Status:
COMPLETED
CHARITE™ vs. ALIF 5-Year Follow-up
Lead Sponsor:
DePuy Spine
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
Brief 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 orig...
Eligibility Criteria
Inclusion
- Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,
- Still have the original implant they received in their index surgery.
Exclusion
- None
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00215332
Start Date
March 1 2005
End Date
July 1 2007
Last Update
April 13 2015
Active Locations (10)
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1
Charite Site 13
Los Angeles, California, United States, 90048
2
Charite Site 06
Golden, Colorado, United States, 80401
3
Charite Site 11
Chicago, Illinois, United States, 60640
4
Charite Site 03
Louisville, Kentucky, United States, 40202