Clinical trial NCT05430074: HM vs Fibreglass Cast Immbolization for Supracondylar Fractures
Official title: Treatment of Paediatric Supracondylar Humeral Fracture With Cast Immobilization: A Randomized Controlled Trial - Hybrid Mesh Versus Fibreglass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Supracondylar Humeral Fracture
Keywords: Supracondylar humeral fracture
Pediatric fracture
Hybrid mesh cast
Fibreglass cast
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-24
Enrollment: 79
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical Outcome - Loss of Reduction
timeFrame: 4 weeks post-casting
measure: Comfort and Overall Satisfaction
timeFrame: 4 weeks post-casting
measure: Presence of Skin Rash
timeFrame: 4 weeks post-casting
Secondary outcomes:
measure: Duration of Cast Application
timeFrame: During Procedure (Cast Application - First Visit)
Other outcomes:
measure: Water Contact (For HM casts only)
timeFrame: 4 weeks post-casting
measure: Duration and Intensity of Pain
timeFrame: 4 weeks post-casting
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children Hospital
Study officials:
References: