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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215319
• Other study ID #: G990313
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 22, 2014
• Start date: December 2000
• Est. completion date: November 2006

Study information

• Verified date: May 2014
• Source: DePuy Spine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

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

Intervention

Device:
• Lumbar I/F with cage and pedicle screws
Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws

Locations

Country	Name	City	State
United States	TSM Investigational Site A	Dothan	Alabama
United States	TSM Investigational Site B	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Fusion			No
Primary	Oswestry Disability Index			No
Primary	Motor Function			Yes
Primary	Adverse Events			Yes
Primary	Secondary Surgical Interventions			Yes
Secondary	SF-36			No
Secondary	Graft site pain			No
Secondary	Back pain			No
Secondary	Leg pain			No
Secondary	Disc space height			No