Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site

In this preliminary study, 33 patients with primary, single-level cervical disc disease and radiculopathy/myelopathy were randomized to undergo anterior cervical disectomy with the Bryan Cervical Disc System or with fusion (ACDF). The primary outcomes were safety and effectiveness (clinical outcomes including pain and disability) of the artificial disc compared to fusion. Results indicated that all patients reported an absence of device-related complications and had comparable improvements in all the clinical outcomes.