A MULTICENTER, PROSPECTIVE, RANDOMIZED, STUDY OF AN ARTIFICIAL CERVICAL DISC VERSUS FUSION FOR PRIMARY CERVICAL DISC SURGERY. (2004)

Introduction: A prospective, randomized, controlled study has been conducted to compare the clinical outcomes of patients treated with an Artificial Cervical Disc to patients who receive fusion after cervical discectomy for the treatment of primary cervical disc disease. It is hypothesized that maintenance of motion after anterior cervical discectomy will prevent the high rate of adjacent level premature degeneration. The primary purpose of the study is to prove equivalence (non inferiority) of outcome of the disc prosthesis in the short term compared with fusion.<br/><br/>Methods: In four centers, 60 patients with primary, single level cervical disc disease producing radiculopathy and/or myelopathy are randomized prospectively to receive anterior cervical discectomy with either fusion or artificial cervical disc placement. The patients are evaluated with pre and postoperative serial flexion-extension cervical x-rays at 6 weeks, 3, 6, 12, and 24 months. At the same intervals, the patients have pre and postoperative neck disability indexes, visual pain analogue scales, European myelopathy scores, SF-36 general health scores, and neurological status examinations assessing the patient’s reflex, motor and sensory function.<br/><br/>Results: Data is presented for the first 47 patients. At 6 weeks the neck disability index reduced by 36.1 for the investigational group compared to 34.8 for the fusion group. The pain score had reduced by 8.2 for the investigational group and by 9.9 for the control group. This improvement appeared to be maintained until the 12 month followup. In general there appeared to be a slightly better outcome for the investigational group. Both pain score and disability scores improved statistically significantly compared to the pre op scores (p<0.001 all comparisons). Analysis of non inferiority of outcome for the investigational group using ANCOVA with the preoperative score as the covariate and a non inferiority margin of 5 points showed statistical significance at 6 and 12 weeks for Neck disability index. Operative time appeared slightly less (2.3 hrs) for the investigational group compared to the fusion group(2.5hrs). Blood loss also appeared higher in the fusion group (165 mls compared to 91 mls). Hospital stay was equivalent (2.8 days and 2.9 days).<br/><br/>Discussion: Anterior cervical discectomy and fusion has a good short term outcome though there is a high incidence of failure at adjacent levels over time. It is hypothesized that the maintenance of motion of a segment will prevent adjacent premature degeneration. It will take long term followup studies however to prove this. In the mean time, the justification to insert artificial cervical prostheses rests on being able to prove equivalence of outcome between fusion and prosthesis in the short term. This paper shows that the outcomes appear to be equivalent. Early statistical evidence is available for some of the outcome measures at early post op followup. Further statistical power will be available when the full 60 cases are available for study and this may give further weight to the hypothesis of equivalence of outcome.