Spine
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: Lumbar total disc replacement, now in use since 2004, was determined by the panel to be a standard of care for the treatment of symptomatic single-level lumbar degenerative disc disease in the active patient subpopulation as outlined by the investigational device exemption study criteria. The large body of evidence supporting this statement, including surgeons' experiences, was presented and discussed. Consensus statements focusing on decision-making criteria reflected that efficacy, long-term safety, clinical outcomes with validated measures, and cost-effectiveness should form the basis of decision-making by payers. Diagnostic challenges with lumbar degenerative disc disease patients were discussed among the panel, and it was concluded that although variably used among surgeons, reliable tools exist to appropriately diagnose discogenic back pain.
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Retrospective analysis of prospective data. ⋯ 2.
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: Consensus statements regarding the evidence-base for lumbar total disc replacement, as it pertains to payer decision-making, were developed through a modified-Delphi technique involving 17 spine surgeons and a former payer medical director. The Delphi process involved one round of anonymous survey and one round with a face-to-face meeting. The survey was a 51-item, electronically administered questionnaire to determine level of agreement with proposed statements on the evidence for lumbar total disc replacement and to provide additional diagnosis and management practice information for further deliberations. ⋯ The voting processes during meeting deliberations remained anonymous. Consensus was defined as ≥ 90% agreement. Consensus was reached on 11 statements, divided into themes that focused on patient eligibility and diagnosis, evidence criteria for coverage decisions, clinical evidence, and budgetary implications.
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A retrospective review of prospectively collected clinical and radiologic data of patients with magnetically controlled growing rods (MCGRs) from a multi-centered study with a minimum of 2-year follow-up. ⋯ 4.