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

Not Applicable

Recruiting

• Conditions: Fracture Forearm
• Interventions: Device: short-arm fiberglass cast; Device: long-arm fiberglass cast

• Registration Number: NCT05156749
• Lead Sponsor: University Children's Hospital, Zurich

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2021-11-29
• Study Start: 2021-12-07
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short-arm fiberglass cast	short-arm fiberglass cast	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.
long-arm fiberglass cast	long-arm fiberglass cast	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.

Primary Outcome Measures

Name	Time	Method
Rate of fracture displacement	in the first four weeks after trauma	difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)

Trial Locations

Locations (1)

University Children's Hospital Zurich; 🇨🇭 Zürich, Switzerland