title: Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.
abstract: METHODS
  Prospective, randomized, single-center, clinical trial.
  
  
  OBJECTIVE
  To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF).
  
  
  BACKGROUND
  Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined.
  
  
  METHODS
  As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty.
  
  
  RESULTS
  Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055).
  
  
  CONCLUSIONS
  At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy.
  
  
  METHODS
  1.
authors.affiliation: Department of Research, Indiana Spine Group, Carmel, IN.
authors.forename: Willa R
authors.initials: WR
authors.lastname: Sasso
authors.affiliation: Indiana Spine Group, Carmel, IN.
authors.forename: Joseph D
authors.initials: JD
authors.lastname: Smucker
authors.affiliation: Department of Research, Indiana Spine Group, Carmel, IN.
authors.forename: Maria P
authors.initials: MP
authors.lastname: Sasso
authors.affiliation: Indiana Spine Group, Carmel, IN.
authors.forename: Rick C
authors.initials: RC
authors.lastname: Sasso
mesh_terms: D001178:Arthroplasty / Q000379:methods; D002574:Cervical Vertebrae / Q000601:surgery*; D017586:Diskectomy / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery*; D008297:Male; D019547:Neck Pain / Q000209:etiology; D010147:Pain Measurement / Q000379:methods; D011446:Prospective Studies; D016059:Range of Motion, Articular / Q000502:physiology*; D012086:Reoperation / Q000706:statistics & numerical data; D013123:Spinal Fusion / Q000379:methods; D013995:Time; D016896:Treatment Outcome