Long-term outcome after implantation of the Prestige I disc in an end-stage indication: 4-year results from a pilot study.

Abstract

OBJECT: The long-term function of an artificial cervical disc device is critical to its clinical success. The Prestige I Cervical Disc System has been used clinically since June 1998, and long-term results can now begin to be assessed. The authors conducted clinical and radiographic examinations at 3 and 4 years postoperatively to evaluate the longterm performance of the Prestige I device. METHODS: A pilot trial was initiated in which the Prestige I disc was implanted in a cohort of patients with end-stage disease, who often had a history of multiple previous fusion procedures. All patients were followed according to a standardized clinical and radiographic protocol until 2 years postoperatively. Outcome measures included the Short Form-36 (SF-36) and Neck Disability Index (NDI) questionnaires, neurological status, and radiographic status. To evaluate the long-term function of the device, Ethics Committee approval was obtained to assess the patients at 3 and 4 years postoperatively. All patients were contacted, and after signing an additional informed consent document, were reevaluated according to the standardized protocol. Of the 17 patients in the original cohort, 13 were evaluated at 3 years and 14 were evaluated at 4 years postoperatively. Clinical outcome measures including the NDI and SF-36 showed good improvement, especially when the endstage nature of the disease is considered. Radiographic analysis showed that the Prestige I disc maintained motion at the treated segment at 3 and 4 years postoperatively. CONCLUSIONS: In this report the authors demonstrate the clinical viability of the Prestige I cervical disc system at long-term postoperative intervals, even in the more severe biomechanical environment of end-stage disease.