Results from the Charité artificial disc

Results from the CharitÈ Artificial Disc

The FDA IDE multicenter trial of the Charité artificial disc was performed at 15 centers across the US. Qualified study patients were randomized between fusion (99 patients) and placement of the Charité disc (205 patients). Key findings of the study include:

Charité artificial disc was found to be safe and effective for the treatment of degenerative disc disease compared to traditional spinal fusion
57% of patients receiving the artificial disc rated their surgery a success compared to 46% in the fusion control group (p<.001)
Patients receiving the artificial disc had a statistically significant lower Oswestry Disability Index score (rating scale to measure function) than the fusion control group at 6 weeks, 3, 6, and12 months
Patients receiving the artificial disc had a statistically significant lower VAS pain score than the fusion control group at 6 weeks, 3, 6, and 12 months
At 24 months follow-up, over 70% of patients receiving the artificial disc were satisfied with their surgery, compared to only 55% of the fusion control group patients (p=.0011)
At 24 months follow-up, nearly 70% of patients receiving the artificial disc would choose the same treatment again, compared to 50% of the fusion control group patients (p=.0062)

Overall, patients receiving the artificial disc regained function faster, had less post-operative pain and indicated a better quality of life than the patients in the fusion control group. Complication rates for both the artificial disc and fusion groups were similar.