Distal Radius Interventions for Fracture Treatment
DRIFT
Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)
2 other identifiers
interventional
334
2 countries
26
Brief Summary
This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Start
First participant enrolled
April 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
June 29, 2025
August 1, 2024
4.6 years
October 4, 2021
June 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
functional and patient reported outcomes
pediatric upper extremity function PROMIS computer adaptive test (PROMIS UE CAT)
1 year follow-up
Secondary Outcomes (11)
PROMIS UE Computerized Adaptive Test (CAT)
6 weeks and 3, and 6 months
Disabilities of the Arm, Shoulder and Hand (DASH) S/PA
6 weeks and 3, and 6 months
PROMIS Pain interference
6 weeks, 3, 6, and 12 months
Wong-Baker Faces Pain scores
6 weeks, 3, 6, and 12 months
Radiographic alignment of bone
6 weeks and 3 months
- +6 more secondary outcomes
Study Arms (2)
Non-sedated Immobilization
EXPERIMENTALImmobilization in a cast without reduction
Formal Reduction
ACTIVE COMPARATORclosed reduction under conscious sedation followed by casting
Interventions
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form by parent or legal guardian
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 4-10 years
- Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement
- Fracture is less than 5cm from the distal radial growth plate
- Willing to adhere to the immobilization regimen
- Fracture is acute (occurred less than 10 days prior to consent and assignment of treatment arm AND with ability to be taken to operating room (OR) or reduced in the emergency department (ED)
You may not qualify if:
- Physeal involvement of fracture
- Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
- Fracture cannot be treated with acute reduction due to being older than 10 days
- Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California- Los Angeles Medical Center
Los Angeles, California, 90095, United States
Nemours Children's Hospital
Wilmington, Delaware, 19803, United States
Niklaus Children's Hospital
Miami, Florida, 33155, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
Riley Children's
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
TRIA Health Partners
Minneapolis, Minnesota, 55102, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University Hospital- Rutgers
New Brunswick, New Jersey, 07103, United States
University of New Mexico - Carrie Tingley
Albuquerque, New Mexico, 87106, United States
New York University-Langone Health
New York, New York, 10016, United States
Hospital of Special Surgery
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati's Children's Hospital
Cincinnati, Ohio, 452229, United States
University Hospitals Rainbow Babies & Children
Cleveland, Ohio, 44106, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Scottish Rite Hospital for Children
Dallas, Texas, 75219, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
The Hospital for Sick Children
Toronto, Canada, Canada
Related Publications (1)
Balmert Bonner L, Janicki J, Georgiadis A, Truong W, Harris Beauvais D, Belthur M, Daley EL, Franzone J, Howard A, May C, Rockhold F, Schulz J, Bailey M, Chiswell K, DeLaRosa J, Brooks JT, Cantanzano AA, Chan A, Chu A, Dodwell ER, El-Hawary R, Ellis H, Fitzgerald R, Frick S, Ganley TJ, Gargiulo D, Gauthier L, Gill CS, Goldstein R, Halsey MF, Hardesty C, Ho C, Kaushal N, Lawrence JT, Lee RJ, Leitch KK, Masrouha K, Mitchell S, OMalley N, Payares-Lizano M, Perry D, Ramalingam W, Rhodes J, Sanders J, Shah AS, Sharkey M, Silva M, Silva S, Thompson R, Vorhies J, Wright JG, Young C, Burgess J; IMPACCT Consortium. 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. BMJ Open. 2025 Oct 29;15(10):e088273. doi: 10.1136/bmjopen-2024-088273.
PMID: 41161832DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jospeh Janicki, MD
Ann and Robert H. Lurie Children's Hospital of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Surgeon
Study Record Dates
First Submitted
October 4, 2021
First Posted
November 23, 2021
Study Start
April 9, 2023
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
June 29, 2025
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share