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

Study Overview
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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

Official Title
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Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter

Conditions
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Fracture Forearm

Intervention / Treatment
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* Device: short-arm fiberglass cast
* Device: long-arm fiberglass cast


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: short-arm fiberglass cast<br>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. | Device: short-arm fiberglass cast<br>* fracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast<br>|
| Active Comparator: long-arm fiberglass cast<br>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. | Device: long-arm fiberglass cast<br>* fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | in the first four weeks after trauma |