I'm wondering if this report on Charité III disc replacements is bad as it sounds, or am i misinterpreting something?
Survival and clinical outcome of SB Charite III disc replacement for back pain -- Ross et al. 89-B (6): 785 -- Journal of Bone and Joint Surgery - British Volume
Journal of Bone and Joint Surgery - British Volume, Vol 89-B, Issue 6, 785-789.
Copyright © 2007 by British Editorial Society of Bone and Joint Surgery
Survival and clinical outcome of SB Charité III disc replacement for back pain
R. Ross, MBChB, FRCS(Ed), FRACS, Spinal Surgeon1; A. H. Mirza, MBChB, MRCS(Ed), Spinal Fellow1; H. E. Norris, BA(Hons), RGN, Research Nurse1; and M. Khatri, MS(Orth), FRCS(Tr & Orth), Consultant Spinal & Orthopaedic Surgeon1
1 Salford Royal NHS Foundation Trust, Eccles Old Road, Salford, Manchester M6 8HD, UK.
Correspondence should be sent to Mr R. Ross; e-mail:
ersross@hotmail.co.uk
Between January 1990 and December 2000 we carried out 226 SB Charité III disc replacements for lumbar disc degeneration in 160 patients. They were reviewed at a mean follow-up of 79 months (31 to 161) to determine the clinical and radiological outcome. The clinical results were collected by an independent observer, who was not involved in patient selection, treatment or follow-up, using a combination of outcome measures, including the Oswestry Disability Index. Pain was recorded using a visual analogue score, and the most recent radiographs were reviewed.
Survival of the device was analysed by the Kaplan-Meier method and showed a cumulative survival of 35% at 156 months when radiological failure was taken as the endpoint. The mean improvement in the Oswestry disability index scores after disc replacement was 14% (6% to 21%) and the mean improvement in the pain score was 1.6 (0.46 to 2.73), both falling below the clinically significant threshold. Removal of the implant was required in 12 patients, four because of implant failure.
These poor results indicate that further use of this implant is not justified.