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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05430074
Enrollment
79
Registered
2022-06-24
Start date
2022-08-16
Completion date
2022-11-28
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Supracondylar Humeral Fracture

Keywords

Supracondylar humeral fracture, Pediatric fracture, Hybrid mesh cast, Fibreglass cast

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.

Interventions

DEVICEHM Cast

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

DEVICEFibreglass Cast

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

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Outcome - Loss of Reduction4 weeks post-castingBased on the radiographs taken 4 weeks after casting, the Baumann's angle will used to assess for any loss of reduction.
Comfort and Overall Satisfaction4 weeks post-castingThrough 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.
Presence of Skin Rash4 weeks post-castingThe presence of skin rash will be assessed by the study team member upon cast removal.

Secondary

MeasureTime frameDescription
Duration of Cast ApplicationDuring Procedure (Cast Application - First Visit)The duration of each cast application with the respective cast materials will be recorded and analysed.

Other

MeasureTime frameDescription
Water Contact (For HM casts only)4 weeks post-castingThrough 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).
Duration and Intensity of Pain4 weeks post-castingPatients 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.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026