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Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery — PDL  

Spinal Diseases Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00295009
Study type Interventional
Source Synthes USA HQ, Inc.
Contact
Status Completed
Phase N/A
Start date September 2001
Completion date April 2011
View Details
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