Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial

Abstract

Object A prospective, randomized clinical trial was conducted to compare the Prestige II Cervical Disc with anterior decompression and fusion for the treatment of single-level degenerative disease. Standardized clinical outcome measures and radiographic examinations were used at prescribed postoperative intervals to compare the treatment groups. Methods Patients with symptomatic single-level cervical disc disease who met the inclusion/exclusion criteria defined in the protocol were randomized to receive the Prestige II disc or iliac crest autograft fusion. All patients underwent a standardized neurological and radiographic examination and completed outcomes questionnaires (Neck Disability Index and Short Form–36) preoperatively and at each postoperative interval (6 weeks and 3, 6, 12, and 24 months). Two independent radiologists reviewed all x-ray films and assessed motion at the treated level and adjacent segments. Standard statistical methods were used to compare all outcome measures. Preliminary results in 55 patients enrolled in the study are presented. Several patients have reached the final (24-month) follow-up interval. Clinical and radiographic results are encouraging, with significant improvement seen in both treatment groups. Radiographic results show that the Prestige II disc maintains motion at the treated level without adjacent-segment compromise. Conclusions Cervical spine arthroplasty is an exciting and rapidly developing surgical treatment option. An objective comparison with fusion is important to advance this option. This is the first prospective randomized trial in which cervical arthroplasty is compared with fusion. The preliminary results from this limited number of patients indicate that the Prestige II disc is potentially a viable alternative to fusion for primary cervical disc disease; however, further clinical studies with larger sample sizes will be required to show statistical equivalence.