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Lumbar total disc replacement options offer similar clinical outcomes
A newer FDA-approved lumbar total disc replacement product demonstrated similar safety and efficacy findings to a previously approved product, according to an FDA clinical trial.
Researchers performed a prospective, randomized trial to compare the safety and efficacy of the Kineflex-L Disc (SpinalMotion) and the Charité artificial disc (DePuy Spine). The study included the results of 457 patients from 21 sites who underwent total disc replacement surgery; 261 patients (204 randomized, 57 nonrandomized training cases) in the investigational group received the Kineflex-L Disc product, and 196 patients (190 randomized, 6 nonrandomized training cases) in the control group received the Charité artificial disc.
No statistical differences in operation time, loss of blood, or length of stay in the hospital were found between the two products, according to the researchers.
VAS pain and Oswestry Disability Index scores improved similarly at each follow-up through the entire 24-month follow-up period in both groups.
Success rates were similar between the investigational and control groups at 68.1% and 67.4%, respectively. Additionally, 94.1% of the investigational group and 91.9% of the control group were satisfied with outcomes by 24-month follow-up, according to the researchers.
Disclosure: One or more authors received consulting fee or honorarium; travel support; writing assistance, equipment or administrative support; and institutional support for writing the manuscript.
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Guyer RD. Spine. 2014. doi:10.1097/BRS.0000000000000319.