HM vs Fibreglass Casts in Treating Pediatric Supracondylar Humeral Fractures

Study Overview
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Brief Summary
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Supracondylar humeral fractures are the most common elbow fractures in children and cast immobilization continues to remain as the recommended treatment for modified Gartland's classification Type I and Type IIa injuries. Apart from plaster of Paris and fibreglass casts, the use of waterproof, tubular hybrid mesh (HM) casts have been gaining traction for cast immobilization. Although the use of HM cast has been reported to have similar clinical outcomes and overall patient satisfaction scores to the fibreglass cast, the results of the recent studies are only limited and generalizable only to paediatric distal radius fractures. As the application method of HM and fibreglass casts are fundamentally different, it has not been reported if the difference in application duration between the cast materials is significant and its potential implications in outpatient clinic operation. Hence, through a randomized controlled trial, this study primarily aims to investigate if the clinical outcomes, patient satisfaction and duration of cast application with the HM casts would be comparable with fibreglass casts in children with supracondylar humeral fractures. Through this study, the investigators hope to evaluate the advantages and disadvantages of the respective casting material which may better aid physicians in deciding a more appropriate cast material for treating paediatric supracondylar humeral fractures with cast immobilization and the implications of casting duration on clinic operations.

Official Title
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Treatment of Paediatric Supracondylar Humeral Fracture With Cast Immobilization: A Randomized Controlled Trial - Hybrid Mesh Versus Fibreglass

Conditions
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Pediatric Supracondylar Humeral Fracture

Intervention / Treatment
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* Device: HM Cast
* Device: Fibreglass Cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First Presentation of Supracondylar humeral fracture (Type I and IIa modified Gartland's classification) Exclusion Criteria: Prior treatment of supracondylar humeral fracture Previous elbow injuries Open fractures Polytrauma Neurovascular injuries

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 10 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 |
| --- | --- |
| Other: HM Cast<br> | Device: HM Cast<br>* Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.<br>|
| Other: Fibreglass Cast<br> | Device: Fibreglass Cast<br>* Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome - Loss of Reduction | Based on the radiographs taken 4 weeks after casting, the Baumann's angle will used to assess for any loss of reduction. | 4 weeks post-casting | 
| Comfort and Overall Satisfaction | Through a questionnaire, the patients and their parents will be asked to rate the patients' experience on adaptability, weight of the cast, itch, heat, sweatiness, smell, comfort and overall satisfaction. For each question, on the scales of 1 to 5, the rating of 1 would designate as the least desirable option and the rating of 5 being the most desirable option. | 4 weeks post-casting | 
| Presence of Skin Rash | The presence of skin rash will be assessed by the study team member upon cast removal. | 4 weeks post-casting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Cast Application | The duration of each cast application with the respective cast materials will be recorded and analysed. | During Procedure (Cast Application - First Visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supracondylar humeral fracture, Pediatric fracture, Hybrid mesh cast, Fibreglass cast