Department of Orthopedic Surgery, Joint Research, OLVG Hospital, Amsterdam, the Netherlands.
Department of Internal Medicine and Geriatrics, Amsterdam UMC, Amsterdam, the Netherlands.
JAMA Netw Open. 2024 Jan 2;7(1):e2350765. doi: 10.1001/jamanetworkopen.2023.50765.
IMPORTANCE: Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence to improve hip fracture care regarding the surgical approach of hemiarthroplasty is lacking. OBJECTIVE: To compare 6-month outcomes of the posterolateral approach (PLA) and direct lateral approach (DLA) for hemiarthroplasty in patients with acute femoral neck fracture. DESIGN, SETTING, AND PARTICIPANTS: This multicenter, randomized clinical trial (RCT) comparing DLA and PLA was performed alongside a natural experiment (NE) at 14 centers in the Netherlands. Patients aged 18 years or older with an acute femoral neck fracture were included, with or without dementia. Secondary surgery of the hip, pathological fractures, or patients with multitrauma were excluded. Recruitment took place between February 2018 and January 2022. Treatment allocation was random or pseudorandom based on geographical location and surgeon preference. Statistical analysis was performed from July 2022 to September 2022. EXPOSURE: Hemiarthroplasty using PLA or DLA. MAIN OUTCOME AND MEASURES: The primary outcome was health-related quality of life 6 months after surgery, quantified with the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L). Secondary outcomes included dislocations, fear of falling and falls, activities of daily living, pain, and reoperations. To improve generalizability, a novel technique was used for data fusion of the RCT and NE. RESULTS: A total of 843 patients (542 [64.3%] female; mean [SD] age, 82.2 [7.5] years) participated, with 555 patients in the RCT (283 patients in the DLA group; 272 patients in the PLA group) and 288 patients in the NE (172 patients in the DLA group; 116 patients in the PLA group). In the RCT, mean EQ-5D-5L utility scores at 6 months were 0.50 (95% CI, 0.45-0.55) after DLA and 0.49 (95% CI, 0.44-0.54) after PLA, with 77% completeness. The between-group difference (-0.04 [95% CI, -0.11 to 0.04]) was not statistically significant nor clinically meaningful. Most secondary outcomes were comparable between groups, but PLA was associated with more dislocations than DLA (RCT: 15 of 272 patients [5.5%] in PLA vs 1 of 283 patients [0.4%] in DLA; NE: 6 of 113 patients [5.3%]) in PLA vs 2 of 175 patients [1.1%] in DLA). Data fusion resulted in an effect size of 0.00 (95% CI, -0.04 to 0.05) for the EQ-5D-5L and an odds ratio of 12.31 (95% CI, 2.77 to 54.70) for experiencing a dislocation after PLA. CONCLUSIONS AND RELEVANCE: This combined RCT and NE found that among patients treated with a cemented hemiarthroplasty after an acute femoral neck fracture, PLA was not associated with a better quality of life than DLA. Rates of dislocation and reoperation were higher after PLA. Randomized and pseudorandomized data yielded similar outcomes, which suggests a strengthening of these findings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04438226.
重要性:老年人髋部骨折是严重的损伤,会导致残疾、更高的发病率和死亡率,以及对医疗保健资源的巨大压力。缺乏高质量的证据来改善关于人工髋关节置换术的髋关节骨折治疗方法。
目的:比较后路入路(PLA)和直接外侧入路(DLA)在急性股骨颈骨折患者中进行人工髋关节置换术的 6 个月结果。
设计、地点和参与者:这项多中心、随机临床试验(RCT)比较了 PLA 和 DLA,同时在荷兰的 14 个中心进行了自然实验(NE)。纳入年龄在 18 岁或以上的急性股骨颈骨折患者,有无痴呆症。需要二次髋关节手术、病理性骨折或多发创伤的患者被排除在外。招募工作于 2018 年 2 月至 2022 年 1 月进行。治疗分配是随机或伪随机的,基于地理位置和外科医生的偏好。统计分析于 2022 年 7 月至 2022 年 9 月进行。
暴露:使用 PLA 或 DLA 进行人工髋关节置换术。
主要结果和测量:主要结果是手术后 6 个月的健康相关生活质量,用 EuroQol 组 5 维度问卷(EQ-5D-5L)来衡量。次要结果包括脱位、跌倒恐惧和跌倒、日常生活活动、疼痛和再次手术。为了提高普遍性,采用了一种新的技术对 RCT 和 NE 进行数据融合。
结果:共有 843 名患者(542 名[64.3%]为女性;平均[标准差]年龄为 82.2[7.5]岁)参与了研究,其中 555 名患者在 RCT 中(283 名在 DLA 组;272 名在 PLA 组),288 名患者在 NE 中(172 名在 DLA 组;116 名在 PLA 组)。在 RCT 中,DLA 组的 6 个月 EQ-5D-5L 效用评分平均为 0.50(95%置信区间,0.45-0.55),PLA 组为 0.49(95%置信区间,0.44-0.54),完成率为 77%。两组间的差异(-0.04[95%置信区间,-0.11 至 0.04])在统计学上和临床上都不显著。大多数次要结果在组间比较是可比的,但 PLA 组比 DLA 组更容易发生脱位(RCT:272 名患者中有 15 名[5.5%]发生在 PLA 组,283 名患者中有 1 名[0.4%]发生在 DLA 组;NE:113 名患者中有 6 名[5.3%]发生在 PLA 组,175 名患者中有 2 名[1.1%]发生在 DLA 组)。数据融合得出的 EQ-5D-5L 效应量为 0.00(95%置信区间,-0.04 至 0.05),PLA 后发生脱位的优势比为 12.31(95%置信区间,2.77 至 54.70)。
结论和相关性:这项 RCT 和 NE 的联合研究发现,在接受急性股骨颈骨折后进行骨水泥人工髋关节置换术的患者中,PLA 与 DLA 相比,并不会改善生活质量。PLA 组的脱位和再次手术发生率较高。随机和伪随机数据得出的结果相似,这表明这些发现得到了加强。
试验注册:ClinicalTrials.gov 标识符:NCT04438226。
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