IMPACCT – Infrastructure for Musculoskeletal Pediatric Acute Care Clinical Trials

Twenty percent of children will experience a fracture involving the upper extremity. While there is consensus on how to treat many injuries, the management of pediatric medial epicondyle fractures (MEF) and displaced distal radius fractures (DRF) have great controversy resulting in 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 without 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. The purpose of this application is to complete the administrative 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 quality and data management plan, and case report forms, identify sites for subject recruitment, implement standardized agreements and complete the central IRB process, and develop a recruitment and retention plan and conduct model recruitment to test feasibility. We have engaged the Trial Innovation Network for partnership on several of these key services to accelerate trial development. 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 priority questions to answer with the proposed trials. These two conditions have been debated in orthopaedic surgery without consensus and without adequate data to guide clinical decision making. 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.