Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children

Study Overview
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Brief Summary
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From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3-4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.

Detailed Description
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The clinical trial was approved by the research ethics review committee of the author's hospital and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) [9] diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.

Official Title
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Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial

Conditions
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Upper Limb Fracture

Intervention / Treatment
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* Other: the biobased polyester cast
* Other: the synthetic fiberglass cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital Exclusion Criteria: displaced or unstable fractures indicated for close or open reduction and fixation previous surgeries to the affected upper limb history of any chronic skin pathology (e.g., atopic dermatitis) known allergy to cast materials

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 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
Interventional Model Description: The clinical trial was approved by the research ethics review committee of the author's hospital (Number XXX) and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I9 supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the biobased polyester cast group<br>biobased polyester cast was applied | Other: the biobased polyester cast<br>* long arm casting<br>|
| Active Comparator: the synthetic fiberglass cast group<br>synthetic fiberglass cast was applied | Other: the synthetic fiberglass cast<br>* long arm casting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients with fracture union | clinical outcome | one month after intervention | 
| the number of complications | clinical outcome | one month after intervention | 
| patient satisfaction questionnaire |  | one month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric upper limb fracture, casting, Bioabased polyester, Synthetic cast