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临床试验/NCT05430074
NCT05430074已完成不适用

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

KK Women's and Children's Hospital2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2022年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
79
试验地点
2
主要终点
Presence of Skin Rash

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • First Presentation of Supracondylar humeral fracture (Type I and IIa modified Gartland's classification)

排除标准

  • Prior treatment of supracondylar humeral fracture
  • Previous elbow injuries
  • Open fractures
  • Polytrauma
  • Neurovascular injuries

结局指标

主要结局

Presence of Skin Rash

时间窗: 4 weeks post-casting

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

Clinical Outcome - Loss of Reduction

时间窗: 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.

Comfort and Overall Satisfaction

时间窗: 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.

次要结局

  • Duration of Cast Application(During Procedure (Cast Application - First Visit))

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kenneth Wong Pak Leung

Consultant

KK Women's and Children's Hospital

研究点 (2)

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