Institute for Musculoskeletal Health, King George V Building, Royal Prince Alfred Hospital, The University of Sydney, Sydney, New South Wales, Australia
Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, Australia.
BMJ Open. 2022 Sep 21;12(9):e064478. doi: 10.1136/bmjopen-2022-064478.
Hip fractures treated with total hip arthroplasty (THA) are at high risk of prosthesis instability, and dislocation is the most common indication for revision surgery. This study aims to determine whether dual mobility THA implants reduce the risk of dislocation compared with conventional THA in patients with hip fracture suitable to be treated with THA.
This is a cluster-randomised, crossover, open-label trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will comprise hospitals that perform at least 12 THAs for hip fracture per annum. All adults age ≥50 years who meet the Australian and New Zealand Hip Fracture Registry guidelines for THA will be included. The intervention will be dual mobility THA and the comparator will be conventional THA. Each hospital will be allocated to two consecutive periods, one of dual mobility THA and the other of conventional THA in random order, aiming for an average of 16 patients eligible for the primary analysis per group (32 total per site), allowing different recruitment totals between sites. Data will be collected through the AOANJRR and linked with patient-level discharge data acquired through government agencies. The primary outcome is dislocation within 1 year. Secondary outcomes include revision surgery for dislocation and all-cause, complications and mortality at 1, 2 and 5 years. If dual mobility THA is found to be superior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 1536 patients from at least 48 hospitals over 3 years.
Ethics approval has been granted (Sydney Local Health District - Royal Prince Alfred Hospital Zone (approval X20-0162 and 2020/ETH00680) and site-specific approvals). Participant recruitment is via an opt-out consent process as both treatments are considered accepted, standard practice. The trial is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.
ACTRN12621000069853.
接受全髋关节置换术（THA）治疗的髋部骨折患者存在假体不稳定的高风险，脱位是翻修手术最常见的指征。本研究旨在确定对于适合接受 THA 治疗的髋部骨折患者，双动髋关节假体与传统 THA 相比是否降低了脱位风险。
这是一项在澳大利亚骨科协会全国关节置换登记处（AOANJRR）内嵌套的集群随机、交叉、开放标签试验。集群将由每年至少进行 12 例髋部骨折 THA 的医院组成。所有符合澳大利亚和新西兰髋部骨折登记处 THA 指南的 50 岁以上成年人都将被纳入。干预措施将是双动髋关节，对照组将是传统 THA。每个医院将被随机分配到两个连续的时期，一个时期是双动髋关节，另一个时期是传统 THA，平均每个组有 16 名符合主要分析条件的患者（每个地点总共 32 名），允许不同的招募总数。数据将通过 AOANJRR 收集，并与通过政府机构获得的患者水平出院数据进行关联。主要结局是 1 年内脱位。次要结局包括脱位的翻修手术以及 1、2 和 5 年时的所有原因、并发症和死亡率。如果发现双动髋关节具有优势，将进行成本效益分析。该研究将在 3 年内招募至少 48 家医院的 1536 名患者。
已获得伦理批准（悉尼地方卫生区-皇家阿尔弗雷德王子医院区（批准 X20-0162 和 2020/ETH00680）和特定地点的批准）。参与者的招募是通过选择退出同意的过程，因为两种治疗方法都被认为是可接受的、标准的治疗方法。该试验得到了澳大利亚和新西兰肌肉骨骼临床研究网络的认可。
ACTRN12621000069853。
