STUDY DESIGN: A prospective, randomized, multicenter study of surgical treatment of cervical disc disease. OBJECTIVE: To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up. SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success. METHODS: We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent asingle-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery. RESULTS: Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015). CONCLUSION: Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease.
RCT Entities:
STUDY DESIGN: A prospective, randomized, multicenter study of surgical treatment of cervical disc disease. OBJECTIVE: To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up. SUMMARY OF BACKGROUND DATA: Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success. METHODS: We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery. RESULTS: Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015). CONCLUSION: Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease.
Authors: Barbara Cappelletto; Fabrizia Giorgiutti; Claudio Veltri; Massimo A Trevigne; Paolo Facchin; Paolo Del Fabro Journal: Eur Spine J Date: 2013-09-18 Impact factor: 3.134