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

Sponsor

DePuy Spine (Industry)

Overall Status

Completed

CT.gov ID

NCT00215319

Collaborator

(none)

139

Enrollment

Locations

Arm

Duration (Months)

69.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease	Device: Lumbar I/F with cage and pedicle screws	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

139 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2000

Actual Primary Completion Date :

Nov 1, 2006

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TSM Cage Lumbar I/F with cage and pedicle screws	Device: Lumbar I/F with cage and pedicle screws Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws

Arm

Intervention/Treatment

Experimental: TSM Cage

Lumbar I/F with cage and pedicle screws

Device: Lumbar I/F with cage and pedicle screws

Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws

Outcome Measures

Primary Outcome Measures

Radiographic Fusion []
Oswestry Disability Index []
Motor Function []
Adverse Events []
Secondary Surgical Interventions []

Secondary Outcome Measures

SF-36 []
Graft site pain []
Back pain []
Leg pain []
Disc space height []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TSM Investigational Site A	Dothan	Alabama	United States	36301
2	TSM Investigational Site B	Fort Wayne	Indiana	United States	46825

Sponsors and Collaborators

DePuy Spine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DePuy Spine

ClinicalTrials.gov Identifier:

NCT00215319

Other Study ID Numbers:

G990313

First Posted:

Sep 22, 2005

Last Update Posted:

May 23, 2014

Last Verified:

May 1, 2014

Keywords provided by DePuy Spine

Degenerative disc disease at up to 2 levels (L2-S1)

Additional relevant MeSH terms:

Intervertebral Disc Degeneration

Study Results

No Results Posted as of May 23, 2014