Maverick total disc replacement in a real-world patient population: a prospective, multicentre, observational study

• Published in: European spine journal Vol. 24; no. 9; pp. 2047 - 2055
• Main Authors: Assaker, Richard, Ritter-Lang, Karsten, Vardon, Dominique, Litrico, Stéphane, Fuentes, Stéphane, Putzier, Michael, Franke, Jörg, Jarzem, Peter, Guigui, Pierre, Nakach, Gérard, Le Huec, Jean-Charles
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-09-2015; Springer Nature B.V; Springer Verlag
• Subjects: Adult; Aged; Female; Humans; Intervertebral Disc Degeneration - surgery; Joint Prosthesis; Life Sciences; Low Back Pain - epidemiology; Low Back Pain - surgery; Lumbar Vertebrae - surgery; Male; Medicine; Medicine & Public Health; Middle Aged; Neurosurgery; Original Article; Pain Measurement; Postoperative Complications - epidemiology; Prospective Studies; Radiculopathy - epidemiology; Recurrence; Registries; Surgical Orthopedics; Total Disc Replacement - methods; Young Adult; Intervertebral disc degeneration; Arthroplasty; Total disc replacement; Registry; Prospective study; Lumbar vertebrae
• ISSN: 0940-6719; 1432-0932
• DOI: 10.1007/s00586-015-3918-x

Purpose
Controlled 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.
Methods
This 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.
Results
One 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.
Conclusions
This 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.