A Prospective Randomized Comparison of Two Lumbar Total Disk Replacements

Abstract

Lumbar total disk replacement (TDR) has been used since the 1980s in Europe for the treatment of painful disk degeneration. While there have been many papers published on case series and more recently randomized trials comparing TDR to fusion, there is little information available on the direct clinical comparison of different implants. The purpose of this study was to report preliminary, 12-month follow-up results, of a multicenter prospective randomized trial comparing the Kineflex-L to the Charite for the treatment of single-level symptomatic disk degeneration. Data are presented for 85 patients from two of the centers participating in the study. Operative and peri-operative values were similar based on blood loss, operative time, and length of hospital stay. Both groups improved significantly based on visual analog scales assessing pain and the Oswestry Disability Index, with no significant differences between the groups on these assessments. Radiographically, the mean disk height was increased after TDR, and the range of motion values at the implanted level was similar in the two groups. The results of this study found that when employing rigorous selection criteria, results of TDR are consistent. Data for more patients continue to be collected through 24-month follow-up for these and other patients in the multicenter trial.