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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: April 10, 2015
Last verified: April 2015

September 14, 2005
April 10, 2015
March 2005
Not Provided
Overall Success [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00215332 on ClinicalTrials.gov Archive Site
Secondary Endpoints [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency
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CHARITE™ vs. ALIF 5-Year Follow-up
Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.
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).

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.

Observational
Time Perspective: Prospective
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Degenerative Disc Disease
Device: CHARITE
Lumbar Total Disc Replacement
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
July 2007
Not Provided

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:

Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215332
P040006
No
Not Provided
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DePuy Spine
Not Provided
Study Director: Daniel H Stoutenburgh DePuy Spine
DePuy Spine
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP