Status:
COMPLETED
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
Lead Sponsor:
DePuy Spine
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
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 dege...
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...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00215319
Start Date
December 1 2000
End Date
November 1 2006
Last Update
May 23 2014
Active Locations (2)
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1
TSM Investigational Site A
Dothan, Alabama, United States, 36301
2
TSM Investigational Site B
Fort Wayne, Indiana, United States, 46825