BACKGROUND AND PURPOSE The posterolateral and direct lateral surgical approach are the 2 most common surgical approaches for performing a hemiarthroplasty in patients with a hip fracture. It is unknown which surgical approach is preferable in terms of (cost-)effectiveness and quality of life. METHODS AND ANALYSIS We designed a multicenter randomized controlled trial (RCT) with an economic evaluation and a natural experiment (NE) alongside. We will include 555 patients ≥ 18 years with an acute femoral neck fracture. The primary outcome is patient-reported health-related quality of life assessed with the EQ-5D-5L. Secondary outcomes include healthcare costs, complications, mortality, and balance (including fear of falling, actual falls, and injuries due to falling). An economic evaluation will be performed for quality adjusted life years (QALYs). We will use variable block randomization stratified for hospital. For continuous outcomes, we will use linear mixed-model analysis. Dichotomous secondary outcome measures will be analyzed using chi-square statistics and logistic regression models. Primary analyses are based on the intention-to-treat principle. Additional as treated analyses will be performed to evaluate the effect of protocol deviations. Study summary: (i) Largest RCT addressing the health-related patient outcome of the main surgical approaches of hemiarthroplasty. (ii) Focus on outcomes that are important for the patient. (iii) Pragmatic and inclusive RCT with few exclusion criteria, e.g., patients with dementia can participate. (iv) Natural experiment alongside to amplify the generalizability. (v) The first study conducting a costutility analysis comparing both surgical approaches.

中文翻译：

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股骨颈骨折后骨水泥股骨头置换术的后外侧或直接外侧入路 (APOLLO)：多中心随机对照试验的方案，同时进行经济评估和自然实验。

背景和目的后外侧和直接外侧手术入路是对髋部骨折患者进行股骨头置换术的两种最常见的手术入路。就（成本）效益和生活质量而言，尚不清楚哪种手术方法更可取。方法和分析 我们设计了一项多中心随机对照试验 (RCT)，其中包含经济评估和自然实验 (NE)。我们将纳入 555 名 ≥ 18 岁的急性股骨颈骨折患者。主要结果是患者报告的使用 EQ-5D-5L 评估的健康相关生活质量。次要结果包括医疗费用、并发症、死亡率和平衡能力（包括对跌倒的恐惧、实际跌倒和跌倒造成的伤害）。将对质量调整生命年 (QALY) 进行经济评估。我们将使用针对医院分层的变量块随机化。对于连续结果，我们将使用线性混合模型分析。将使用卡方统计和逻辑回归模型分析二分次要结果测量。主要分析基于意向治疗原则。将进行额外的处理分析以评估方案偏差的影响。研究摘要：(i) 最大的 RCT 解决了股骨头置换术主要手术方法与健康相关的患者结果。(ii) 关注对患者重要的结果。(iii) 具有极少排除标准的务实和包容性随机对照试验，例如痴呆症患者可以参与。(iv) 自然实验，以扩大普遍性。