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

Phase 3

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: Lumbar I/F with cage and pedicle screws

• Registration Number: NCT00215319
• Lead Sponsor: DePuy Spine

Brief 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.

Detailed 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 Timeline

• Study Start: 2000-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

• Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
• Radiographic evidence of significant disc degeneration at one or two of the adjacent lumbar levels L2-S1.

Exclusion Criteria

• Abnormality at more than two levels,
• Prior fusion surgery of the lumbar spine; prior discectomies or IDET allowed,
• Infection in the disc or spine, past or present,
• Active infection at time of surgery,
• Tumor in the spine,
• Significant osteoporosis or metabolic bone disease,
• Greater than Grade I spondylolisthesis or significant bony defect in the lumbar spine,
• Pregnant or lactating, or wishes to become pregnant within duration of study,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TSM Cage	Lumbar I/F with cage and pedicle screws	Lumbar I/F with cage and pedicle screws

Primary Outcome Measures

Name	Time	Method
Radiographic Fusion
Oswestry Disability Index
Motor Function
Adverse Events
Secondary Surgical Interventions

Secondary Outcome Measures

Name	Time	Method
SF-36
Graft site pain
Back pain
Leg pain
Disc space height

Trial Locations

Locations (2)

TSM Investigational Site A; 🇺🇸 Dothan, Alabama, United States

TSM Investigational Site B; 🇺🇸 Fort Wayne, Indiana, United States