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

September 14, 2005
May 15, 2008
March 2005
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Complete list of historical versions of study NCT00215332 on ClinicalTrials.gov Archive Site
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
July 2007
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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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215332
P040006
No
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DePuy Spine
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Study Director: Daniel H Stoutenburgh DePuy Spine
DePuy Spine
May 2008

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