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

NCT ID: NCT00215319

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-12-31
• Study Completion Date: 2006-11-30

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.

Conditions

Degenerative Disc Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TSM Cage

Lumbar I/F with cage and pedicle screws

Group Type: EXPERIMENTAL

Lumbar I/F with cage and pedicle screws

Intervention Type: DEVICE

Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws

Interventions

Lumbar I/F with cage and pedicle screws

Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws

Intervention Type: DEVICE

Eligibility 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TSM Investigational Site A

Dothan, Alabama, United States

TSM Investigational Site B

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

G990313

Identifier Type: -

Identifier Source: org_study_id