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Distal Radius Interventions for Fracture Treatment

NCT05131685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2025-06-29

No results posted yet for this study

Summary

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

Conditions

  • Fracture Distal Radius

Interventions

PROCEDURE

Reduction

closed reduction under conscious sedation followed by casting

PROCEDURE

Immobilization

immobilization in cast without reduction

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-09
Primary Completion
2027-10-31
Completion
2028-08-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131685 on ClinicalTrials.gov