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CHARITE™ vs. ALIF 5-Year Follow-up

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215332
First Posted: September 22, 2005
Last Update Posted: April 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
DePuy Spine
  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 Intervention Phase
Degenerative Disc Disease Device: CHARITE 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.

Resource links provided by NLM:


Further study details as provided by DePuy Spine:

Primary Outcome Measures:
  • Overall Success [ Time Frame: 5 Years ]
    ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline.


Secondary Outcome Measures:
  • Secondary Endpoints [ Time Frame: 5 Years ]
    Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency


Estimated Enrollment: 367
Study Start Date: March 2005
Study Completion Date: July 2007
Groups/Cohorts Assigned Interventions
Training- CHARITE
Non-Randomized Training (TDR with CHARITE)
Device: CHARITE
Lumbar Total Disc Replacement
CHARITE
Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE
Device: CHARITE
Lumbar Total Disc Replacement
Control
Randomized Subjects treated by ALIF with BAK cage

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00215332     History of Changes
Other Study ID Numbers: P040006
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: April 13, 2015
Last Verified: April 2015

Keywords provided by DePuy Spine:
arthroplasty
lumbar
disc

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases