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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM Cast | Other |
| |
| Fibreglass Cast | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM Cast | Device | Subjects assigned to this arm will be treated via cast immobilisation with the use of HM casts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks post-casting |
| 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. | 4 weeks post-casting |
| Presence of Skin Rash | The presence of skin rash will be assessed by the study team member upon cast removal. | 4 weeks post-casting |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Cast Application | The duration of each cast application with the respective cast materials will be recorded and analysed. | During Procedure (Cast Application - First Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Water Contact (For HM casts only) | 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). | 4 weeks post-casting |
| Duration and Intensity of Pain |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children Hospital | Singapore | 229899 | Singapore |
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| ID | Term |
|---|---|
| D002370 | Casts, Surgical |
| ID | Term |
|---|---|
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
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| Fibreglass Cast | Device | Subjects assigned to this arm will be treated via cast immobilisation with the use of Fibreglass casts. |
|
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". |
| 4 weeks post-casting |
| D004864 |
| Equipment and Supplies |
| D053831 | Surgical Fixation Devices |