title: Maverick total disc replacement in a real-world patient population: a prospective, multicentre, observational study.
abstract: OBJECTIVE
  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.
authors.affiliation: Service de Neurochirurgie, Centre Hospitalier Régional Universitaire, Hôpital Roger Salengro, 2 Avenue Oscar Lambret, 59037, Lille Cedex, France, richardassaker@gmail.com.
authors.forename: Richard
authors.initials: R
authors.lastname: Assaker
authors.forename: Karsten
authors.initials: K
authors.lastname: Ritter-Lang
authors.forename: Dominique
authors.initials: D
authors.lastname: Vardon
authors.forename: Stéphane
authors.initials: S
authors.lastname: Litrico
authors.forename: Stéphane
authors.initials: S
authors.lastname: Fuentes
authors.forename: Michael
authors.initials: M
authors.lastname: Putzier
authors.forename: Jörg
authors.initials: J
authors.lastname: Franke
authors.forename: Peter
authors.initials: P
authors.lastname: Jarzem
authors.forename: Pierre
authors.initials: P
authors.lastname: Guigui
authors.forename: Gérard
authors.initials: G
authors.lastname: Nakach
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Le Huec
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000601:surgery*; D007595:Joint Prosthesis; D017116:Low Back Pain / Q000453:epidemiology / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011843:Radiculopathy / Q000453:epidemiology; D012008:Recurrence; D012042:Registries; D059145:Total Disc Replacement / Q000379:methods*; D055815:Young Adult