• Richard Assaker, Karsten Ritter-Lang, Dominique Vardon, Stéphane Litrico, Stéphane Fuentes, Michael Putzier, Jörg Franke, Peter Jarzem, Pierre Guigui, Gérard Nakach, and Jean-Charles Le Huec.
• Service de Neurochirurgie, Centre Hospitalier Régional Universitaire, Hôpital Roger Salengro, 2 Avenue Oscar Lambret, 59037, Lille Cedex, France, richardassaker@gmail.com.
• Eur Spine J. 2015 Sep 1; 24 (9): 2047-55.

PurposeControlled trials have shown that total disc replacement (TDR) can provide pain and disability relief to patients with degenerative disc disease; however, whether these outcomes can also be achieved for patients treated in normal surgical practice has not been well documented.MethodsThis prospective, international study observed changes in disability and back pain in 134 patients who were implanted with Maverick TDR within the framework of routine clinical practice and followed for 2 years post-surgery. Primary and secondary outcomes were the differences from baseline to 6 months post-surgery in the means of the Oswestry Disability Index and the change in back pain intensity assessed on a 10-cm visual analogue scale, respectively. Mean patient age at surgery was 43 years, but ranged up to 65 years.ResultsOne hundred twenty-three patients had an implant at one level, 10 patients at two levels, and one patient at three levels. Statistically significant improvements in mean disability (-25.4) and low back pain intensity (-4.0) scores were observed at 6 months postoperatively (P < 0.0001 for both) in the hands of experienced surgeons (>10 TDRs per centre). During the study, 56 patients (42 %) experienced a complication or adverse event.ConclusionsThis is the first international observational study to report outcomes of TDR in real-world clinical settings. We showed statistically significant improvements in disability and pain scores at 6 months following Maverick TDR, which were maintained for 2 years alongside an acceptable rate of perioperative complications. The safety and tolerability shown in this observational study were comparable to those from controlled trials.

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