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Fracture reduction with ultrasound for Ultrasound

N/A
Waitlist Available
Led By Joni Rabiner, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who present to the Pediatric Emergency Department (PED) with a confirmed displaced forearm fracture that will require reduction by orthopedic surgery in the PED will be eligible for inclusion in this study.
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of bone setting procedure, an average of 10-20 minutes
Awards & highlights

Study 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.

Eligible Conditions
  • Broken Arm
  • Ultrasound

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of bone setting procedure, an average of 10-20 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of bone setting procedure, an average of 10-20 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparing Rate of Reduction Between the Experimental and Control Arm/Group
Secondary outcome measures
Adequacy of Reduction Based on a Composite Assessment of Degree of Angulation and Displacement
Compare Provider Satisfaction With the Reduction Procedure Between the Experimental and Control Arm/Group
Duration of Reduction
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fracture reduction with ultrasoundExperimental Treatment2 Interventions
Ultrasound guided Fracture reduction involves closed fracture reduction with the use of real-time ultrasound imaging, prior to, during and after the reduction procedure. C-arm or portable x-ray may also be used as an adjunct.
Group II: Fracture reduction without ultrasoundActive Control1 Intervention
Fracture reduction as per standard of care involves closed fracture reduction without real-time imaging, or with c-arm or portable x-ray. Closed reduction of a fractured bone. Closed reduction is a procedure to set (reduce) a broken bone without surgery. This allows the bone to grow back together. It works best when it is done as soon as possible after the bone breaks.

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,192 Total Patients Enrolled
Joni Rabiner, MDPrincipal Investigator - Columbia University
Montefiore Medical Center

Frequently Asked Questions

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~0 spots leftby Apr 2025