Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
Sponsored by DePuy Spine
About this trial
Last updated 11 years ago
Study ID
G990313
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
18 to 79 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 19 years ago
What is this trial about?
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.
What are the participation requirements?
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,