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

Not Applicable

Completed

• Conditions: Salter-Harris Type I; Forearm Fracture; Salter-Harris Type 2; Radius Fractures
• Interventions: Device: combi cast

• Registration Number: NCT03297047
• Lead Sponsor: University Children's Hospital, Zurich

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.

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-29
• Study Start: 2017-10-02
• Primary Completion: 2019-08-29
• Study Completion: 2019-08-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
forearm combi cast	combi cast	Treatment with a forearm combi cast should be a sufficient immobilization
upper arm combi cast	combi cast	standardized treatment

Primary Outcome Measures

Name	Time	Method
secondary displacement of the fracture	Significant difference of secondary displaced fractures 28 days after closed reduction of fracture	radiological evaluation

Secondary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Children's Hospital; 🇨🇭 Zurich, Switzerland