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Two- to 3-Year Follow-Up of ProDisc-L: Results From a Prospective Randomized Trial of Arthroplasty Versus Fusion

Jack E. Zigler, MD,1 Barton L. Sachs, MD,1 Ralph F. Rashbaum, MD,1 Donna D. Ohnmeiss, Dr Med1

1Texas Back Institute, Plano TX

Abstract 

Background

Although total disc replacement has been performed for years outside the United States, relatively little available data address clinical outcomes, particularly data from prospective studies. We report the 24- to 36-month follow-up of one center's experience with the ProDisc-L artificial disc as part of a prospective, randomized trial comparing total disc arthroplasty to combined anterior–posterior lumbar fusion.

Methods

The study involved clinical results for 157 patients from a single center enrolled in the US Food and Drug Administration–regulated trial comparing ProDisc-L to fusion. Only patients who had reached a minimum 24-month follow-up were included in the study. Patients were randomized to receive total disc replacement or circumferential fusion at 1 or 2 lumbar disc levels from L3 to S1, with specific inclusion and exclusion criteria. Data were collected preoperatively and at 6 weeks to 36 months postoperatively. The primary clinical outcome measures were Visual Analog Scale (VAS) scores to assess pain and Oswestry Disability Index (ODI) scores to measure function.

Results

The VAS and ODI scores in both treatment groups improved significantly as early as the 6-week follow-up visit and remained significantly improved throughout the 36-month follow-up period. Although a tendency was observed for the ProDisc-L scores to indicate more favorable outcome, the differences were not statistically significant. The proportion of patients who would have the same procedure again was greater in the total disc replacement group at all follow-up intervals, and significantly greater at the 6-month, 12-month, 24-month, and 36-month follow-up visits.

Conclusions

The results of this study indicate that the total disc replacement with ProDisc-L produces improvements in pain and function that are at least as good as those provided by circumferential fusion. During the long-term follow-up of 24 and 36 months, outcomes did not become less favorable compared with the early outcomes.

Clinical Relevance

We found that results of total disc replacement were at least as good as those achieved with combined instrumented anterior–posterior fusion for the treatment of painful disc degeneration. Favorable results were maintained during 24- and 36-month follow-up.

keywords: 
artificial disc, spine arthroplasty, lumbar spine, prospective study, spinal fusion
Volume 1 Issue 2
doi: 
10.1016/S1935-9810(07)70048-8