Perry Daniel C, Achten Juul, Mason James, Kounail Daphne, Nicolaou Nicolas, Metcalfe David, Lyttle Mark, Tutton Elizabeth, Appelbe Duncan, Gibson Phoebe, Costa Matthew L
University of Liverpool, Liverpool, UK.
Oxford Trauma and Emergency Care (OxTEC), Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.
Bone Jt Open. 2025 May 23;6(5):560-568. doi: 10.1302/2633-1462.65.BJO-2024-0260.
The remarkable capacity for distal radius fractures in children to remodel raises questions about the necessity and extent of the intervention required to achieve anatomical alignment. The British Society of Children's Orthopaedic Surgery prioritized this uncertainty as one of their most important research questions. This is the protocol for a randomized, controlled, multicentre, prospective, noninferiority trial of non-surgical casting versus surgical reduction for severely displaced fractures of the distal radius in children: the Children's Radius Acute Fracture Fixation Trial.
Children aged four to ten years old inclusive, who have sustained a severely displaced distal radius fracture, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score, pain measured using the Wong-Baker FACES Pain Scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger participants will be collected. Each patient will be randomly allocated (1:1), stratified using a minimization algorithm by centre, fracture type at presentation (completely off-ended or incompletely off-ended), fracture location (metaphyseal or physeal), and age group (four to six years or seven to ten years) to either a regimen of non-surgical casting or surgical reduction.
At six weeks, and three, six, and 12 months, data on function, pain, QoL, cosmesis, and satisfaction with care will be collected. After completion of the main phase of the study, patients will be followed up for a further two years. Up to one year after randomization, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the PROMIS Upper Extremity Score at three months post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardians.
儿童桡骨远端骨折具有显著的重塑能力，这引发了关于实现解剖复位所需干预的必要性和程度的问题。英国儿童矫形外科学会将这种不确定性列为其最重要的研究问题之一。这是一项针对儿童桡骨远端严重移位骨折的非手术石膏固定与手术复位的随机、对照、多中心、前瞻性、非劣效性试验方案：儿童桡骨急性骨折固定试验。
年龄在4至10岁（含）且发生桡骨远端严重移位骨折的儿童有资格参与。将收集使用患者报告结局测量信息系统（PROMIS）上肢评分的基线功能、使用面部表情疼痛量表测量的疼痛以及使用针对年轻参与者的欧洲五维健康量表评估的生活质量（QoL）。每位患者将通过中心、就诊时的骨折类型（完全离端或不完全离端）、骨折位置（干骺端或骨骺端）和年龄组（4至6岁或7至10岁）使用最小化算法进行分层随机分配（1:1），分为非手术石膏固定方案或手术复位方案。
在6周、3个月、6个月和12个月时，将收集关于功能、疼痛、生活质量、美容效果和护理满意度的数据。在研究的主要阶段完成后，患者将再随访两年。在随机分组后长达1年的时间里，将收集主要结局以及关于并发症、资源使用和缺课的数据。主要结局是随机分组后3个月时的PROMIS上肢评分。所有数据将通过参与者和/或父母/监护人填写的电子问卷获得。
