RESUMO
STUDY DESIGN: Randomized clinical trial with 2-year follow-up. OBJECTIVE: To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment. METHODS: We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio. RESULTS: The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886-3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: -0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700. CONCLUSION: The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate. LEVEL OF EVIDENCE: 2.