Splinting Versus Casting for Type I Supracondylar Fractures

January 8, 2018 updated by: Kishore Mulpuri, University of British Columbia

Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial

Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital

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.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible participants will be recruited from the Emergency Department at BC Children's Hospital

Description

Inclusion Criteria:

  • Ages 3-12
  • Type 1 supracondylar fracture

Exclusion Criteria:

  • A type 2 or 3 supracondylar fracture
  • Neurovascular compromise associated with the fracture
  • Previous diagnosis with a metabolic or structural bone disease
  • Other fractures to ipsilateral upper extremity
  • History of injury to affected elbow

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Above Elbow Cast + Collar/cuff
Participants randomized to this group will be treated with an Above Elbow Cast & collar/cuff for 3 weeks
Procedure: Above Elbow Cast
Long Arms Splint + Collar/Cuff
Participants randomized to this group will be treated with a long arm splint & collar/cuff for 3 weeks
Procedure: Long Arm Splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baumann's Angle
Time Frame: 6 Months
Baumann's angle of the injured elbow will be measured 6 months following the injury
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humero-Capitellar Angle
Time Frame: 6 Months
Humero-Capitellar Angle will be measured 6 Months following the injury
6 Months
Functional Outcome Questionnaire
Time Frame: 6 Months
All participants will complete the Activity Scale for Kids-P 6 months following the injury
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Kishore Mulpuri, MBBS, MS, MHSc, University of British Columbia

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 Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-01520

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Fractures

Clinical Trials on Above Elbow Cast

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe