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

Purpose

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	Intervention	Phase
Degenerative Disc Disease	Device: Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws	Phase III

Drug Information available for:

S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by DePuy Spine:

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

Estimated Enrollment:	146
Study Start Date:	December 2000

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.

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215319

Locations


United States, Alabama
	TSM Investigational Site A
	Dothan, Alabama, United States, 36301

United States, Indiana
	TSM Investigational Site B
	Fort Wayne, Indiana, United States, 46825

Sponsors and Collaborators

DePuy Spine

More Information

Study ID Numbers:	G990313
First Received:	September 13, 2005
Last Updated:	October 4, 2006
ClinicalTrials.gov Identifier:	NCT00215319
Health Authority:	United States: Food and Drug Administration

Keywords provided by DePuy Spine:

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

Study placed in the following topic categories:

Spinal Diseases

Musculoskeletal Diseases

Bone Diseases

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	DePuy Spine
Information provided by:	DePuy Spine
ClinicalTrials.gov Identifier:	NCT00215319