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.
Study Type
OBSERVATIONAL
Enrollment
367
Lumbar Total Disc Replacement
Charite Site 13
Los Angeles, California, United States
Charite Site 06
Golden, Colorado, United States
Charite Site 11
Chicago, Illinois, United States
Charite Site 03
Louisville, Kentucky, United States
Overall Success
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.
Time frame: 5 Years
Secondary Endpoints
Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency
Time frame: 5 Years
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Charite Site 02
Towson, Maryland, United States
Charite Site 15
Boston, Massachusetts, United States
Charite Site 14
Lockport, New York, United States
Charite Site 10
New York, New York, United States
Charite Site 07
Columbus, Ohio, United States
Charite Site 01
Plano, Texas, United States