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

NCT ID: NCT05156749

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2025-12-31

Brief Summary

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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

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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

Conditions

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Fracture Forearm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

short-arm fiberglass cast

Intervention Type DEVICE

fracture stabilization of salter harris I/II fractures with a fiberglass short-arm 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.

Group Type ACTIVE_COMPARATOR

long-arm fiberglass cast

Intervention Type DEVICE

fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast

Interventions

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short-arm fiberglass cast

fracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast

Intervention Type DEVICE

long-arm fiberglass cast

fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Seiler, PD

Role: STUDY_CHAIR

University Children's Hospital, Zurich

Locations

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University Children's Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Michelle Seiler, PD

Role: CONTACT

Phone: +41 44 266 43 10

Email: [email protected]

Facility Contacts

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Michelle Seiler, MD

Role: primary

Other Identifiers

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UChildrenZurich_salter harris

Identifier Type: -

Identifier Source: org_study_id