Dual mobility versus standard cups in total hip replacement for displaced femoral neck fractures (Duality): an international, multicentre, randomised, controlled, superiority trial.

Dual mobility total hip replacement (DM-THR) was developed to increase joint stability, but no randomised trial has investigated its efficacy and safety.

双动全髋关节置换术（DM-THR）被开发出来以增加关节稳定性，但尚无随机试验研究其疗效和安全性。

We aimed to compare the risk of dislocation in patients receiving DM-THR versus conventional THR.

我们旨在比较接受数字化制造全髋关节置换术（DM-THR）与传统全髋关节置换术（THR）患者的脱位风险。

Methods

We included people aged 65 years or older with a displaced femoral neck fracture attending 20 Swedish and 24 UK hospitals in this pragmatic, registry-based, randomised superiority trial. Participants eligible for THR were randomly allocated in a 1:1 ratio to either DM-THR or standard THR with the use of remote, web-based, country-specific sequences.

我们纳入了年龄在65岁或以上的患者，这些患者有移位的股骨颈骨折，在20家瑞典医院和24家英国医院参加这项实用的、基于注册的、随机优越性试验。符合全髋关节置换术（THR）条件的参与者以1:1的比例随机分配到数字化制造全髋关节置换术（DM-THR）或标准 THR，使用远程、基于网络的、特定于国家的序列。

Neither participants nor members of the direct clinical care teams were masked, but research investigators and statisticians were masked until the trial analysis was completed.

既没有参与者也没有直接临床护理团队的成员被蒙蔽，但研究调查员和统计学家在试验分析完成之前被蒙蔽。

The primary outcome was dislocation of the index joint, treated with closed reduction or open surgery within 1 year, analysed in the modified intention-to-treatpopulation including all consenting participants receiving any type of hip replacement and excluding those with major protocol deviations.

主要结果是索引关节脱位，在1年内用闭合复位或开放手术治疗，分析了包括所有接受任何类型髋关节置换并排除了有重大方案偏差的同意参与者在内的修改意向治疗人群。

This trial is registered with ClinicalTrials.gov (NCT03909815) and ISRCTN11895196.

该试验已在ClinicalTrials.gov (NCT03909815)和ISRCTN11895196上注册。

Results

Between Jan 9, 2020, and April 2, 2024, 2934 eligible patients were screened, of whom 1334 were not enrolled, mainly due to surgeon's preference (n=560), because they had already been treated at the time of screening (n=257), or because informed consent was not obtained (n=213). 1600 participants (64% female, 36% male) were thus randomly assigned to either DM-THR (n=798) or THR (n=802).

在2020年1月9日至2024年4月2日期间，共有2934名符合条件的患者接受了筛查，其中1334名未被纳入研究，主要原因包括外科医生的偏好（n=560），筛查时已经接受过治疗（n=257），或者未获得知情同意（n=213）。因此，1600名参与者（女性占64%，男性占36%）被随机分配到DM-THR组（n=798）或THR组（n=802）。

After exclusion of 34 participants due to prespecified protocol deviations, 1566 participants (97·9%) contributed to the modified intention-to-treatanalysis.

在排除了34名因预设的方案偏差而退出的参与者后，1566名（97.9%）参与者对修改后的意向治疗分析做出了贡献。

A dislocation, the primary outcome, occurred in ten (1·3%) of 779 participants in the DM-THR group and in 33 (4·2%) of 787 in the THR group (adjusted hazard ratio0·27, 95% CI 0·13-0·56; p<0·0001).

脱位，主要结果，在779名DM-THR组的参与者中有十名（1.3%）发生，在787名THR组的参与者中有33名（4.2%）发生（调整后的风险比为0.27，95%置信区间为0.13-0.56；p<0.0001）。

interpretation

The use of DM-THR substantially reduced the risk of dislocation and of any surgical complication among people treated with THR after a displaced femoral neck fracture.

DM-THR 的使用显著降低了接受 THR 治疗的股骨颈骨折后移位患者的脱位风险和任何手术并发症的风险。

DM-THR can thus be recommended for this group of patients.

因此，可以推荐 DM-THR 用于这一患者群体。

funding

The Swedish Research Council and the National Institute for Health and Care Research.

瑞典研究理事会和国家健康与护理研究院。