Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CHARITE™ vs. ALIF 5-Year Follow-up

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.
 
ClinicalTrials.gov Identifier: NCT00215332
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 13, 2015
Sponsor:
Information provided by:
DePuy Spine

Tracking Information
First Submitted Date September 14, 2005
First Posted Date September 22, 2005
Last Update Posted Date April 13, 2015
Study Start Date March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: April 10, 2015)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00215332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 10, 2015)
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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CHARITE™ vs. ALIF 5-Year Follow-up
Official Title Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.
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 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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Degenerative Disc Disease
Intervention Device: CHARITE
Lumbar Total Disc Replacement
Study Groups/Cohorts
  • Training- CHARITE
    Non-Randomized Training (TDR with CHARITE)
    Intervention: Device: CHARITE
  • CHARITE
    Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE
    Intervention: Device: CHARITE
  • Control
    Randomized Subjects treated by ALIF with BAK cage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September 14, 2005)
367
Original Enrollment Same as current
Actual Study Completion Date July 2007
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00215332
Other Study ID Numbers P040006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor DePuy Spine
Collaborators Not Provided
Investigators
Study Director: Daniel H Stoutenburgh DePuy Spine
PRS Account DePuy Spine
Verification Date April 2015