Recruiting

Sedated ReductionDistal Radius Interventions for Fracture Treatment

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT05131685

Conditions

Fracture Distal Radius

Eligibility Criteria

Sex: All

Age: 4 - 10

Healthy Volunteers: Not accepted

Interventions

Reduction

Immobilization

Study Details

Brief summary:

This protocol describes a multicenter, prospective randomized superiority trial with a patient preference cohort comparing functional outcomes between children treated with sedated reduction versus no formal reduction.

Conditions

Fracture Distal Radius

Study ID

NCT05131685

Start date

Apr 9, 2023

Status verified date

Jun, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 4 - 10

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form by parent or legal guardian
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 4-10 years
4. Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement
5. Fracture is less than 5cm from the distal radial growth plate
6. Willing to adhere to the immobilization regimen
7. 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)

Exclusion Criteria:

1. Physeal involvement of fracture
2. Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
3. Fractures other than the ulna near the same level in the ipsilateral arm
4. Fracture cannot be treated with acute reduction due to being older than 10 days
5. 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

Study Design

Enrollment

334 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Non-sedated Immobilization

Immobilization in a cast without reduction

active comparator: Formal Reduction

closed reduction under conscious sedation followed by casting

Interventions

Reduction

closed reduction under conscious sedation followed by casting

Immobilization

immobilization in cast without reduction

Primary outcome measure

PROMIS Pediatric CAT V2.0 - Physical Function- Upper Extremity [ Time Frame: 1 year follow-up ]

Central Contacts and Locations

Central contacts

Jamie Burgess, PhD

312-227-6531 jburgess@luriechildrens.org

Michelle Adzido, MA

312-227-2492 madzido@luriechildrens.org

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Kajol Majhail

(602) 933- 2712 Kmajhail@phoenixchildrens.com

Principal Investigator:

Mohan Belthur, MD

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Sam Wimmer

swimmer@chla.usc.edu

Principal Investigator:

Rachel Goldstein, MD

University of California- Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Johnathan You

johnathanyou@mednet.ucla.edu

Principal Investigator:

Maurcio Silva, MD

Nemours Children's Hospital

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Susan Dubowy, PA-C

susan.dubowy@nemours.org

Principal Investigator:

Jeanne Franzone, MD

Niklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Stephanie Uriguen

stephanie.uriguen@nicklaushealth.org

Principal Investigator:

Monica Payares, MD

Riley Children's Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Molly Moore

momfreed@iupui.edu

Principal Investigator:

Erika Daley, MD

Riley Children's

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Molly Moore

momfreed@iupui.edu

Principal Investigator:

Erika Daley, MD

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Gabrielle Reichard

greicha1@jhmi.edu

Principal Investigator:

R. Jay Lee, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Maya Fajardo

maya.fajardo@childrens.harvard.edu

Principal Investigator:

Collin May, MD

TRIA Health Partners

Recruiting

Minneapolis, Minnesota, United States, 55102

Contacts

Mairead Vanni

mairead.vanni@tria.com

Principal Investigator:

Deb Bohn, MD

Gillette Children's Specialty Healthcare

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Jamie Price

(651) 325-2315 jamienprice@gillettechildrens.com

Principal Investigator:

Walter Truong, MD

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Sandra Powe

spowe@umc.edu

Principal Investigator:

Kellie Leitch, MD

University Hospital- Rutgers

Recruiting

New Brunswick, New Jersey, United States, 07103

Contacts

Charlene Wetterstrand

charlene.wetterstrand@rutgers.edu

Principal Investigator:

Neil Kaushal, MD

University of New Mexico - Carrie Tingley

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Leorrie Watson

leatencio@salud.unm.edu

Principal Investigator:

Selina Silva, MD

Hospital of Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Pari Palandjian

palandjianp@HSS.EDU

Principal Investigator:

Emily Dodwell, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Ashley Owens

ashley_owens@urmc.rochester.edu

Principal Investigator:

Natasha O'Malley, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Leila Alvandi

lalvandi@montefiore.org

Principal Investigator:

Jacob Schulz, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Malvika Choudhari

(919) 966-9718 malvika_choudhari@med.unc.edu

Principal Investigator:

Stuart Leighton Mitchell, MD

Cincinnati's Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 452229

Principal Investigator:

Wendy Ramalingam, MD

University Hospitals Rainbow Babies & Children

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Christina Hardesty

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Zewdi Cass

cassz@ohsu.edu

Principal Investigator:

Matthew Halsey, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Divya Talwar

talward@chop.edu

Principal Investigator:

Ted Ganley, MD

Texas Scottish Rite Hospital for Children

Recruiting

Dallas, Texas, United States, 75219

Contacts

Chinelo Onubogu

chinelo.onubogu@tsrh.org

Principal Investigator:

Corey Gill, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Justine Kasay

jxkasay@texaschildrens.org

Principal Investigator:

Dorothy Harris-Beauvais, MD

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2026-07-01.