Objective: To assess the safety and efficacy of a novel Artificial Cervical Disc.

Design: Compare the Bryan prosthesis to Anterior Cervical Discectomy and Fusion (ACDF), by using the pre-defined objective performance criteria (OPC) derived from a literature meta-analysis of ACDF in which a success rate of 73% was established. The Null hypothesis is that the success rate for the Bryan prosthesis is greater or equal to the OPC (Objective Performance Criteria) of 85%. Secondary Objectives studied included the range of motion after implantation; adverse events from implantation onwards; maintenance of the disc space height; amount of subsidence. Radiology was assessed by an independent radiologist. Improvement in the quality of life for the patient (SF-36) was also recorded at six weeks, six months and one year. Data was collected by an independent research practitioner.

Subjects: Multicentre study seven European centres: 107 patients Male 51, Female 66. Age ranged from 27 to 71. Mean age was 42 years with a clinical diagnosis of cervical radiculopathy or myelopathy, and single level disc disease on MRI.

Outcome Measures: Odom Criteria, SF-36, radiological range of movement.

Results: The Bryan Cervical Disc was associated with a clinical success according to Odom’s criteria of 87%. Radiological success occurred in 97%. SF-36 analysis revealed a statistically significant improvement in all domains.

Conclusion: The Bryan Disc has been successfully implanted in 107 patients with good clinical results and at one-year follow-up there is radiological evidence of preserved motion.