The COMET Study

About the Study

The COMET Study is being led by the Division of Orthopaedic Surgery at Ann & Robert H. Lurie Children’s Hospital of Chicago along with the Infrastructure for Musculoskeletal Pediatric Acute Care Trials (IMPACCT) consortium.

Study locations

  • IWK Health Centre
  • The Hospital for Sick Children

  • Boston Children’s Hospital
  • Rutgers University
  • New York University Grossman School of Medicine
  • Albert Einstein College of Medicine
  • Hospital for Special Surgery
  • University of Rochester
  • Nemours Alfred I. duPont Hospital for Children
  • Geisinger Medical Center
  • Rhode Island Hospital

  • Duke University
  • All Children's Johns Hopkins
  • The University of North Carolina at Chapel Hill
  • Mississippi Children's Hospital
  • Children’s Hospital New Orleans
  • Nicklaus Miami Children's

  • The University of Texas Southwestern Medical Center / Texas Scottish Rite Hospital for Children
  • Phoenix Children’s Hospital
  • Baylor College of Medicine/Texas Children's Hospital
  • UNM Carrie Tingley

  • Children’s Hospital Los Angeles
  • Children’s Hospital Colorado
  • The Regents of University of California, Los Angeles
  • Board of Trustees of the Leland Stanford Junior University
  • Oregon Health & Science University
  • Seattle Children's Hospital

  • Ann & Robert H. Lurie Children's Hospital
  • Gillette Children’s Specialty Healthcare / Children’s Minnesota
  • Indiana University / Riley Children's Hospital
  • Cincinnati Children’s Hospital Medical Center
  • Case Western Reserve University / Rainbow Babies
  • HealthPartners Institute / TRIA
  • The Children’s Hospital of Philadelphia
  • Johns Hopkins Medicine
  • Northwestern University
  • The University of Iowa

Information about the Study

Study Design

COMET is a multicenter, prospective randomized superiority trial of medial epicondyle fracture treatments.

Treatments

Operative reduction and fixation -OR- non-operative immobilization of pediatric medial epicondyle fractures.

Things to Know

Despite studies of medial epicondyle fracture dating back more than 200 years, doctors are not sure which treatment is better.

PROMIS

The primary outcome measure to be used is the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children Computer Adaptive Test at 12 months post-randomization

Participant Data

Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be transmitted to and stored at the Duke Clinical Research Institute (DCRI).

Study Funders

The study is funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Principal Investigators

Joseph Janicki, MD MS

Joseph Janicki, MD, MS, (Principal Investigator) is an Associate Professor of Orthopaedic Surgery at Northwestern University and has an MS in Clinical Investigation (Northwestern). Dr. Janicki is a surgeon-scientist whose research includes bone health in children, hip dysplasia and multicenter research (4 topic specific study groups). He is currently the PI of a 19 site PROOF trial examining children’s open fracture treatment. Dr. Janicki will serve as the PI for the IMPACCT study and will be responsible for study protocols, funding, and management.

Jamie Burgess, PhD.

Jamie Burgess, PhD, (Co-Investigator) is a Research Assistant Professor at Northwestern University whose research focuses on increasing efficiency in multicenter trials in pediatric orthopaedics, operationalizing informed consent and evaluating educational tools for clinical research. She has served as the lead research manager on two multicenter, international studies in pediatric orthopaedics.

Collin May, MD MPH, Boston’s Children’s, COMET Lead Investigator

Collin May is the lead investigator on the IMPACCT-MEF protocol. He is a pediatric orthopaedic surgeon at Boston Children’s Hospital, where he treats pediatric trauma and limb deformities. He recently completed a master’s degree in Public Health with a focus on clinical effectiveness.

Study Team

The research team for the COMET study has a lot of experience in caring for patients with fracture injuries and are active in health research.

Jacob Wild, BS

Jacob Wild is a Clinical Research Professional. He has worked with the Division of Orthopaedic Surgery at Ann & Robert H. Lurie Children’s Hospital of Chicago since 2015. His efforts have primarily been associated with pediatric sports specialization and concussion. He will be supporting the IMPACCT Consortium. In his spare time, he enjoys scuba diving, skiing, and playing golf.

Lauren Spirov, MS BS

Lauren has been with Lurie Children’s for three years and supports both Sports Medicine studies and Orthopedic studies. She primarily supports knee injury studies and is the program coordinator for the Institute of Sports Medicine Knee Injury Prevention Program (KIPP).

Daniel McBride, BS

Daniel McBride is a Clinical Research Coordinator I at Lurie Children’s Hospital of Chicago under the Department of Orthopaedic Surgery and Sports Medicine. He supports the research studies of 5 physician investigators. In his spare time, he enjoys powerlifting, Brazilian jiu-jitsu, guitar, and enjoying different foods around the city of Chicago.

Delanie Rybacki, BS

Delanie is a clinical research coordinator, working on multiple studies, including IMPACCT. She has been a part of the Lurie Children’s team since March of 2022. Outside of work, Delanie enjoys running, spending time at the lake, and exploring new restaurants in the Chicago area.

Candace Young, BS

Candace is the Project Manager for IMPACCT within the Division of Orthopaedic Surgery and Sports Medicine at Ann & Robert Children’s Hospital of Chicago since June 2022. She is an advocate for increasing minority participation in clinical research to address health disparities within research. In her spare time, she enjoys exploring a variety of cultural restaurants in Chicago, listening to music/attending music festivals, and traveling.