Abstract
Introduction: While anterior cervical decompression and fusion has been shown to be clinically effective in cases of myelopathy or radiculopathy, several studies have suggested an increased risk of development of adjacent segment degeneration. The Bryan Cervical Disc Pros-thesis was developed to address this complication and was fi rst used clinically in Europe in January 2000. The author began to use the device in June of 2001 and since that time has implanted 30 prostheses in 22 patients. The present prospective study was commenced at the time (concurrently with an ASERNIPS study) with a view to examine the clinical efficacy and safety of this device. The results in the author’s first 14 patients are reported, all with a minimum follow-up of 12 months (mean 20 months).
Methods: An observational audit of 14 consecutive patients with cervical radiculopathy (6 patients), myelopathy (6 patients) or discogenic neck pain (2 patients) operated upon between July 2001 and November 2002. Average age was 48 years (range 27 – 61 years). 5 patients underwent two level procedures. Operative / post-op complications and clinical / radiological outcomes were recorded at 6 weeks, 3, 6, 12 months and January 2004.
Results: Follow-up data is available at > 12 months on 13 of the 14 patients at an average 23 months post op (Range: 14–30 months). The patient for whom data is not available is known to have had a poor clinical outcome. She developed an unusual symptom complex with complex regional pain syndrome and is very unhappy with the surgery. Of the other 13 patients, 12 consider their outcome to have been excellent and 1 fair. In the two patients who underwent surgery purely for discogenic neck pain, substantial relief was reported. In the 8 patients with pre-operative arm pain, 6 reported complete relief, 1 substantial relief and one partial relief. There were no intra-operative complications. Two patients developed dysphagia which resolved after several months, one has described a clicking sensation in his neck for which no cause has been identified and one experiences persistent ‘neural surges’. One patient required surgery for a disc herniation at an adjacent level, 9 months post-op while in another patient, on routine 12 month follow-up MRI scan, an asymptomatic disc herniation adjacent to the operated segment had resolved spontaneously. One patient underwent foraminotomy for recurrent arm pain, 19 months post-op. All prostheses appear mobile on dynamic x-rays but it is apparent that the Bryan device does not correct any pre-operative degenerative deformity using the current technique.
Discussion: The current study appears to indicate satisfactory clinical outcomes at an average of 23 months post surgery in this group of patients. Longer follow-up and larger patient numbers are required as well as comparative studies.
The abstracts were prepared by I. B. McPhee. Correspondence should be addressed to the Spine Society of Australia Secretariat, The Adelaide Centre for Spinal Research, Institute of Medical and Veterinary Science, PO Box 14, Rundle Mall, Adelaide SA 5000, Australia.
