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临床试验/NCT07539922
NCT07539922招募中不适用

Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures

Sohag University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年2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
招募中
入组人数
10
试验地点
1
主要终点
union of lateral malleolar fracture

研究概览

简要总结

The aim of this prospective clinical trial study is to evaluate the clinical and radiological outcomes of treating non-union of the lateral malleolar ankle fractures by double compression screw fixation technique.

详细描述

Fractures involving the lateral malleolar are among the most frequent injuries to the lower extremity, commonly occurring as part of ankle injuries due to twisting mechanisms, falls, or sports-related trauma . These fractures are typically treated effectively with conservative management in stable cases or operative fixation in unstable or displaced patterns. Internal fixation using plate and screw constructs remains the gold standard for displaced fractures, especially when associated with syndesmotic injury or disruption of the ankle mortise . Despite favorable outcomes, complications such as delayed union and nonunion, although relatively rare in the lateral malleolar fractures, can present significant management dilemmas. Non-union refers to the failure of a fracture to heal within an expected time frame and may be classified as hypertrophic (due to inadequate stability) ,atrophic (due to impaired biological activity), oligotrophic or septic non-union .

Risk factors contributing to non-union include inadequate fixation, poor vascularity, infection, smoking, diabetes, and patient non-compliance. When nonunion occurs at the lateral malleolar, it may result in persistent lateral ankle pain, instability, mechanical dysfunction, altered gait mechanics, and decreased quality of life .

The lateral malleolus plays a critical role in maintaining ankle stability and congruity. It serves as a lateral buttress, resisting talar shift and external rotation.

A non-united fibular fracture, especially in the distal third, can disrupt this alignment and compromise the overall biomechanics of the ankle joint . Therefore, surgical intervention is typically warranted in symptomatic non-unions to restore anatomical alignment, re-establish joint stability, and facilitate bony healing Various surgical options have been described for the treatment of lateral malleolar non-unions, including open reduction and internal fixation (ORIF) with plate constructs, bone grafting (autograft or allograft), intramedullary fixation, and, in some cases, external fixation. While plate fixation provides strong stability, it is associated with soft tissue irritation, increased surgical exposure, and potential wound complications, especially in the distal fibula where soft tissue coverage is limited .

In contrast, intramedullary or percutaneous fixation methods, such as the use of compression screws, offer a less invasive approach with reduced morbidity and satisfactory biomechanical outcomes in selected cases . The double compression screw technique provides rigid fixation with minimal hardware prominence and soft tissue disruption. By achieving interfragmentary compression along the fracture line, this method enhances stability and promotes biological healing, making it a suitable option for treating select cases of fibular non-union, particularly in non-comminuted fractures and in patients where soft tissue preservation is essential .

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 65 years.
  • Both sexes.
  • Transvers, non-united Weber type A Lateral Malleolar ankle fracture classification
  • Non-union classified as atrophic, oligotrophic, or hypertrophic
  • Radiologically confirmed non-union of distal fibular fracture (failure to unite after ≥ 6 months post-injury).
  • Adequate bone stock on radiographs/CT suitable for screw fixation.

排除标准

  • Active or previous osteomyelitis or local infection at the fracture site.
  • Pathological fractures.
  • Non-union with gross deformity or significant bone loss requiring complex reconstruction or bone transport

研究组 & 干预措施

patient with symptomatic non-union of lateral malleolar ankle fractures

Experimental

干预措施: Double Compression Screw Fixation for Symptomatic Non-union of Lateral Malleolar Ankle Fractures (Procedure)

结局指标

主要结局

union of lateral malleolar fracture

时间窗: 12 weeks postoperative

Serial radiographs will be obtained at 2, 6, and 12 weeks postoperatively to assess union and screw position. Union will be confirmed by the presence of bridging trabeculae across the fracture site and resolution of fracture lines.

次要结局

  • absence of pain(12 weeks postoperative)
  • foot function and range of motion(12 weeks postoperative)

研究者

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

Muhammed Mahmood Muhammed Ahmed

orthopedic resident

Sohag University

研究点 (1)

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