NCT05430074

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 0 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Supracondylar Humeral Fracture

Interventions

Type	Name	Description
DEVICE	HM Cast	Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.
DEVICE	Fibreglass Cast	Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.

Timeline

• Start date: 2022-08-16
• Primary completion: 2022-11-28
• Completion: 2022-11-28
• First posted: 2022-06-24
• Last updated: 2024-10-17

Locations

1 site across 1 country: Singapore