Trials / Completed
CompletedNCT00295009
Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 852 (actual)
- Sponsor
- Synthes USA HQ, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ProDisc | Total disc replacement with ProDisc |
| PROCEDURE | Spinal Fusion | A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation. |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2006-02-22
- Last updated
- 2014-08-06
- Results posted
- 2014-08-01
Source: ClinicalTrials.gov record NCT00295009. Inclusion in this directory is not an endorsement.