Failure to Launch: What the Rejection of Lumbar Total Disk Replacement Tells us About American Spine Surgery.

Abstract

Spine surgeon survey. The objective was to investigate the failure of widespread adoption of lumbar total disk replacement (L-TDR) in the United States. 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. 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. 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. 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.