Abstract
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.
Abstracts prepared by Mr. A. J. Stirling, FRCS, and Miss A. Weaver. Correspondence should be addressed to Miss A. Weaver at the Research and Teaching Centre, Royal Orthopaedic Hospital, Northfield, Birmingham, B31 2AP, UK
BritSpine 2002, the second combined meeting of the British Association of Spinal Surgeons, the British Cervical Spine Society, The British Scoliosis Society and the Society for Back Pain Research, took place at the International Convention Centre in Birmingham UK between 27th February and 1st March 2002. The following presentations and posters were given and displayed.
