Hand fractures are common and sometimes require surgery to restore function. Placement of Kirschner wires (K-wires) is the most common form of surgical fixation. After placement, a key decision is whether to bury the end of a K-wire or leave it protruding from the skin (exposed). A recent systematic review found no evidence to support either approach and a national clinician and surgeon survey demonstrated further uncertainty. We aim to determine the design of a definitive randomised controlled trial assessing the cost and clinical effectiveness of buried versus exposed Kirschner wires for adults with metacarpal or phalangeal fractures. We will employ three methodologies: a national service evaluation of current clinical practice, patient and surgeon focus groups and a consensus meeting to finalise the protocol for a randomised controlled trial. For the service evaluation, all outcomes will be summarised using descriptive statistics overall and split by group (buried versus exposed K-wires). Information collected in the patient focus groups will be analysed thematically. The surgeon consensus meeting will address each part of the design in turn and through discussion agree a final protocol. The study may be monitored, or audited in accordance with the current approved protocol, Good Clinical Practice (GCP), relevant regulations and standard operating procedures. The Chief Investigator will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. A feasibility study report will be published by the Wire Study Steering committee. Additional members of the steering group and citable collaborators will be listed within the manuscript and their roles identified.

中文翻译：

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钢丝研究——评估英国手部骨折克氏针固定的多阶段可行性研究方案

手部骨折很常见，有时需要手术才能恢复功能。放置克氏针（克氏针）是最常见的手术固定形式。放置后，关键的决定是是否埋入克氏针末端或使其从皮肤中突出（暴露）。最近的一项系统审查发现没有证据支持这两种方法，而全国临床医生和外科医生的调查则显示出进一步的不确定性。我们的目的是确定一项明确的随机对照试验的设计，以评估埋藏克氏针与暴露克氏针治疗成人掌骨或指骨骨折的成本和临床效果。我们将采用三种方法：对当前临床实践的全国服务评估、患者和外科医生焦点小组以及最终确定随机对照试验方案的共识会议。对于服务评估，所有结果将使用描述性统计数据进行总体总结并按组划分（埋藏克氏针与暴露克氏针）。将按主题分析在患者焦点小组中收集的信息。外科医生共识会议将依次讨论设计的每个部分，并通过讨论达成最终方案。可以根据当前批准的方案、良好临床实践（GCP）、相关法规和标准操作程序对研究进行监测或审核。对原批准文件的所有重大修改，首席研究员将提交并在必要时获得上述各方的批准。可行性研究报告将由电线研究指导委员会发布。指导小组的其他成员和可引用的合作者将在手稿中列出，并确定他们的角色。