Objectives To conduct a cost-utility analysis for two commonly used treatment strategies for patients after ACL rupture; early ACL reconstruction (index) versus rehabilitation plus an optional reconstruction in case of persistent instability (comparator). Methods Patients aged between 18 and 65 years of age with a recent ACL rupture (<2 months) were randomised between either an early ACL reconstruction (index) or a rehabilitation plus an optional reconstruction in case of persistent instability (comparator) after 3 months of rehabilitation. A cost-utility analysis was performed to compare both treatments over a 2-year follow-up. Cost-effectiveness was calculated as incremental costs per quality-adjusted life year (QALY) gained, using two perspectives: the healthcare system perspective and societal perspective. The uncertainty for costs and health effects was assessed by means of non-parametric bootstrapping. Results A total of 167 patients were included in the study, of which 85 were randomised to the early ACL reconstruction (index) group and 82 to the rehabilitation and optional reconstruction group (comparator). From the healthcare perspective it takes 48 460 € and from a societal perspective 78 179 €, to gain a QALY when performing early surgery compared with rehabilitation plus an optional reconstruction. This is unlikely to be cost-effective. Conclusion Routine early ACL reconstruction (index) is not considered cost-effective as compared with rehabilitation plus optional reconstruction for a standard ACL population (comparator) given the maximum willingness to pay of 20 000 €/QALY. Early recognition of the patients that have better outcome of early ACL reconstruction might make rehabilitation and optional reconstruction even more cost-effective. Data are available upon reasonable request. Data may be obtained from a third party and are not publicly available. We agree on data sharing to British Journal of Sports Medicine when required according to the World Health Organization and Nordic Trial Alliance declaration about clinical trial transparency.

中文翻译：

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ACL 急性断裂后重建 ACL 并不划算

目的 对 ACL 断裂后患者的两种常用治疗策略进行成本效用分析；早期 ACL 重建（指数）与康复加在持续不稳定情况下的可选重建（比较器）。方法 将 18 至 65 岁的近期 ACL 断裂（<2 个月）的患者随机分为早期 ACL 重建（指数）或康复加可选重建，以防 3 个月后持续不稳定（比较者）。复原。进行了成本效用分析，以在 2 年的随访中比较两种治疗方法。成本效益计算为每获得质量调整生命年 (QALY) 的增量成本，使用两个角度：医疗保健系统角度和社会角度。通过非参数引导法评估成本和健康影响的不确定性。结果共纳入167例患者，其中85例随机分配至早期ACL重建（索引）组，82例随机分配至康复和可选重建组（比较器）。从医疗保健的角度来看，与康复加可选的重建相比，在进行早期手术时需要 48 460 欧元和 78 179 欧元才能获得 QALY。这不太可能具有成本效益。结论 考虑到最高支付意愿为 20 000 欧元/QALY，对于标准 ACL 人群（比较者）而言，常规早期 ACL 重建（指数）与康复加可选重建相比不被认为具有成本效益。早期识别早期 ACL 重建具有更好结果的患者可能会使康复和可选重建更具成本效益。可应合理要求提供数据。数据可能从第三方获得并且不公开可用。根据世界卫生组织和北欧试验联盟关于临床试验透明度的声明，我们同意在需要时将数据共享给英国运动医学杂志。