RECRUITING

Distal Radius Interventions for Fracture Treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Reduction and Nonreduction Treatment of Displaced Pediatric Distal Radius Fractures (Peds-DRIFT Trial - Distal Radius Interventions for Fracture Treatment)

Quick Facts

Study Start:2023-04-09

Study Completion:2028-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05131685

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 10 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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)	1. Physeal involvement of fracture 2. Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease 3. Fracture cannot be treated with acute reduction due to being older than 10 days 4. 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.

Inclusion Criteria

Exclusion 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)

1. Physeal involvement of fracture
2. Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease
3. Fracture cannot be treated with acute reduction due to being older than 10 days
4. 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.

Contacts and Locations

Study Contact

Jamie Burgess, PhD

CONTACT

312-227-6531

jburgess@luriechildrens.org

Candace Young, BS

CONTACT

(312) 227-6427

cayoung@luriechildrens.org

Principal Investigator

Jospeh Janicki, MD

PRINCIPAL_INVESTIGATOR

Ann and Robert H. Lurie Children's Hospital of Chicago

Study Locations (Sites)

Phoenix Children's Hospital

Phoenix, Arizona, 85016

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

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

University Hospitals Rainbow Babies & Children

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Jospeh Janicki, MD, PRINCIPAL_INVESTIGATOR, Ann and Robert H. Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-09

Study Completion Date2028-08-31

Study Record Updates

Study Start Date2023-04-09

Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

Fracture Distal Radius