Trials / Terminated
TerminatedNCT00292292
Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)
Clinical Study Protocol for the Investigation of the Kineflex Spinal System - a Pivotal Study in Continued Access Stage
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 514 (actual)
- Sponsor
- SpinalMotion · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.
Detailed description
The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lumbar Artificial Disc | Insertion of the Kineflex Lumbar ArtificialDisc |
| DEVICE | Charite Artificial Disc | Insertion of the Charite |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2009-05-01
- Completion
- 2013-08-01
- First posted
- 2006-02-15
- Last updated
- 2013-09-13
Locations
21 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00292292. Inclusion in this directory is not an endorsement.