Trials / Completed
CompletedNCT00215332
CHARITE™ vs. ALIF 5-Year Follow-up
Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 367 (estimated)
- Sponsor
- DePuy Spine · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
Detailed description
This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF. This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CHARITE | Lumbar Total Disc Replacement |
Timeline
- Start date
- 2005-03-01
- Completion
- 2007-07-01
- First posted
- 2005-09-22
- Last updated
- 2015-04-13
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00215332. Inclusion in this directory is not an endorsement.