Prospective study evaluating total disc replacement: preliminary results.

For many years, there has been an interest in disc replacements. There are a few retrospective studies from Europe reporting promising results for these devices. The purpose of this study is to review the preliminary results of the SB Charité disc replacement device in a prospective study. The study group consists of a consecutive series of our first 57 patients who received the Link SB Charité device implanted through a mini-open anterior approach. The primary clinical indications for disc replacement were single-level symptomatic disc disease at L4-L5 or L5-S1 and no significant facet joint changes. The outcome data include the Visual Analog Scale (VAS) assessing pain intensity and the Oswestry Low Back Pain Disability Questionnaire. Data were collected prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery. Twenty-four-month follow-up data are currently being collected. The mean VAS score improved 50.8% by the 6-week follow-up, and significant improvement was maintained throughout follow-up. The mean Oswestry score improved 38.7% at the 6-week follow-up, and further slight improvement was noted during the later follow-up periods. This study found that significant improvements were achieved by the 6-week postoperative visit in the pain and disability scores following disc replacement surgery. Significant improvement was maintained through the 12-month follow-up visit. Although these preliminary results are encouraging, long-term follow-up and a greater number of patients are needed to further evaluate the outcome of these devices.