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

Journal of Neurosurgery. Spine
Domagoj CoricPeggy Boltes

Abstract

The authors report on a prospective randomized controlled multicenter trial in which they compared the clinical outcomes obtained in patients who underwent the placement of a Bryan Cervical Disc System with those obtained in patients who underwent anterior cervical discectomy and fusion (ACDF). In the present study, they evaluated the safety and effectiveness of the artificial disc based on data obtained at a single investigational site. Patients with primary, single-level cervical disc disease producing radiculopathy and/or myelopathy were randomized prospectively to undergo anterior cervical discectomy with either fusion or artificial disc placement. The patients were evaluated with pre- and postoperative serial radiographic studies; the authors also evaluated neck disability indices, visual analog scale scores for pain, 36-Item Short Form Health Survey scores, and neurological status at 1.5, 3, 6, 12, and 24 months. Analysis of the early results obtained in the 33 patients indicated an absence of device-related complications. Preliminary analysis revealed that improvement in all clinical outcome measures was excellent for both treatment groups; however, in patients treated with the artificial cervical disc, motion at the tre...Continue Reading

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Citations

May 18, 2013·Archives of Orthopaedic and Trauma Surgery·Zhenxiang ZhangWenjie Zhang
Aug 28, 2007·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Seok Woo KimPaul C McAfee
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