Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CHARITE™ vs. ALIF 5-Year Follow-up

This study has been completed.
Sponsor:
Information provided by:
DePuy Spine
ClinicalTrials.gov Identifier:
NCT00215332
First received: September 14, 2005
Last updated: May 15, 2008
Last verified: May 2008
  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).


Condition Phase
Degenerative Disc Disease
Phase 4

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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014