CHARITE™ vs. ALIF 5-Year Follow-up
This study has been completed.
Sponsor:
DePuy Spine
Information provided by:
DePuy Spine
ClinicalTrials.gov Identifier:
NCT00215332
First received: September 14, 2005
Last updated: May 15, 2008
Last verified: May 2008
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Purpose
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).
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Five-Year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage. |
Further study details as provided by DePuy Spine:
| Estimated Enrollment: | 367 |
| Study Start Date: | March 2005 |
| Study Completion Date: | July 2007 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215332
Locations
| United States, California | |
| Charite Site 13 | |
| Los Angeles, California, United States, 90048 | |
| United States, Colorado | |
| Charite Site 06 | |
| Golden, Colorado, United States, 80401 | |
| United States, Illinois | |
| Charite Site 11 | |
| Chicago, Illinois, United States, 60640 | |
| United States, Kentucky | |
| Charite Site 03 | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Charite Site 02 | |
| Towson, Maryland, United States, 21204 | |
| United States, Massachusetts | |
| Charite Site 15 | |
| Boston, Massachusetts, United States, 02120 | |
| United States, New York | |
| Charite Site 14 | |
| Lockport, New York, United States, 14094 | |
| Charite Site 10 | |
| New York, New York, United States, 10003 | |
| United States, Ohio | |
| Charite Site 07 | |
| Columbus, Ohio, United States, 43214 | |
| United States, Texas | |
| Charite Site 01 | |
| Plano, Texas, United States, 75093 | |
Sponsors and Collaborators
DePuy Spine
Investigators
| Study Director: | Daniel H Stoutenburgh | DePuy Spine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00215332 History of Changes |
| Other Study ID Numbers: | P040006 |
| Study First Received: | September 14, 2005 |
| Last Updated: | May 15, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by DePuy Spine:
|
arthroplasty lumbar disc |
Additional relevant MeSH terms:
|
Intervertebral Disk Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013