BACKGROUND Femoral neck fractures (FNFs), which are common in the older population, are associated with high mortality and morbidity. Some 20% of FNFs are undisplaced (uFNFs). The routine surgical procedure for uFNFs is internal fixation (IF) with 2-3 screws/pins with a reported reoperation rate in older patients (age ≥ 75 years) of up to 21%. The reoperation rate for hemiarthroplasties for displaced fractures is lower than for undisplaced fractures operated with IF. This study will aim to determine whether the outcome for older patients with an uFNF can be improved by replacing the hip instead of preserving it. METHODS A national multicentre, register-based, randomised controlled trial (rRCT) will be conducted. For this trial, 1440 patients, ≥75 years with an acute uFNF, will be allocated. Eligible patients will be identified by the Swedish Fracture Register (SFR) platform, which will notify the admitting orthopaedic surgeon of eligibility. After informed consent has been given and documented, patients will be randomised to either IF (control group) or arthroplasty (intervention group) within the SFR platform. Injury mechanism, fracture classification, date of injury, and type of treatment are registered in the SFR. Type and brand of arthroplasty, surgical approach, and fixation are obtained from the Swedish Hip Arthroplasty Register (SHAR). The study cohort from the SFR will be cross-checked with the National Patient Register and the SHAR for outcome variables at 2, 5, and 10 years. The primary outcome will be a composite variable comprising reoperation rate and mortality at 2 years postoperatively. Secondary endpoints will include reoperation rate and mortality as stand-alone variables. In addition, secondary endpoints will be patient-reported outcomes as measured by the Short Musculoskeletal Functional Assessment questionnaire at 1 year postoperatively as routinely collected within the SFR. Further secondary endpoints will include the occurrence of adverse events such as pneumonia, stroke or myocardial infarction and evaluation of the external validity of the study. DISCUSSION This large, multicentre, register-based randomised controlled trial could potentially shift the treatment of uFNFs in older patients towards primary hip arthroplasty in order to improve the outcome. TRIAL REGISTRATION The trial is registered at www.clinicaltrials.gov (NCT03966716); May 29, 2019.

中文翻译：

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研究方案：HipSTHeR-基于寄存器的随机对照试验-髋螺钉或（全）髋关节置换术治疗老年患者未移位的股骨颈骨折。

背景技术股骨颈骨折（FNF）在老年人群中很常见，与高死亡率和高发病率有关。大约20％的FNF未移位（uFNF）。uFNFs的常规外科手术是使用2-3个螺钉/销进行内固定（IF），据报道，老年患者（年龄≥75岁）的再手术率高达21％。移位骨折的半髋置换的再手术率低于中空手术的未移位骨折。这项研究旨在确定是否可以通过替换髋关节而不是保留髋关节来改善老年uFNF患者的预后。方法将进行一项基于注册的国家多中心随机对照试验（rRCT）。对于该试验，将分配1440名≥75岁的急性uFNF患者。合格的患者将通过瑞典骨折登记（SFR）平台进行识别，该平台将通知入院的骨科医生。在获得知情同意并记录下来后，患者将被随机分配至SFR平台中的IF（对照组）或关节置换术（干预组）。在SFR中记录了损伤机制，骨折分类，受伤日期和治疗类型。人工髋关节置换术的类型和品牌，外科手术方法和固定装置均来自瑞典髋关节置换术注册（SHAR）。来自SFR的研究队列将与美国国家患者登记簿和SHAR进行交叉核对，确定2年，5年和10年的结果变量。主要结果将是一个综合变量，包括术后2年的再手术率和死亡率。次要终点将包括再手术率和死亡率作为独立变量。此外，次要终点是患者报告的结局，如术后1年通过SFR常规收集的短期肌肉骨骼功能评估问卷进行测量。其他次要终点将包括不良事件的发生，例如肺炎，中风或心肌梗塞，以及对研究外部有效性的评估。讨论这项大型，多中心，基于登记的随机对照试验可能将老年患者的uFNFs治疗转向原发性髋关节置换术，以改善预后。试验注册该试验已在www.clinicaltrials.gov（NCT03966716）上注册。2019年5月29日。次要终点是患者报告的结局，如术后1年通过SFR常规收集的短期肌肉骨骼功能评估问卷所测量。其他次要终点将包括不良事件的发生，例如肺炎，中风或心肌梗塞，以及对研究外部有效性的评估。讨论这项大型，多中心，基于登记的随机对照试验可能将老年患者的uFNFs治疗转向原发性髋关节置换术，以改善预后。试验注册该试验已在www.clinicaltrials.gov（NCT03966716）上注册。2019年5月29日。次要终点是患者报告的结局，如术后1年通过SFR常规收集的短期肌肉骨骼功能评估问卷所测量。其他次要终点将包括不良事件的发生，例如肺炎，中风或心肌梗塞，以及对研究外部有效性的评估。讨论这项大型，多中心，基于登记的随机对照试验可能将老年患者的uFNFs治疗转向原发性髋关节置换术，以改善预后。试验注册该试验已在www.clinicaltrials.gov（NCT03966716）上注册。2019年5月29日。