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Sponsored by: |
Synthes Spine |
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Information provided by: | Synthes Spine |
ClinicalTrials.gov Identifier: | NCT00295009 |
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine. There will be separate study arms for one and two level cases.
Condition | Intervention |
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Spinal Diseases |
Device: Total disc replacement |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc to Spinal Fusion Surgery in the Treatment of Discogenic Pain Associated With DDD in the Lumbosacral Spine |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | PDL-07272001 |
Study First Received: | February 20, 2006 |
Last Updated: | February 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00295009 |
Health Authority: | United States: Food and Drug Administration |
Spinal Diseases Musculoskeletal Diseases Pain Bone Diseases |