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Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.

TitelComparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial.
Publication TypeJournal Article
Year of Publication2009
AuthorsHeller, JG, Sasso, RC, Papadopoulos, SM, Anderson, PA, Fessler, RG, Hacker, RJ, Coric, D, Cauthen, JC, Riew, DK
JournalSpine
Volume34
Issue2
Pagination101-7
Date Published2009 Jan 15
ISSN1528-1159
SchlüsselwörterAdult, Aged, Arthroplasty, Cervical Vertebrae, Decompression, Surgical, Diskectomy, Endpoint Determination, Female, Humans, Intervertebral Disc, Intervertebral Disc Displacement, Male, Middle Aged, Neurosurgical Procedures, Postoperative Complications, Prospective Studies, Prostheses and Implants, Spinal Fusion, Treatment Outcome
Abstract 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.
DOI10.1097/BRS.0b013e31818ee263
Alternate JournalSpine
Full Text
PubMed ID19112337
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