title: Clinical and Radiological Mid-Term Outcomes of Lumbar Single-Level Total Disc Replacement.
abstract: METHODS
  Prospective single-center case cohort study.
  
  
  OBJECTIVE
  Evaluation of clinical and radiographic outcomes of a consecutive 122-patient cohort with discogenic back pain, at 2- to 10-year follow-up periods, treated by a single surgeon, with CHARITÉ Artificial Disc (DePuy Spine, Raynham, MA).
  
  
  BACKGROUND
  Minimum 2-year clinical and radiographic level 1 data for the first lumbar artificial disc, the CHARITÉ Artificial Disc (DePuy Spine), have recently been published, demonstrating sustained clinical benefit of the device for the treatment of degenerative disc disease.
  
  
  METHODS
  Patients were assessed preoperatively using clinical outcome measures, including visual analog scale (VAS) score back and leg, Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), and Roland-Morris Questionnaires (RMDQ), and further assessed postoperatively, 3-, 6-, 12-months, and yearly thereafter.
  
  
  RESULTS
  Average follow-up was 44.9 ± 23.3 months (n = 122). The median age at surgery was 43.0 ± 9.0 years. Preoperative diagnosis included degenerative disc disease in 118 (96.7%) and internal disc disruption in 4 (3.3%). Surgery was performed at L5-S1 in 96 (77.9%) patients and at L4-L5 in 27 (22.1%). Statistically significant clinical improvements from baseline were observed on VAS (back and leg), ODI, SF-36 PCS, SF-36 MCS, and RMDQ 3 months onward. Back VAS scores decreased from 78.2 ± 21.3 preoperatively to 21.9 ± 27.8 by final follow-up. ODI scores decreased from 51.1 ± 17.3 to 16.2 ± 17.9 at last follow-up. The RMDQ scores also decreased from 16.7 ± 4.7 to 4.2 ± 5.8. SF-36 PCS and MCS increased from 25.7 ± 11.0 to 46.4 ± 10.3 for PCS and from 35.5 ± 17.4 to 51.6 ± 10.8 for MCS. Patient satisfaction surveys indicated that 90.56% patients rated their satisfaction with the surgery as "excellent" or "good" at 2 years. Range of motion averaged 8.6 ± 3.5 (median = 8.0°) at the last follow-up time point.
  
  
  CONCLUSIONS
  Outcomes verify the clinical efficacy of total disc replacement for treatment of discogenic back pain with or without radiculopathy. The outcomes instruments demonstrated statistically significant improvements 3 months onward.
  
  
  METHODS
  N/A.
authors.affiliation: Pacific Private Clinic, Gold Coast, Australia.|Bond University, Gold Coast, Australia.
authors.forename: Matthew N
authors.initials: MN
authors.lastname: Scott-Young
authors.affiliation: Western Imaging Group, Blacktown, NSW, Australia.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Lee
authors.affiliation: Pacific Private Clinic, Gold Coast, Australia.
authors.forename: David E A
authors.initials: DEA
authors.lastname: Nielsen
authors.affiliation: Pacific Private Clinic, Gold Coast, Australia.
authors.forename: Carly L
authors.initials: CL
authors.lastname: Magno
authors.affiliation: Pacific Private Clinic, Gold Coast, Australia.
authors.forename: Kristy R
authors.initials: KR
authors.lastname: Kimlin
authors.affiliation: Pacific Private Clinic, Gold Coast, Australia.
authors.forename: Evan O
authors.initials: EO
authors.lastname: Mitchell
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000000981:diagnostic imaging / Q000601:surgery*; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000601:surgery*; D017116:Low Back Pain / Q000000981:diagnostic imaging / Q000601:surgery*; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D011859:Radiography; D016059:Range of Motion, Articular; D011795:Surveys and Questionnaires; D059145:Total Disc Replacement; D016896:Treatment Outcome