Clinical and radiological outcomes with the CHARITE™ artificial disc -: A 10-year minimum follow-up

This is the first report of clinical and radiologic outcomes for the CHARITE (TM) artificial disc with a minimum follow-up of 10 years. A total of 107 patients indicated for total lumbar disc replacement were implanted with the CHARITE (TM) prosthesis. Of these 107, 100 were followed for a minimum of 10 years (range 10-13.4 years). A total of 147 prostheses were implanted with 54 one-level and 45 two-level procedures and I three-level procedure. The prostheses were placed through a standard anterior retroperitoneal approach. Clinically, 62% had an excellent outcome, 28% had a good outcome, and 10% had a poor outcome. Of the 95 eligible to return to work, 88 (91.5%) either returned to the same job as prior to surgery or a different job. These included 63.2% (12) of those working in heavy labor employment returning to the same job. Mean flexion/extension motion was 10.3 degrees for all levels (12.0 degrees at L3-L4, 9.6 degrees at L4-L5, 9.2 degrees at L5-S1). Mean lateral motion was 5.4 degrees. In the sagittal plane, 9 (6.1%) were anterior of geometric center, 50 (34.0%) were centered, and 88 (59.9%) were posterior of center. In the frontal plane, 110 (75%) were centered, and 37 (25%) were noted to be lateral to center. Slight subsidence was observed in two patients, but they did not require further Surgery. No subluxation of the prostheses and no cases of spontaneous arthrodesis were identified. There was one case of disc height loss of 1 mm. Five patients required a secondary posterior arthrodesis. A good or excellent clinical outcome rate of 90% and a return to work rate of 91.5% compare favorably with results described in the literature for fusion for the treatment of lumbar degenerative disc disease. With a minimum follow-up of 10 years, the CHARITE (TM) artificial disc demonstrated excellent flexion/extension and lateral range of motion with no significant complications.