IMPACCT: Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

IMPACCT：肌肉骨骼儿科急性护理临床试验的基础设施

基本信息

批准号：
10477229
负责人：
Joseph A Janicki
金额：
$ 144万
依托单位：
LURIE CHILDREN'S HOSPITAL OF CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2026-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10477229
关键词：
Address Affect American Anatomy Anesthesia procedures Anesthetics Area Award Child Childhood Childhood Injury Client satisfaction Clinical Clinical Research Clinical Trials Clinical effectiveness Complication Conscious Sedation Consensus Data Coordinating Center Development Distal Equipoise Event Face Fracture Future General Anesthesia General anesthetic drugs Grant Immobilization Infrastructure Injury Intervention Lead Leadership Location Medial Medicine Methods Modeling Morbidity - disease rate Multi-Institutional Clinical Trial Musculoskeletal National Institute of Arthritis and Musculoskeletal and Skin Diseases North America Observational Study Operative Surgical Procedures Orthopedic Surgery Orthopedics Outcome Measure Pain Participant Patient Outcomes Assessments Patient Recruitments Patients Phase Positioning Attribute Procedures Protocols documentation Radius Fractures Randomized Randomized Clinical Trials Randomized Controlled Trials Reporting Research Research Personnel Risk Savings Sedation procedure Site Societies Surgeon Surveys TimeLine United Kingdom Unnecessary Procedures Upper Extremity Upper Extremity Fracture Variant Voting acute care bone bone healing clinical decision-making clinical practice cost disability experience functional disability functional outcomes healing injured innovation limb injury member operation pediatric trauma primary outcome procedure cost prospective recruit secondary outcome sedative symposium trauma care treatment strategy willingness

项目摘要

ABSTRACT The management of two common upper extremity injuries, pediatric medial epicondyle fractures (MEF) and displaced distal radius fractures (DRF), is controversial with high practice variation. The debate largely focusses on whether to reduce these injuries to restore their usual position or to allow the fractures to heal in their injured position with simple immobilization. Observational studies support both reduction and simple immobilization for MEF and DRF. In both injuries, there have been few prospective and no randomized studies evaluating their treatment. Given the widespread variation in practice, children are either undergoing unnecessary procedures and anesthetic events when surgeons opt for reduction under anesthesia/ conscious sedation OR are being undertreated by simple immobilization. Both scenarios are unacceptable in that children face either anesthetic risks and extra costs or poor alignment with potential long term functional disability To address such clinical dilemmas, the Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials (IMPACCT) consortium was organized to develop the infrastructure and experience necessary for multicenter randomized clinical trials. IMPACCT’s leadership has expertise in leading multicenter clinical trials and its members represent 32 diverse centers from the Pediatric Orthopaedic Society of North America (POSNA). During the IMPACCT Consensus Conference, participants agreed that that MEF and DRF have the equipoise necessary and are the most pressing clinical controversies. A similar priority-setting study from the United Kingdom identified these questions as important controversies in children’s orthopaedic surgery. POSNA-wide surveys confirmed MEF and DRF treatment variation and surgeons’ willingness to randomize. A multicenter randomized superiority trial of children with MEF and DRF is required to evaluate the clinical effectiveness of reduction under anesthesia/sedation vs. simple immobilization. The central hypothesis of this proposal is that children treated with reduction under general anesthesia (MEF) or conscious sedation (DRF) will have higher patient reported outcome scores compared to those treated with simple immobilization alone. 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. Thirty- one sites have agreed to recruit, randomize and treat a total of 688 patients according to the pragmatic protocols. Investigators have partnered with the Trial Innovation Network to increase the efficiency of trial development and execution. NIAMS has awarded this initiative an R34 Clinical Trials Planning Grant. This proposal will support the active study phase when patients are recruited, treated, and followed and when results are analyzed and disseminated. The completion of these trials will provide a framework, infrastructure and experience for future prospective multicenter clinical trials in pediatric orthopaedics as its results guide clinical decision-making.

抽象的两种常见上肢损伤的治疗：小儿上髁骨折（MEF）和移位的桡骨远端骨折（DRF），由于实践变化很大而存在争议。重点是是否减少这些伤害以恢复其通常的位置或让骨折愈合观察性研究支持复位和简单固定。对于 MEF 和 DRF 的固定，很少有前瞻性研究，也没有随机研究。鉴于实践中存在广泛差异，儿童要么正在接受治疗。当外科医生选择在麻醉/清醒状态下复位时，不必要的手术和麻醉事件镇静或简单固定治疗不足，这两种情况对于儿童来说都是不可接受的。要么面临麻醉风险和额外费用，要么面临潜在的长期功能障碍为了解决此类临床困境，肌肉骨骼儿科急性护理临床基础设施组织试验（IMPACCT）联盟是为了开发必要的基础设施和经验 IMPACCT 的领导层在领先的多中心临床试验方面拥有专业知识。及其成员代表北美小儿骨科协会的 32 个不同中心 (POSNA) 在 IMPACCT 共识会议上，与会者一致认为 MEF 和 DRF 拥有平衡是必要的，也是最紧迫的临床争议。英国将这些问题视为儿童骨科手术中的重要争议。 POSNA 范围内的调查证实了 MEF 和 DRF 治疗的差异以及外科医生随机化的意愿。需要对 MEF 和 DRF 儿童进行多中心随机优势试验来评估麻醉/镇静下复位与简单固定的临床效果中心假设。该提案的主要内容是在全身麻醉（MEF）或清醒镇静下对儿童进行复位治疗与简单固定治疗的患者相比，（DRF）患者报告的结果分数更高两种骨折的试验将同时进行，以利用规模经济和优势。在解剖位置、结果测量以及是否需要干预方面相似。一个站点已同意根据务实原则招募、随机分组并治疗总共 688 名患者研究人员与试验创新网络合作以提高试验效率。 NIAMS 已授予该计划 R34 临床试验规划补助金。该提案将支持积极的研究阶段，即招募、治疗和随访患者，以及结果得到分析和传播。这些试验的完成将为未来提供框架、基础设施和经验儿科骨科前瞻性多中心临床试验，其结果指导临床决策。