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Completed

NCT Number: NCT05430074

HM vs Fibreglass Cast Immbolization for Supracondylar Fractures

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.

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Key information

Age range

0 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children Hospital

Singapore, 229899

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM Cast

Device

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

Fibreglass Cast

Device

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

Primary outcomes

  1. Clinical Outcome - Loss of Reduction

    Time frame: 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.

  2. Comfort and Overall Satisfaction

    Time frame: 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.

  3. Presence of Skin Rash

    Time frame: 4 weeks post-casting

    The presence of skin rash will be assessed by the study team member upon cast removal.

Secondary outcomes

  1. Duration of Cast Application

    Time frame: During Procedure (Cast Application - First Visit)

    The duration of each cast application with the respective cast materials will be recorded and analysed.

Other outcomes

  1. Water Contact (For HM casts only)

    Time frame: 4 weeks post-casting

    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).

  2. Duration and Intensity of Pain

    Time frame: 4 weeks post-casting

    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".

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.