DePuy Spine sponsored a two-year randomized IDE study of 304 total patients. 205 patients received the CHARITÉ® Artificial Disc and 99 patients received a commercially available interbody fusion device. The study evaluated the safety and efficacy of the CHARITÉ® Artificial Disc compared to interbody fusion for the treatment of single-level degenerative disc disease (DDD) from L4 to S1. The results of the study were as follows:
The CHARITÉ® Artificial Disc was shown to be safe and effective in the treatment of DDD at one level from L4 to L5.
Compared to baseline, the CHARITÉ® Artificial Disc provided pain reduction from 6 weeks out to 24 months as measured by the Visual Analog Scale (VAS). Patients with the CHARITÉ® Artificial Disc exhibited a 49% decrease in 6 weeks with a 57% decrease by 24 months.
The CHARITÉ® Artificial Disc provided improvement in pain and function as measured by the Oswestry Disability Index (ODI) when compared to anterior interbody fusion.
The mean Range of Motion (ROM) for CHARITÉ® Artificial Disc subjects was 5.0, 6.1, 6.9, and 7.5 degrees at 3, 6, 12, and 24 months respectively.
The CHARITÉ® Artificial Disc provided maintenance of mean post-operative disc height of 12.9mm at 24 months as compared to 10.7mm at 24 months for anterior interbody fusion.
At 24 months, 70% of patients with the CHARITÉ® Artificial Disc would definitely choose the same treatment again and 12% would probably choose the same treatment again, compared to 50% and 14% respectively for anterior interbody fusion patients.
At 24 months, 74% of patients with the CHARITÉ® Artificial Disc were satisfied and 15% were somewhat satisfied, compared to 53% and 25% respectively for anterior interbody fusion patients.
The CHARITÉ® Artificial Disc allowed segmental motion at the operative level.
Mean operative time and mean estimated blood loss were similar between both groups.
Patients who received the CHARITÉ® Artificial Disc were discharged from the hospital on average in 3.7 days compared to 4.2 for anterior interbody fusion patients.
