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

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

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

Treatments

Device: combi cast

Study type

Interventional

Funder types

Other

Identifiers

NCT03297047
Forearm combi cast 2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

upper arm combi cast
Active Comparator group
Description:
standardized treatment
Treatment:
Device: combi cast
forearm combi cast
Experimental group
Description:
Treatment with a forearm combi cast should be a sufficient immobilization
Treatment:
Device: combi cast

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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