study Success is as a compound endpoint requiring:

• Radiographic Fusion,

• Improvement in Pain/Function,

• Maintenance/Improvement in Neurologic Status, and

• Freedom from Secondary Surgical Intervention.

• The rate of Adverse Events must be no worse than in the control group as well.

Secondary Endpoints Include:

• Adverse Events

• SF-36 Health Related Quality of Life

• Disc Space Height

• Work Status

Comparison:

Results will be compared to an historical control group treated with the Lumbar I/F Cage with VSP System. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

• NCT number: NCT00215319
• Study type: Interventional
• Source: DePuy Spine
• Status: Completed
• Phase: Phase 3
• Start date: December 2000
• Completion date: November 2006