Introduction: A prospective randomized study of artifical disc replacement vs. lumbar fusion for one-level disc pathology with 2 year minimum follow-up was completed in compliance with a U.S. FDA protocol.

Methods: A total of 15 investigational sites enrolled 375 subjects with a randomization in a 2:1 ratio. Of the 375, 205 were randomized to receive the Charité artificial disc, and 99 were randomized to receive anterior lumbar interbody fusion with BAK cages. An additional group of 71 patients received the Charité disc as “training cases” prior to beginning randomization. Clinical outcome measures included VAS, Oswestry Disability Index, and SF-36 Healthy Surveys. A total of 6,900 radiographs were digitized throughout the 24 month treatment interval. The 276 disc replacement patients were allocated into one of three groups based on radiographic technical paramenters-- Group I – Ideal, defined as Charité disc placement within 3 mm of ideal in both planes. Coronal plane = AP radiograph = midline or within 3 mm of midline. Mid-Sagittal plane = Lateral radiograph = 2mm posterior to middle of vertebral body or within 3mm of this axis. Group II —Suboptimal (not ideal) and Group III – Poor.

Results: The Charité prosthesis was significantly more effective than BAK in restoring the height of the collapsed disk space (p < 0.001). In Charité cases, the mean initial disc space height at the L5-S1 operative level was 5.2 mm +/− 1.44 (Std Dev) and increased to a mean of 13.5 mm +/− 1.18 (Std Dev). For BAK, the initial disc space height was 5.9.mm +/− 1.74 and increased to an immediate post-operative disk space height of 11.9 mm +/− 2.07. There was less subsidence with the Charite disk replacement than the BAK control at 2 years (p < 0.001). Of the 276 subject radiographs analysed with Charité disc replacement, 83% were classified as Group I, 11% as Group II, and 6% as Group III.

The mean Oswestry Disability Index scores at 2 years correlated with technical accuracy in placement of the prosthesis: Group I – 24.1; Group II – 30.3; and Group III – 36.3 (p < .05). The Mean VAS scores at 2 years correlated with technical accuracy in placement of the prosthesis: Group I – 28.3; Group II – 35.4; and Group III – 48.4 (p = 0.016). The mean flexion/extension range of motion and prosthesis function also correlated with device placement: Group I – 7.12 +/− 4.06 degrees; Group II – 7.47 +/− 4.41 degrees; and Group III – 3.15 +/− 3.51 degrees (p = 0.003).

Discussion: The surgical technical accuracy of Charité artificial disc placement correlated with clinical outcome, range of motion, and device functionality at 2 years. The Charité Lumbar Disk replacement proved to be a successful alternative to traditional lumbar fusion in every parameter. The results from this U.S. Investigational study confirm that proper placement of the Charité artificial disc improves clinical and radiological outcomes.

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.

Introduction: There is a great deal of interest in intervertebral disc arthroplasty. These devices have been used in Europe for more than 10 years. There have been several reports published on the European results when using the SB Charité III (link) prosthesis and good results have been reported in 63% to 79% of patients^1,2,3. The purpose of this prospective study was to evaluate surgical outcome following implantation of an artificial disc.

Methods: The SB Charité III device has two cobalt chromium plates with a polyethylene core between them. Motion occurs through articulation between the concave/convex surfaces of the plates and core. The disc prosthesis is implanted using the same approach as used for anterior lumbar interbody fusion procedures. It comes in multiple sizes to accommodate variations in individual patient size.

The disc has been implanted in 39 patients in our clinic. This group includes 19 males and 20 females (mean age 39.8 years, range 26 to 54 years). The primary study inclusion criteria were single-level symptomatic disc degeneration, failure of at least six months of non-operative treatment, and no previous surgery at the operated segment. Outcome measures included neurological examination, radiographic assessment, Oswestry Low Back Pain Disability Questionnaire, visual analog scale (VAS) assessing pain, SF-36, and work status. Data were collected pre-operatively, and at six weeks, three, six, and 12 months post-operatively. To date, 22 patients have reached the 12 months follow-up point.

Results: Overall, patients demonstrated improvement in the self-reported outcome measures. The mean VAS score improved approximately 50% at the six weeks follow-up and this improvement was maintained during subsequent follow-up. The Oswestry scores improved 37% at six weeks follow-up and had improved by 50% at subsequent follow-ups. Radiographic assessment revealed no cases of device displacement or migration. Complications were comparable to those reported for anterior lumbar interbody fusion. There have been no cases of device failure.

Discussion: The results of this prospective study, using patient self-report questionnaires, demonstrated good clinical outcome. There was a significant improvement noted six weeks post-operatively that was maintained during the follow-up visits. The disc prosthesis can be implanted safely, with complications similar to those encountered with anterior lumbar interbody fusion. As with any surgical procedure, long-term prospective follow-up is needed and data will be collected as these patients reach 24 months follow-up.