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.

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