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 members represent 30 diverse centers from the Pediatric Orthopaedic Society of North America (POSNA) with experience in clinical research and treating fractures. IMPACCT is led and organized by three surgeons (JAJ, JGW, AWH) and an administrative lead (JKB) with expertise with leading multicenter clinical trials. Investigators have partnered with the Trial Innovation Network on key services to increase the efficiency of trial development and execution. Those key services are data management, study monitoring, and single IRB administration. Additionally, the TIN has provided trial administrative mentorship to the study team in return for the opportunity to research e-consent processes during the study period. The goal of their research will be to evaluate e-consent in order to expand its use for future trials. The aim of this proposal is to determine if functional outcome scores (PROMIS) in operatively treated MEF and sedated DRF are higher, compared to those treated with immobilization alone. 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 cast management alone.
|Effective start/end date
|9/1/21 → 8/31/26
- Ann & Robert H. Lurie Children’s Hospital of Chicago (901634-NORTHWESTERN AMD02 // 5U01AR079113-03)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (901634-NORTHWESTERN AMD02 // 5U01AR079113-03)
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