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

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Abstract

Study Design:

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.

Summary of Background Data:

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.

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