Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children

September 16, 2019 updated by: Georg Staubli, University Children's Hospital, Zurich

Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children

The standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children with distal radial or forearm fractures needing closed reduction are eligible for this study. By drawing lots either an immobilization with an upper arm or forearm combicast will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be performed to check the rate of displacement, consolidation time, wearing comfort and movement of the elbow joint after taking off the cast.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

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

  • Switzerland
      • Zurich, Switzerland, 8032
        • 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

4 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • open growth Zone
  • displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction
  • written informed consent

Exclusion Criteria:

  • intraarticular fractures
  • open fractures
  • unstable fractures

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: upper arm combi cast
standardized treatment
Device: combi cast
upper arm or forearm combi cast
EXPERIMENTAL: forearm combi cast
Treatment with a forearm combi cast should be a sufficient immobilization
Device: combi cast
upper arm or forearm combi cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondary displacement of the fracture
Time Frame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
radiological evaluation
Significant difference of secondary displaced fractures 28 days after closed reduction of fracture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wearing comfort of the two different casts
Time Frame: 5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
help in daily life in hours
5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
Mobilisation of elbow joint after cast removal
Time Frame: 4 weeks and 7 weeks after closed reduction of fracture
Mobility of the elbow joint in degrees (flection and extension measurement)
4 weeks and 7 weeks after closed reduction of fracture

Collaborators and Investigators

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

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Georg Staubli, Dr. med, Emergency department, University Children's Hospital Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

October 2, 2017

Primary Completion (ACTUAL)

August 29, 2019

Study Completion (ACTUAL)

August 29, 2019

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (ACTUAL)

September 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Forearm combi cast 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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