IMPACCT – Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

摘要 20%的儿童会经历上肢骨折。儿科医学 上髁骨折（MEF）和桡骨远端移位骨折（DRF）是两种常见的损伤， 没有达成共识，没有足够的证据来指导临床决策。这种缺乏 有证据表明，整形外科医生之间的实践差异很大。争论的焦点是， 这些损伤恢复到原来的解剖位置或允许骨折碎片在当前位置愈合 石膏固定的位置，没有正式的复位。观察性研究支持手术和 MEF的非手术治疗。对于DRF，解剖或近解剖重新对线的传统策略 最近的研究报告了没有正式减少的等效结果。无论是 例，很少有前瞻性研究评价这些特定骨折的治疗。到 为了解决这些重要的临床难题，随机临床试验是必要的。两处骨折的试验 同时进行，以利用规模经济，并且在解剖学方面相似 位置、结果测量以及是否需要干预。我们建议随机多中心 临床试验，以确定手术未复位MEF和DRF的功能评分是否与 治疗减少。我们已经建立了肌肉骨骼儿科急症护理临床基础设施 IMPACCT是一个多中心随机临床试验联盟，旨在开发多中心随机临床试验所需的基础设施。 IMPACCT由来自北美30多个地点的儿科整形外科医生组成， 该小组一致认为这两种骨折是应优先考虑的最重要的创伤情况 资金。 本申请的目的是完成必要的行政和业务活动， 成功完成试验。在拨款期内，我们会发展基建设施， 计划的试验，包括操作程序手册、数据管理计划和病例报告表， 确定受试者招募的研究中心，实施标准化协议，完成中心IRB流程， 制定招聘和留用计划，并进行示范招聘，以测试招聘的可行性。我们 我已经与试验创新网络就其中几项关键服务建立了合作伙伴关系，以加快试验 发展试验创新网络还将利用模型招募期，在使用 知情同意过程中的技术。 在一个医药费用受到严格审查的时代，可以通过避免 不必要的程序。这些试验的最终完成将提供框架、基础设施和 为未来儿科骨科前瞻性多中心临床试验积累经验。

ABSTRACT Twenty percent of children will experience a fracture involving the upper extremity. Pediatric medial epicondyle fractures (MEF) and displaced distal radius fractures (DRF) are two common injuries which are debated without consensus and without adequate evidence to guide clinical decision making. This lack of evidence has led to high practice variation among orthopaedic surgeons. The debate is whether to realign these injuries to their original anatomic position or to allow the fracture fragments to heal in their current positions with cast immobilization and no formal reduction. Observational studies support both operative and non-operative management for MEF. For DRF, traditional strategies of anatomic or near anatomic realignment have come into question with recent studies reporting equivalent results without formal reduction. In both cases, there have been few prospective studies evaluating the treatment of these specific fractures. To address these important clinical dilemmas, randomized clinical trials are necessary. Trials on both fractures will be conducted simultaneously to take advantage of the economy of scale and are similar in terms of anatomic location, outcome measures, and whether an intervention is necessary. We propose randomized, multicenter clinical trials to determine if the functional scores of operatively unreduced MEF and DRF are similar to those treated with reduction. We have formed the Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT) consortium to develop the infrastructure necessary for multicenter randomized clinical trials. IMPACCT consists of pediatric orthopaedic surgeons from more than 30 sites across North America and it is the consensus of this group that these two fractures are the most important trauma conditions to be prioritized for funding. The purpose of this application is to complete the administrative and operational activities necessary for successful trial completion. During the funding period, we will develop the infrastructure to complete the planned trial including the manual of operating procedures, the data management plan, and case report forms, identify sites for subject recruitment, implement standardized agreements, complete the central IRB process, and develop a recruitment and retention plan and conduct model recruitment to test recruitment feasibility. We have engaged the Trial Innovation Network for partnership on several of these key services to accelerate trial development. The Trial Innovation Network will also use the model recruitment period to innovate on the use of technology in the informed consent process. In an era when the cost of medicine is being scrutinized, savings can be achieved by avoiding the unnecessary procedures. The ultimate completion of these trials will provide framework, infrastructure and experience for future prospective multicenter clinical trials in pediatric orthopaedics.