title: Failure to Launch: What the Rejection of Lumbar Total Disk Replacement Tells us About American Spine Surgery.
abstract: METHODS
  Spine surgeon survey.
  
  
  OBJECTIVE
  The objective was to investigate the failure of widespread adoption of lumbar total disk replacement (L-TDR) in the United States.
  
  
  BACKGROUND
  L-TDR has been available for use in the United States since 2005. L-TDR has not gained wide acceptance as a treatment for degenerative disk disease despite substantial investments in product development and positive results in randomized controlled trials.
  
  
  METHODS
  Estimates of the number of L-TDR procedures performed in the United States from 2005 to 2010 were calculated using the Nationwide Inpatient Sample database. Insurance policies were assessed for L-TDR coverage through Internet search. Finally, an 18-question survey regarding surgeons' opinions toward L-TDR was distributed to the members of North American Spine Society.
  
  
  RESULTS
  The estimated number of primary L-TDR procedures performed in the United States decreased from 3650 in 2005 to 1863 in 2010, whereas revision L-TDR procedures increased from 420 to 499. Of 14 major insurers, 11 (78.6%) do not cover L-TDR. In total, 613 spine surgeons responded to the survey. Over half of respondents (51.1%, 313/612) have performed L-TDR, although only 44.6% (136/305) of initial adopters currently perform the surgery. However, 81.5% (106/130) of those currently performing L-TDR have been satisfied with the results. When asked about their perceptions of L-TDR, 65.0% (367/565) indicated a lack of insurance coverage for L-TDR in their region, 54.9% (310/565) worry about long-term complications, and 52.7% (298/565) worry about the technical challenges of revision.
  
  
  CONCLUSIONS
  Despite early enthusiasm for L-TDR, wide adoption has not occurred. A primary reason for this failure seems to be a lack of insurance coverage, despite intermediate-term clinical success. In addition, surgeons continue to express concerns regarding long-term outcomes and the technical difficulties of revision. This case study of a failed surgical innovation may signal increasing involvement of payers in clinical decision-making and may be instructive to surgeons, policymakers, and manufacturers.
authors.affiliation: *Department of Orthopedics and Rehabilitation, Oregon Health and Science University, Portland, OR †Department of Orthopaedics, Warren Alpert School of Medicine, Brown University, Providence, RI.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hart
authors.forename: J Mason
authors.initials: JM
authors.lastname: DePasse
authors.forename: Alan H
authors.initials: AH
authors.lastname: Daniels
mesh_terms: D002986:Clinical Trials as Topic; D003710:Demography; D006801:Humans; D007341:Insurance; D008159:Lumbar Vertebrae / Q000601:surgery*; D066231:Surgeons; D011795:Surveys and Questionnaires; D059145:Total Disc Replacement