HM vs Fibreglass Cast Immbolization for Supracondylar Fractures

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Supracondylar Humeral Fracture
• Intervention / Treatment: Device: HM Cast; Device: Fibreglass Cast

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HM Cast	Device: HM Cast; Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.
Other: Fibreglass Cast	Device: Fibreglass Cast; Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Water Contact (For HM casts only)	Through a questionnaire, patients with HM casts will be asked if they had wetted their casts during showers/baths and if they had participated in any water activities (such as swimming or visits to the waterparks).	4 weeks post-casting
Duration and Intensity of Pain	Patients will be assessed based on the duration and intensity of pain, and the duration of painkillers used. The intensity of the pain will be assessed via the Faces Pain Scale - Revised, which is a validated self-reporting measure for children to score their pain on rating from 0 to 10, with 0 being "No pain" and 10 being "Very much pain".	4 weeks post-casting

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): November 28, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Supracondylar humeral fracture; Pediatric fracture; Hybrid mesh cast; Fibreglass cast
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: CIRB Ref: 2022/2409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No