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Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in Children

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Enrolling

Conditions

Fracture Forearm

Treatments

Device: long-arm fiberglass cast
Device: short-arm fiberglass cast

Study type

Interventional

Funder types

Other

Identifiers

NCT05156749
UChildrenZurich_salter harris

Details and patient eligibility

About

The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.

Full description

The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions

Enrollment

120 estimated patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Salter Harris I or II fracture of the distal radius or a forearm fracture
  • informed consent

Exclusion criteria

  • open/instable/intraarticular fracture
  • age <4 years or > 16years
  • no informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

short-arm fiberglass cast
Experimental group
Description:
salter harris fractures of the distal radius/forearm in children are usually treated with fiberglass long-arm casts. The investigators were able to demonstrate that in distal metaphyseal forearm fracture, treatment with a short-arm cast is not inferior to a long-arm cast. Patients are going to receive a short-arm cast for fracture treatment.
Treatment:
Device: short-arm fiberglass cast
long-arm fiberglass cast
Active Comparator group
Description:
salter harris fractures of the distal radius/forearm in children are usually treated with a fiberglass long-arm cast. Patients are going to receive a long-arm cast for fracture treatment.
Treatment:
Device: long-arm fiberglass cast

Trial contacts and locations

1

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Central trial contact

Michelle Seiler, PD

Data sourced from clinicaltrials.gov

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