HM vs Fibreglass Cast Immbolization for Supracondylar Fractures

NCT ID: NCT05430074

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-16
• Study Completion Date: 2022-11-28

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.

Conditions

Pediatric Supracondylar Humeral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HM Cast

Group Type: OTHER

HM Cast

Intervention Type: DEVICE

Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.

Fibreglass Cast

Group Type: OTHER

Fibreglass Cast

Intervention Type: DEVICE

Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.

Interventions

HM Cast

Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.

Intervention Type: DEVICE

Fibreglass Cast

Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kenneth Wong Pak Leung

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

KK Women's and Children Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

CIRB Ref: 2022/2409

Identifier Type: -

Identifier Source: org_study_id