Costa Matthew L, Achten Juul, Appelbe Duncan, Athwal Amrita, Grant Richard, Cook Jonathan, Pinedo-Villanueva Rafael, Petrou Stavros, Griffin Xavier L
Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
UK Musculoskeletal Trauma PPI Group, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Bone Jt Open. 2025 Apr 2;6(4):383-390. doi: 10.1302/2633-1462.64.BJO-2024-0240.
Hip fracture is one of the biggest challenges facing patients and healthcare systems. Worldwide, there are currently 1.3 million hip fractures per year, projected to rise to more than six million by 2050. This protocol describes a platform trial framework, designed to efficiently deliver multiple randomized comparisons of interventions for patients with a fragility hip fracture.
All patients aged 60 years and over with a hip fracture presenting to the World Hip Trauma Evaluation (WHiTE) recruitment centres will be considered for eligibility for each of the randomized comparisons appended to the platform at the time of recruitment. They will be offered the opportunity to take part in any or all of the randomized comparisons for which they are eligible. Comparisons may be contemporaneous or distributed throughout the treatment pathway. This master protocol describes the trial procedures, core dataset, and documentation. It describes those components of the research process which will be consistent between randomized comparisons. Where additional procedures are planned, specific to a randomized comparison, these will be described in a separate appendix protocol for that randomized comparison.
The WHiTE platform trial will provide randomized evidence regarding the clinical and cost-effectiveness of interventions to improve outcomes for patients with fragility hip fracture. Findings will inform national and international policy and practice guidelines for the management of patients with a hip fracture.
髋部骨折是患者和医疗系统面临的最大挑战之一。目前全球每年有130万例髋部骨折，预计到2050年将增至600多万例。本方案描述了一个平台试验框架，旨在高效地为脆性髋部骨折患者提供多种干预措施的随机对照比较。
所有60岁及以上因髋部骨折就诊于世界髋部创伤评估（WHiTE）招募中心的患者，在招募时将被考虑是否符合附加在该平台上的每项随机对照比较的资格标准。他们将有机会参与其符合条件的任何或所有随机对照比较。对照可以是同期进行的，也可以分布在整个治疗过程中。本主方案描述了试验程序、核心数据集和文件。它描述了随机对照比较之间研究过程中一致的那些组成部分。如果计划了特定于某一随机对照比较的额外程序，将在该随机对照比较的单独附录方案中进行描述。
WHiTE平台试验将提供关于干预措施临床和成本效益的随机证据，以改善脆性髋部骨折患者的预后。研究结果将为髋部骨折患者管理的国家和国际政策及实践指南提供参考。
