{
  "abstract": "Introduction Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.Methods and analysis Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).Ethics and dissemination Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.Trial registration number NCT05131685.",
  "authors": [
    {
      "affiliations": [
        "Biostatistics Collaboration Center and Northwestern University Data Analysis and Coordinating Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA"
      ],
      "name": "Lauren Balmert Bonner"
    },
    {
      "affiliations": [
        "Division of Orthopaedics & Sports Medicine, Ann and Robert H Lurie Children’s Hospital of Chicago, Chicago, Illinois, USA"
      ],
      "name": "Joseph Janicki"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Gillette Children's Specialty Healthcare, Saint Paul, Minnesota, USA"
      ],
      "name": "Andrew Georgiadis"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Gillette Children's Specialty Healthcare, Saint Paul, Minnesota, USA"
      ],
      "name": "Walter Truong"
    },
    {
      "affiliations": [
        "Orthopedics and Sports Medicine, Texas Children’s Hospital, Houston, Texas, USA"
      ],
      "name": "Dorothy Harris Beauvais"
    },
    {
      "affiliations": [
        "Orthopedic Surgery and Sports Medicine, Phoenix Children’s Hospital, Phoenix, Arizona, USA"
      ],
      "name": "Mohan Belthur"
    },
    {
      "affiliations": [
        "Pediatric Orthopedic Surgery, Riley Hospital for Children, Indianapolis, Indiana, USA"
      ],
      "name": "Erika L Daley"
    },
    {
      "affiliations": [
        "Department of Orthopedics, Nemours Children's Hopistal, Wilmington, Delaware, USA"
      ],
      "name": "Jeanne Franzone"
    },
    {
      "affiliations": [
        "Division of Orthopaedic Surgery, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada"
      ],
      "name": "Andrew Howard"
    },
    {
      "affiliations": [
        "Department of Orthopedic Surgery, Boston Children's Hospital, Boston, Massachusetts, USA"
      ],
      "name": "Collin May"
    },
    {
      "affiliations": [
        "Department of Biostatistics and Bioinformatics, Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA"
      ],
      "name": "Frank Rockhold"
    },
    {
      "affiliations": [
        "Division of Pediatric Orthopedic Surgery, Montefiore- Einstein, Bronx, New York, USA"
      ],
      "name": "Jacob Schulz"
    },
    {
      "affiliations": [
        "Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Mary Bailey"
    },
    {
      "affiliations": [
        "Duke Clinical Research Institute, Durham, North Carolina, USA"
      ],
      "name": "Karen Chiswell"
    },
    {
      "affiliations": [
        "Duke Clinical Research Institute, Durham, North Carolina, USA"
      ],
      "name": "Jesse DeLaRosa"
    },
    {
      "affiliations": [
        "Department of Orthopaedics, Texas Scottish Rite Hospital for Children, Dallas, Texas, USA"
      ],
      "name": "Jaysson T Brooks"
    },
    {
      "affiliations": [
        "Duke University School of Medicine, Durham, North Carolina, USA"
      ],
      "name": "Anthony A Cantanzano"
    },
    {
      "affiliations": [
        "Orthopaedics, The Hospital for Sick Children, Toronto, Ontario, Canada"
      ],
      "name": "Andrea Chan"
    },
    {
      "affiliations": [
        "Pediatric Orthopaedic Surgery, Rutgers Health, Newark, New Jersey, USA"
      ],
      "name": "Alice Chu"
    },
    {
      "affiliations": [
        "Pediatric Orthopaedics, Hospital for Special Surgery, New York City, New York, USA"
      ],
      "name": "Emily R Dodwell"
    },
    {
      "affiliations": [
        "Dalhousie University, Halifax, Nova Scotia, Canada"
      ],
      "name": "Ron El-Hawary"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery, Texas Scottish Rite Hospital for Children, Dallas, Texas, USA"
      ],
      "name": "Henry Ellis"
    },
    {
      "affiliations": [
        "Children's Orthopedic and Scoliosis, Johns Hopkins All Children's Hospital, Tampa, Florida, USA"
      ],
      "name": "Ryan Fitzgerald"
    },
    {
      "affiliations": [
        "Stanford Medicine Children’s Health 900 Welch Road, Palo Alto, California, USA"
      ],
      "name": "Steven Frick"
    },
    {
      "affiliations": [
        "Division of Orthopaedics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Theodore J Ganley"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Children’s Hospital New Orleans, New Orleans, Louisiana, USA"
      ],
      "name": "Dominic Gargiulo"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, IWK Health Centre, Halifax, Nova Scotia, Canada"
      ],
      "name": "Luke Gauthier"
    },
    {
      "affiliations": [
        "Department of Orthopaedics, Texas Scottish Rite Hospital for Children, Dallas, Texas, USA"
      ],
      "name": "Corey S Gill"
    },
    {
      "affiliations": [
        "Children's Orthopaedic Center, Children's Hospital Los Angeles, Los Angeles, California, USA"
      ],
      "name": "Rachel Goldstein"
    },
    {
      "affiliations": [
        "Department of Orthopaedics and Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"
      ],
      "name": "Matthew F Halsey"
    },
    {
      "affiliations": [
        "Pediatric Orthopaedic Surgery, University Hospitals Rainbow Babies & Children’s Hospital, Cleveland, Ohio, USA"
      ],
      "name": "Christina Hardesty"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Scottish Rite for Children, Dallas, Texas, USA"
      ],
      "name": "Christine Ho"
    },
    {
      "affiliations": [
        "Pediatric Orthopaedic Surgery, Rutgers Health, Newark, New Jersey, USA"
      ],
      "name": "Neil Kaushal"
    },
    {
      "affiliations": [
        "Division of Orthopaedics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"
      ],
      "name": "John Todd Lawrence"
    },
    {
      "affiliations": [
        "Pediatric Orthopaedics, Johns Hopkins Medicine, Baltimore, Maryland, USA"
      ],
      "name": "R Jay Lee"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery and Rehabilitation, The University of Mississippi Medical Center, Jackson, Mississippi, USA"
      ],
      "name": "Khristinn K Leitch"
    },
    {
      "affiliations": [
        "Orthopedic Surgery, New York University School of Medicine, New York City, New York, USA"
      ],
      "name": "Karim Masrouha"
    },
    {
      "affiliations": [
        "Orthopaedics, The University of North Carolina at Chapel Hill Department of Medicine, Chapel Hill, North Carolina, USA"
      ],
      "name": "Stuart Mitchell"
    },
    {
      "affiliations": [
        "Orthopaedics and Physical Performance, Pediatrics, University of Rochester Medical Center, Rochester, New York, USA"
      ],
      "name": "Natasha OMalley"
    },
    {
      "affiliations": [
        "Orthopedic Surgery, Nicklaus Children’s Hospital, Miami, Florida, USA"
      ],
      "name": "Monica Payares- Lizano"
    },
    {
      "affiliations": [
        "University of Liverpool, Liverpool, UK"
      ],
      "name": "Daniel Perry"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Cincinnati Children’s, Cincinnati, Ohio, USA"
      ],
      "name": "Wendy Ramalingam"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Children’s Hospital Colorado, Aurora, Colorado, USA"
      ],
      "name": "Jason Rhodes"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Children’s Hospital Colorado, Aurora, Colorado, USA"
      ],
      "name": "Julia Sanders"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"
      ],
      "name": "Apurva S Shah"
    },
    {
      "affiliations": [
        "Orthopaedic Surgery, Montefiore Health System, Bronx, New York, USA"
      ],
      "name": "Melinda Sharkey"
    },
    {
      "affiliations": [
        "Orthopaedic Institute for Children, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA"
      ],
      "name": "Mauricio Silva"
    },
    {
      "affiliations": [
        "Orthopaedics and Rehabilitation, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA"
      ],
      "name": "Selina Silva"
    },
    {
      "affiliations": [
        "Orthopaedic Institute for Children, University of California Los Angeles David Geffen School of Medicine, Los Angeles, California, USA"
      ],
      "name": "Rachael Thompson"
    },
    {
      "affiliations": [
        "Pediatric Orthopedic Surgery, Stanford Medicine Children’s Health 900 Welch Road, Palo Alto, California, USA"
      ],
      "name": "John Vorhies"
    },
    {
      "affiliations": [
        "Orthopaedics, The Hospital for Sick Children, Toronto, Ontario, Canada"
      ],
      "name": "James Gardner Wright"
    },
    {
      "affiliations": [
        "Division of Orthopaedics & Sports Medicine, Ann and Robert H Lurie Children’s Hospital of Chicago, Chicago, Illinois, USA"
      ],
      "name": "Candace Young"
    },
    {
      "affiliations": [
        "Division of Orthopaedics & Sports Medicine, Ann and Robert H Lurie Children’s Hospital of Chicago, Chicago, Illinois, USA"
      ],
      "name": "Jamie Burgess"
    },
    {
      "affiliations": [],
      "name": "on behalf of IMPACCT Consortium"
    }
  ],
  "title": "Distal Radius Interventions for Fracture Treatment (DRIFT) trial: study protocol for a multicentre randomised clinical trial of completely translated distal radius fractures at paediatric hospitals in North America",
  "uid": "e2f3a6e9-d91c-5e25-bef6-5d3a34a79b2a"
}