Trials / Terminated
TerminatedNCT00374413
Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)
Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 343 (actual)
- Sponsor
- SpinalMotion · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to show that the Kineflex\|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.
Detailed description
The Kineflex\|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Artificial disk | Implant |
| DEVICE | Artificial disc | Implant |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2010-01-01
- Completion
- 2013-08-01
- First posted
- 2006-09-11
- Last updated
- 2013-09-13
Locations
21 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00374413. Inclusion in this directory is not an endorsement.