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Trial of Ultrasound Guidance for Reduction of Pediatric Forearm Fractures

NCT03097757 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-01-09

Study results available
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Summary

The primary objective of this study is to assess the utility of ultrasound guidance in the closed reduction of pediatric forearm fractures in the pediatric emergency department. The investigators will compare post-reduction radiologic outcomes between the experimental group (ultrasound guided closed forearm fracture reduction) and control group (standard of care blinded closed forearm fracture reduction) to determine if there is a difference in the number of adequate reductions between groups.

Secondary objectives include comparing provider satisfaction with the reduction procedure, number of patients requiring repeat reductions, time for reduction, number of patients requiring operative repair after reduction, with the reduction procedure and comparison between post-reduction ultrasound and x-ray interpretation.

Conditions

  • Forearm Fracture
  • Ultrasound

Interventions

RADIATION

Ultrasound - guided fracture reduction

Ultrasound will be used as a real-time imaging modality to guide forearm fracture reduction.

PROCEDURE

Standard of care fracture reduction

Closed reduction of a fractured bone.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Joni Rabiner, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2017-07-31
Completion
2017-07-31
FDA Device
Yes

Countries

  • United States

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 NCT03097757 on ClinicalTrials.gov