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临床试验/NCT07350525
NCT07350525已完成不适用

CASTomize 4D Printed Cast Versus Fibreglass Casts for Distal Radius Fractures

Tan Tock Seng Hospital0 个研究点目标入组 25 人开始时间: 2024年1月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25

研究概览

简要总结

This study is a randomised control trial comparing Castomize 4D printed cast versus conventional fibreglass casts in isolated conservatively treated distal radius fractures. The primary outcome measure is fracture reduction. Secondary outcome measures include patient reported outcome measures such as the Adult Rated Cast Evaluation Questionnaire (ARCEQ), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, cost-effectiveness and adverse events occurrence. In total, 30 patients will be included and followed for 6 months.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Age ≥ 21 years
  • Distal radius fracture for conservative treatment within 3 weeks of initial injury

排除标准

  • Concomitant injuries to the ipsilateral extremity, interfering with the treatment of the DRF (Example: concomitant elbow fracture that requires further immobilisation with a above elbow cast)
  • Inability to complete study forms due to any cognitive, mental issues.
  • Pregnant women

研究者

发起方
Tan Tock Seng Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

YAM GUI JIE MICHAEL

Dr

Tan Tock Seng Hospital

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