Archive for the 'J Neurosurg Spine' Category
Cervical disc arthroplasty: a controlled randomized prospective study with intermediate follow-up results. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2005.
0 Comments Published by Administrator January 1st, 2006 in PubMed Medical Devices, Regulatory Affairs, J Neurosurg SpineCervical disc arthroplasty: a controlled randomized prospective study with intermediate follow-up results. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2005.
J Neurosurg Spine. 2005 Dec;3(6):424-8
Authors: Hacker RJ
OBJECT: The authors of studies of anterior cervical fusion for disc-related disease have documented satisfying clinical results and infrequent complications. Recently, cervical disc arthroplasty has entered clinical trials as an alternative to fusion. Although the results of anecdotal reports and prospective studies support this procedure, these studies have not conferred the validity of a controlled randomized study. In the present study, the author presents data obtained in such a study. METHODS: After symptoms failed to respond to conservative therapy, 46 patients with one-level discogenic cervical radiculopathy and/or myelopathy were randomized to undergo arthroplasty or fusion as part of a US Food and Drug Administration medical device study. In all patients there was a minimum follow-up duration of 1 year. Equivalent results for the relief of arm pain and neck pain were noted in both treatment groups. Treatment parameters other than operative time were similar. No neurological or serious systemic complications occurred. CONCLUSIONS: Although extended follow-up data and larger patient populations are needed, the results of this study indicate that arthroplasty is a viable alternative to cervical fusion.
PMID: 16381203 [PubMed - in process]
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