STUDY DESIGN: Economic evaluation alongside a prospective, randomized controlled trial from a secondary care National Health Service (NHS) perspective. OBJECTIVE: To determine the cost-effectiveness of titanium cages (TC) compared with femoral ring allografts (FRA) in circumferential lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: A randomized controlled trial has shown the use of TC to be clinically inferior to the established practice of using FRA in circumferential lumbar fusion. Health economic evaluation is urgently needed to justify the continued use of TC, given that this treatment is less effective and, all things being equal, is assumed more costly than FRA. METHODS: Eighty-three patients were randomly allocated to receive either the TC or FRA as part of a circumferential lumbar fusion between 1998 and 2002. NHS costs related to the surgery and revision surgery needed during the trial period were monitored and adjusted to the base year (2005-2006 Pounds Sterling). The Short Form-6D (SF-6D) was administered before surgery and at 6, 12 and 24 months in order to elicit patient utility and subsequently Quality-Adjusted Life Years (QALYs) for the trial period. Return to paid employment was also monitored. Bootstrapped mean differences in discounted costs and benefits were generated in order to explore cost-effectiveness. RESULTS: A significant cost difference of pound 1950 (95% CI, pound 849 to pound 3145) in favor of FRA was found. Mean QALYs per patient over the 24-month trial period were 0.0522 (SD, 0.0326) in the TC group and 0.1914 (SD, 0.0398) in the FRA group, producing a significant difference of -0.1392 (95% CI, -0.2349 to -0.0436). With regard to employment, incremental productivity costs were estimated at pound 185,171 in favor of FRA. CONCLUSION: From an NHS perspective, the trial data show that TC is not cost-effective in circumferential lumbar fusion. The use of FRA was both cheaper and generated greater QALY gains. In addition, FRA patients reported a greater return to work rate.
Spine (philadelphia), 2007, Vol 32, Issue 25, p. 2891-2897
Awards and Prizes; Bone Transplantation; Chronic Disease; Cost of Illness; Cost-Benefit Analysis; Disability Evaluation; Employment; England; Equipment Design; Femur; Health Care Costs; Humans; Low Back Pain; Lumbar Vertebrae; Orthopedic Fixation Devices; Pain Measurement; Prospective Studies; Quality-Adjusted Life Years; Questionnaires; Reoperation; Reproducibility of Results; Spinal Fusion; Time Factors; Titanium; Treatment Outcome