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.

抽象的 百分之二十的儿童会出现上肢骨折。儿科内侧 上髁骨折（MEF）和移位的桡骨远端骨折（DRF）是两种常见的损伤 争论没有达成共识，也没有足够的证据来指导临床决策。这种缺乏 证据导致骨科医生之间的实践存在很大差异。争论的焦点是是否要重新调整 这些损伤恢复到原来的解剖位置或让骨折碎片在当前的状态下愈合 具有石膏固定且没有正式复位的位置。观察性研究支持手术和 MEF 的非手术治疗。对于 DRF，传统的解剖或近解剖重新排列策略 最近的研究报告了相同的结果，但没有正式减少，因此受到质疑。在两者中 在这种情况下，很少有前瞻性研究评估这些特定骨折的治疗方法。到 为了解决这些重要的临床难题，随机临床试验是必要的。对两种骨折的试验将 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 临床试验以确定未手术降低的 MEF 和 DRF 的功能评分是否与那些相似 减量治疗。我们已经建立了肌肉骨骼儿科急性护理临床基础设施 试验 (IMPACCT) 联盟致力于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 多个地点的儿科骨科医生组成， 该小组一致认为，这两种骨折是需要优先考虑的最重要的创伤状况 以获得资金。 此应用程序的目的是完成必要的管理和运营活动 试验成功完成。在资助期间，我们将开发基础设施以完成 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， 确定受试者招募地点，实施标准化协议，完成中央 IRB 流程， 制定招聘和保留计划并进行模型招聘以测试招聘可行性。我们 已与试验创新网络就其中几项关键服务建立合作伙伴关系，以加速试验 发展。试点创新网还将利用模型招募期，在使用上进行创新 知情同意过程中的技术。 在药品成本受到严格审查的时代，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提供经验。