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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03297047

Enrollment

120

Registered

2017-09-29

Start date

2017-10-02

Completion date

2019-08-29

Last updated

2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Forearm Fracture, Radius Fractures, Salter-Harris Type 2, Salter-Harris Type I

Keywords

cast, fracture, immobilization, displacement, child

Brief summary

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.

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.

Interventions

DEVICEcombi cast

upper arm or forearm combi cast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

one Group with upper arm cast one Group with forearm cast

Eligibility

Sex/Gender

ALL

Age

4 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026