IMPACCT – Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

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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.