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临床试验/NCT07447336
NCT07447336尚未招募不适用

Fixation of Lateral Malleolus in Danis_Weber A&B Ankle Fracture by Plate Versus Intramedullary Screw: A Comparative Study

Sohag University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年3月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
试验地点
1
主要终点
compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation

研究概览

简要总结

The aim of this study is to compare the short term :

Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation

详细描述

The aim of this study is to compare the short term :

Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants selected randomly

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Displaced , unstable lateral malleolar fractures Weber type A or B,
  • either isolated or associated with medial or posterior malleolar fractures .
  • Age group : [18_60 years old Patients]
  • Male or female patient

排除标准

  • 1. Associated syndesmotic injury
  • 2open fractures
  • neuropathic disorders
  • paralytic disorders
  • 5 Osteoporotic fractures
  • Patients with uncontrolled diabetes
  • 7 Comminuted fractures

研究组 & 干预措施

Group (A) : plate fixation for lateral malleolus fracture

Active Comparator

fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate(Group A) versus intramedullary screw fixation (Group B)

干预措施: Fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation (Procedure)

结局指标

主要结局

compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis_Weber_A&B fracture ankle by plate versus intramedullary screw fixation

时间窗: 4months,6months,9months,1year after treatment

compare the short term : Clinical, radiographic and functional outcome, and healing time and rate of complications between fixation of lateral malleolar fracture in Danis\_Weber\_A\&B fracture ankle by ORIF and plate fixation versus intramedullary screw fixation .Study will occur at Orthopaedics and Traumatology department Sohag University Hospitals .Study will be done on about 52 participants Functional outcome evaluated by Manchester\_Oxford Foot Questionnaire(MOXFQ) scoring system: comprises three dimensions (pain, standing/walking, social interaction ) and also by VAS(Visual Analogue score)is a 10-cm ( ) straight line used to measure subjective intensity of pain, fatigue, or mood, with 0 representing "no pain" and 10 or 100 representing "worst imaginable pain" American Orthopaedic Foot and Ankle Society (AOFAS) score is a 100-point clinical rating system (0-100, with higher being better) designed to evaluate pain (40 pts), function (50 pts), and alignment (10 pts) for foot and ankle

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

Ahmed Mohamed Hemdan

Resident at Orthopaedics and Trauma department Sohag University Hospitals

Sohag University

研究点 (1)

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