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

Completed · Phase 3

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT00215319

Run by

DePuy Spine

People needed

139

Starts

2000-12-01

Expected to finish

2006-11-01

Last updated by the study team

2014-05-23

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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,

Where it is running

• TSM Investigational Site A — Dothan, Alabama, United States
• TSM Investigational Site B — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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