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

• 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
• 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

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 两种常见的上肢损伤的管理，小儿媒体上co骨骨折（MEF） 远端半径骨折（DRF）具有高实践变化是有争议的。辩论很大程度上 重点是减少这些伤害以恢复其通常的位置或使骨折愈合 他们的受伤位置简单固定。观察性研究支持还原和简单 MEF和DRF固定。在这两种伤害中，几乎没有前瞻性和随机研究 评估他们的治疗。鉴于实践中的宽度变化，儿童要么正在经历 当外科医生选择减少麻醉/有意识时，不必要的程序和麻醉事件 镇静或被简单固定化的不足。两种情况都无法接受，因为 面临麻醉风险和额外的成本或与潜在长期功能残疾的不良对准 为了解决这种临床困境，肌肉骨骼小儿急性护理临床的基础设施 组织了试验（IMPACCT）财团，以发展基础设施和经验 多中心随机临床试验。 Impacct的领导能力在领导多中心临床试验方面具有专业知识 及其成员代表北美小儿骨科学会的32个潜水员中心 （posna）。在IMPACCT共识会议期间，参与者同意MEF和DRF具有 必要的设备是最紧迫的临床争议。来自 英国将这些问题确定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治疗变化以及外科医生随机进行随机的意愿。 需要MEF和DRF儿童的多中心随机优势试验来评估 在麻醉/镇静下与简单固定化的临床有效性。中心假设 该提议的是，在全身麻醉（MEF）或有意识的镇静下减少治疗的儿童 （DRF）与用简单固定治疗的患者报告的结果评分更高 独自的。对这两种裂缝的试验都将仅仅是为了利用规模经济和 在解剖位置，结果度量以及是否需要干预方面相似。三十- 根据务实 协议。调查人员已经与试用创新网络合作，以提高试验的效率 开发和执行。尼亚姆斯（Niams）已授予该计划的R34临床试验计划补助金。这 提案将在招募，治疗和遵循患者时以及何时支持主动研究阶段 结果进行分析和传播。 这些试验的完成将为未来提供框架，基础架构和经验 小儿骨科的前瞻性多中心临床试验作为结果指导临床决策。