Abstract
INTRODUCTION: Two total disc replacement devices have been used in Europe for more than 10 years. However, there are few, if any, prospective studies evaluating their results. The purpose of this prospective study using standardised outcome evaluations was to evaluate surgical outcome following implantation of an artificial disc.
METHODS: This study is based on the consecutive series of the first 57 patients undergoing total disc replacement using the SB Charité (Link) disc prosthesis. Indications included single-level symptomatic disc degeneration, failure of at least six months of non-operative treatment including active rehabilitation, and no previous surgery at the operated segment. Data were collected prospectively pre-operatively and at six weeks, three, six, and 12 months post-operatively (24 month follow-up data collection is continuing). Primary outcome measures included visual analog scales (VAS) assessing pain and the Oswestry Low Back Pain Disability Questionnaire.
RESULTS: The mean operative time was 78.5 minutes and the mean estimated operative blood loss was 134.3 cc. Estimated blood loss and operating time were both significantly less for disc replacements at the L5-S1 level than at L4-5 (p< 0.05; t-test). As seen in Figures 1 and 2, there was a significant improvement in the VAS and Oswestry scores (p< 0.05) at the six week follow-up visit, and the improvements were maintained during subsequent follow-up visits.
There were no cases of device failure, displacement, or migration. Complications were comparable to those encountered with anterior interbody fusion.
DISCUSSION: The results of this prospective study, using patient self-report questionnaires, demonstrated significant improvement at six weeks and the improvement was maintained during the 12 months follow-up period (24-months data is being collected). The disc prosthesis can be implanted safely, with complications similar to those encountered with anterior lumbar inter-body fusion.
These abstracts were prepared by Dr Robert J. Moore. Correspondence should be addressed to him at Spine Society of Australia, Institute of Medical and Veterinary Science, The Adelaide Centre for Spinal Research, Frome Road, Adelaide, South Australia 5000.
