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Completed

NCT Number: NCT03297047

Comparing Forearm and Upper Arm Combi Cast for 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.

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Key information

Conditions

Salter-Harris Type I Arm Injuries Forearm Fracture Forearm Injuries Fractures, Bone Radius Fractures Salter-Harris Type 2 Wounds and Injuries

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital

Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combi cast

Device

upper arm or forearm combi cast

Primary outcomes

  1. secondary displacement of the fracture

    Time frame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture

    radiological evaluation

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2017
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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