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临床试验/NCT03170687
NCT03170687已完成不适用

Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

Jatupon Kongtharvonskul2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
VAS

研究概览

简要总结

This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).

详细描述

A randomized controlled trial will conducts between January 2017 and January 2019, participants with acute fifth metatarsal fracture (Zone II) will recruit for this study at the orthopedic outpatient clinic of a police general hospital, Bangkok, Thailand. A total of 100 patients will randomly allocate to receive foot cast or short leg cast. acute closed fracture of proximal fifth metatarsal (zone II) patients.

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
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • acute closed fracture of proximal fifth metatarsal (zone II) with following criteria
  • History of trauma and pain at lateral side of foot
  • Tenderness at base of 5th metatarsal
  • Radiographic finding shown fracture line at proximal 5th metatarsal bone

排除标准

  • more than 1 week
  • comminuted or multiple fracture
  • Open fracture
  • Ligament and tendon injury
  • Previous injury complication: nonunion, delayed union
  • refuse to inform consent

研究组 & 干预措施

foot cast

Experimental

干预措施: short foot cast (Device)

short leg cast

Active Comparator

干预措施: short leg cast (Device)

结局指标

主要结局

VAS

时间窗: 8 weeks

visual analog score

次要结局

  • complication(8 weeks)
  • union rate(8 weeks)
  • AOFAS(8 weeks)

研究者

发起方
Jatupon Kongtharvonskul
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jatupon Kongtharvonskul

clinical doctor in section of clinical epidermiology and biostatistic

Ramathibodi Hospital

研究点 (2)

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