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

Primary Purpose

Fracture Forearm

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
short-arm fiberglass cast
long-arm fiberglass cast
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Forearm

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University Children's Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

short-arm fiberglass cast

long-arm fiberglass cast

Arm 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.

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.

Outcomes

Primary Outcome Measures

Rate of fracture displacement
difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)

Secondary Outcome Measures

Full Information

First Posted
November 29, 2021
Last Updated
May 17, 2022
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05156749
Brief Title
Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in Children
Official Title
Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Forearm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
short-arm fiberglass cast
Arm Type
Experimental
Arm 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.
Arm Title
long-arm fiberglass cast
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
short-arm fiberglass cast
Intervention Description
fracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast
Intervention Type
Device
Intervention Name(s)
long-arm fiberglass cast
Intervention Description
fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast
Primary Outcome Measure Information:
Title
Rate of fracture displacement
Description
difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)
Time Frame
in the first four weeks after trauma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Seiler, PD
Phone
+41 44 266 43 10
Email
michelle.seiler@kispi.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Seiler, PD
Organizational Affiliation
University Children's Hospital, Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University Children's Hospital Zurich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Seiler, MD
Phone
+41 44 266 32 10
Email
michelle.seiler@kispi.uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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