HM vs Fibreglass Cast Immbolization for Supracondylar Fractures

Not Applicable

Completed

• Conditions: Pediatric Supracondylar Humeral Fracture
• Interventions: Device: HM Cast; Device: Fibreglass Cast

• Registration Number: NCT05430074
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-24
• Study Start: 2022-08-16
• Primary Completion: 2022-11-28
• Study Completion: 2022-11-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HM Cast	HM Cast	-
Fibreglass Cast	Fibreglass Cast	-

Primary Outcome Measures

Name	Time	Method
Presence of Skin Rash	4 weeks post-casting	The presence of skin rash will be assessed by the study team member upon cast removal.
Clinical Outcome - Loss of Reduction	4 weeks post-casting	Based on the radiographs taken 4 weeks after casting, the Baumann's angle will used to assess for any loss of reduction.
Comfort and Overall Satisfaction	4 weeks post-casting	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Cast Application	During Procedure (Cast Application - First Visit)	The duration of each cast application with the respective cast materials will be recorded and analysed.

Trial Locations

Locations (1)

KK Women's and Children Hospital; 🇸🇬 Singapore, Singapore