IMPACCT – Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

IMPACCT — 肌肉骨骼儿科急性护理临床试验基础设施

• 批准号: 9977922
• 负责人: Joseph A Janicki
• 金额: $ 14.21万
• 依托单位: LURIE CHILDREN'S HOSPITAL OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-15 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9977922
• 关键词: Address; Affect; Agreement; Anatomy; Anesthesia procedures; Award; Back; Case Report Form; Child; Childhood; Childhood Injury; Clinical; Clinical Research; Clinical Trials; Consensus; Data; Development; Distal; Equipoise; Fracture; Funding; Future; Grant; Human Resources; Immobilization; Informed Consent; Infrastructure; Injury; Institutional Review Boards; Intervention; Lead; Location; Manuals; Medial; Medicine; Methods; Modeling; Monitor; Multi-Institutional Clinical Trial; Musculoskeletal; North America; Observational Study; Orthopedic Surgery procedures; Orthopedics; Outcome Measure; Participant; Patients; Positioning Attribute; Procedures; Process; Prospective Studies; Radius Fractures; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research Personnel; Risk; Safety; Sample Size; Savings; Services; Site; Societies; Standardization; Surgeon; Surveys; Technology; Testing; Training; Trauma; Unnecessary Procedures; Upper Extremity; Variant; Voting; acute care; bone; clinical decision-making; common treatment; cost; data management; disability; experience; functional disability; healing; innovation; limb injury; member; procedure cost; prospective; recruit; symposium; willingness

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.

摘要 20%的儿童将经历涉及上肢的骨折。儿科内科 上髁骨折(MEF)和移位的桡骨远端骨折(DRF)是两种常见的损伤， 辩论没有达成共识，也没有足够的证据来指导临床决策。这种缺乏 有证据表明，骨科医生之间的实践差异很大。争论的焦点是是否重新调整 这些损伤恢复到原来的解剖位置，或者让骨折碎片在目前的状态下愈合 有石膏固定的位置，没有正式的减少。观察性研究同时支持手术和 MEF的非手术治疗。对于DRF，传统的解剖或近解剖重排策略 最近的研究报告在没有正式减少的情况下取得了同等的结果，这一点受到了质疑。在这两个地方 但是，对于这些特殊骨折的治疗，很少有前瞻性的研究。至 要解决这些重要的临床难题，随机临床试验是必要的。对这两个骨折的试验将 同时进行，以利用规模经济，在解剖方面相似 地点、结果衡量标准以及是否有必要进行干预。我们建议随机、多中心 临床试验以确定手术未复位的MEF和DRF的功能评分是否与 用还原处理的。我们已经形成了肌肉骨骼儿科急救临床基础设施 试验(IMPACCT)联盟，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，它是 这组人的共识是，这两个骨折是最重要的创伤情况，需要优先处理 为了资金。 此应用程序的目的是完成以下所需的管理和操作活动 已成功完成试运行。在资助期内，我们会发展基建，以完成 计划审判，包括操作程序手册、数据管理计划和案件报告表； 确定科目招聘地点，执行标准化协议，完成中央内部审查委员会流程， 并制定招聘和留住计划，并进行模型招聘，以检验招聘的可行性。我们 我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。试创网还将利用模式招聘期，对使用 技术在知情同意过程中的作用。 在一个药品成本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 儿科骨科未来多中心临床试验的经验。