Status:
COMPLETED
CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease
Lead Sponsor:
DePuy Spine
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of th...
Detailed Description
Treatments for disc degeneration have historically included conservative modalities, such as rest, heat, electrotherapy, physical therapy, and analgesics to surgery. Currently, there are two main surg...
Eligibility Criteria
Inclusion
- 18 to 60 years of age inclusive
- symptomatic degenerative disc disease confirmed by provocative discogram
- single level disease L4/L5 or L5/S1
- leg or back pain without nerve root compression
- VAS pain score \>= 40
- Oswestry Disability Index score \>= 30
- six months prior conservative treatment
- appropriate for anterior surgical approach
Exclusion
- previous lumbar or thoracic fusion
- other spinal surgery at target level
- symptomatic multiple level degeneration
- non-contained or extruded nucleus pulposus
- compression or burst at L4, L5, or S1 due to trauma
- mid-sagittal stenosis \< 8mm
- osteoporosis, osteopenia, or other metabolic bone disease of the spine
- spondylolisthesis \> 3mm, scoliosis \> 11 degrees
- facet joint arthrosis
- isthmic spondylolisthesis
- positive straight leg raise for radiculopathy
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00215306
Start Date
March 1 2000
End Date
March 1 2004
Last Update
May 23 2014
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