Trials / Completed
CompletedNCT00291018
Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc-C to Anterior Cervical Discectomy and Fusion (ACDF) Surgery in the Treatment of Symptomatic Cervical Disc Disease (SCDD)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 368 (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-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Disc Replacement | Total Disc Replacement using ProDisc-C |
| DEVICE | ACDF | Anterior Cervical Discectomy and Fusion |
Timeline
- Start date
- 2003-08-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2006-02-13
- Last updated
- 2017-11-20
- Results posted
- 2017-03-08
Source: ClinicalTrials.gov record NCT00291018. Inclusion in this directory is not an endorsement.