跳至主要内容
临床试验/NCT06883435
NCT06883435已完成不适用

A Prospective Comparative Study Between Percutaneous Cannulated Screws and Open Reduction and Internal Fixation in Treatment of Displaced Isolated Medial Malleolar Fractures

Sohag University1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2021年4月1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
入组人数
118
试验地点
1
主要终点
AOFAS (American association of foot and ankle society) ankle-hind foot score

研究概览

简要总结

The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures.

详细描述

Medial malleolar (MM) fractures occur in about 50% of all ankle fractures, and may occur as isolated MM fractures or as part of a bi- or tri-malleolar ankle fractures.

MM fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height.

When MM fractures occurring as a part of a bi- or tri-malleolar ankle fractures, MM fractures are typically treated with surgical fixation. Isolated non-displaced MM fractures can be treated conservatively by below knee cast application. Displaced isolated MM fractures are usually treated surgically.

Many fixation techniques for MM fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. The choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. Surgical procedures can be done by open reduction internal fixation (ORIF) or closed reduction percutaneous fixation.

In comparison to an ORIF, a percutaneous approach to MM fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. However, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. Some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult patients with closed, displaced (˃2mm), isolated medial malleolar fractures of Herscovici type B or C.

排除标准

  • •comminuted fractures, open fractures, bi-, tri-, or quadri-malleolar ankle fractures, associated syndesmotic or lateral collateral ligament injuries, skeletally immature patients, any other ipsilateral lower limb fractures, or previously fractured ankle.

研究组 & 干预措施

closed reduction and percutaneous fixation (CRPF)

Experimental

percutaneous cannulated screws fixation of medial malleolus

干预措施: closed reduction and percutaneous fixation of medial malleolus (Procedure)

open reduction and internal fixation (ORIF)

Experimental

Open reduction and screw fixation of medial malleolus

干预措施: open reduction and screw fixation of medial malleolus (Procedure)

结局指标

主要结局

AOFAS (American association of foot and ankle society) ankle-hind foot score

时间窗: Baseline

American association foot and ankle society score for foot and ankle conditions

次要结局

  • Foot and ankle ability measure (FAAM)(baseline)
  • visual analogue scale (VAS)(baseline)

研究者

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

Khalaf fathy elsayed Ahmed

Principal investigator

Sohag University

研究点 (1)

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