HM vs Fibreglass Casts in Treating Pediatric Supracondylar Humeral Fractures
Primary Purpose
Pediatric Supracondylar Humeral Fracture
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
HM Cast
Fibreglass Cast
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Supracondylar Humeral Fracture focused on measuring Supracondylar humeral fracture, Pediatric fracture, Hybrid mesh cast, Fibreglass cast
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
Sites / Locations
- KK Women's and Children Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
HM Cast
Fibreglass Cast
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Presence of Skin Rash
The presence of skin rash will be assessed by the study team member upon cast removal.
Secondary Outcome Measures
Duration of Cast Application
The duration of each cast application with the respective cast materials will be recorded and analysed.
Full Information
NCT ID
NCT05430074
First Posted
June 16, 2022
Last Updated
March 15, 2023
Sponsor
KK Women's and Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05430074
Brief Title
HM vs Fibreglass Casts in Treating Pediatric Supracondylar Humeral Fractures
Official Title
Treatment of Paediatric Supracondylar Humeral Fracture With Cast Immobilization: A Randomized Controlled Trial - Hybrid Mesh Versus Fibreglass
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
November 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Supracondylar Humeral Fracture
Keywords
Supracondylar humeral fracture, Pediatric fracture, Hybrid mesh cast, Fibreglass cast
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HM Cast
Arm Type
Other
Arm Title
Fibreglass Cast
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
HM Cast
Intervention Description
Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts.
Intervention Type
Device
Intervention Name(s)
Fibreglass Cast
Intervention Description
Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts.
Primary Outcome Measure Information:
Title
Clinical Outcome - Loss of Reduction
Description
Based on the radiographs taken 4 weeks after casting, the Baumann's angle will used to assess for any loss of reduction.
Time Frame
4 weeks post-casting
Title
Comfort and Overall Satisfaction
Description
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.
Time Frame
4 weeks post-casting
Title
Presence of Skin Rash
Description
The presence of skin rash will be assessed by the study team member upon cast removal.
Time Frame
4 weeks post-casting
Secondary Outcome Measure Information:
Title
Duration of Cast Application
Description
The duration of each cast application with the respective cast materials will be recorded and analysed.
Time Frame
During Procedure (Cast Application - First Visit)
Other Pre-specified Outcome Measures:
Title
Water Contact (For HM casts only)
Description
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).
Time Frame
4 weeks post-casting
Title
Duration and Intensity of Pain
Description
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".
Time Frame
4 weeks post-casting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
KK Women's and Children Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HM vs Fibreglass Casts in Treating Pediatric Supracondylar Humeral Fractures
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