A Prospective Randomized Comparison of Two Lumbar Total Disk Replacements
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.
KeywordsDisk Degeneration Oswestry Disability Index Disk Height Visual Analog Score Total Disk Replacement
- 2.Blumenthal S, McAfee PC, Guyer RD et al (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes. Spine 30:1565–1575CrossRefPubMedGoogle Scholar
- 6.Lemaire JP, Carrier H, Sariali el H et al (2005) Clinical and radiological outcomes with the Charité artificial disc: a 10-year minimum follow-up. J Spin Disord Tech 18: 353–359Google Scholar
- 8.McAfee PC, Cunningham B, Holsapple G et al (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITÉ artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine 30:1576–1583CrossRefPubMedGoogle Scholar
- 12.Zigler J, Delamarter R, Spivak JM et al (2007) Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease. Spine 32:1155–1162CrossRefPubMedGoogle Scholar