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Clinical Trials/NCT03297047
NCT03297047
Completed
Not Applicable

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

University Children's Hospital, Zurich1 site in 1 country120 target enrollmentOctober 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Salter-Harris Type I
Sponsor
University Children's Hospital, Zurich
Enrollment
120
Locations
1
Primary Endpoint
secondary displacement of the fracture
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2017
End Date
August 29, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Children's Hospital, Zurich
Responsible Party
Principal Investigator
Principal Investigator

Georg Staubli

Dr. med.

University Children's Hospital, Zurich

Eligibility Criteria

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

Outcomes

Primary Outcomes

secondary displacement of the fracture

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

radiological evaluation

Secondary Outcomes

  • Mobilisation of elbow joint after cast removal(4 weeks and 7 weeks after closed reduction of fracture)
  • Wearing comfort of the two different casts(5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture)

Study Sites (1)

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