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

NCT00215319 | Completed Phase 3

• 1 other identifier: G990313
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

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.

Conditions

Degenerative Disc Disease

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Radiographic Fusion

• Oswestry Disability Index

• Motor Function

• Adverse Events

• Secondary Surgical Interventions

Secondary Outcomes (5)

• SF-36

• Graft site pain

• Back pain

• Leg pain

• Disc space height

Study Arms (1)

TSM Cage

EXPERIMENTAL

Lumbar I/F with cage and pedicle screws

Device: Lumbar I/F with cage and pedicle screws

Interventions

Lumbar I/F with cage and pedicle screws DEVICE

Surgical Titanium Mesh™ with MOSS-Miami™ Pedicle Screws

TSM Cage

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• DePuy Spine: lead

Study Sites (2)

TSM Investigational Site A

Dothan, Alabama, 36301, United States

Location

TSM Investigational Site B

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Pedicle Screws

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2000
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 23, 2014

Record last verified: 2014-05

Locations

US (2)