跳至主要内容
临床试验/NCT04301037
NCT04301037已完成不适用

Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture: Randomized Comparative Study

Hawler Medical University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Modified Olerund and Molander scoring system

研究概览

简要总结

This is a prospective randomized study conducted on 30 patients with an age spanning between 20 and 55 years. Half of the sample was treated by tension band wiring for closed medial malleolar fractures, and the other half by two cannulated screws. The patients were assessed at (6w-3months and 6months) for clinical and radiological union and evaluated functionally (12 months) using modified Olerund and Molander scoring system.

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
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 20-55 years.
  • Isolated or bimalleolar ankle fractures.
  • Closed fractures.

排除标准

  • Patient with poor bone quality on x ray (radiological osteopenia, thinning of the cortices, loss of trabecular definitions and previous insufficiency fractures)
  • Type D isolated medial malleolus, supination adduction (vertical malleolar) fractures.
  • Comminuted fractures.
  • Skeletally immature patients.

结局指标

主要结局

Modified Olerund and Molander scoring system

时间窗: The functional outcome was measured in all patient 12 months after surgery

Ankle functional outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherwan Ahmed Ali Hamawandi

Assistant professor of orthopedic surgery

Hawler Medical University

研究点 (2)

Loading locations...

相似试验