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临床试验/NCT02599285
NCT02599285Unknown不适用

Operative Treatment of AO Weber C Fibular Fractures With Additional Medium-sized Posterior Malleolar Fragment: Syndesmotic Reduction and Functional Outcome After Syndesmotic Positioning Screws or Posterior Fragment Fixation. POSTFIX-C Trial: a Prospective Comparative Observational Study.

Medical Center Haaglanden4 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
54
试验地点
4
主要终点
Accuracy of syndesmotic reduction 1cm above the tibial plafond, measured on post-operative CT-scan in millimeters compared to the contralateral (healthy) side.

研究概览

简要总结

In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial fracture or ruptured deltoid ligament, and a syndesmotic injury. Anatomical repair and reduction of the syndesmosis is essential to prevent diastasis in the ankle-joint. Widening and chronical instability of the syndesmosis is related to worse functional outcome and development of posttraumatic osteoarthritis in the ankle. There is limited biomechanical and clinical evidence that syndesmotic stability in AO Weber type C fractures with an additional posterior malleolar fracture can also be reached by fixation of the posterior malleolar fragment. Maybe, this is even superior to the usual treatment with syndesmotic positioning screws. Some authors concluded that stability of the syndesmosis in these fractures can be much more achieved by fixation of the posterior malleolar fragment than by placement of syndesmotic positioning screws alone. Another additional benefit of open reduction and fixation of the posterior malleolar fragment is that this will lead to an anatomical reconstruction of the syndesmosis. Although there is no current evidence, it is likely that a malreduction of the fibula in the tibial incisura will lead to a worse functional outcome on the long-term. No clear consensus in the literature is found as to which fragment size of the posterior malleolus should be internally fixed. The general opinion is that displaced fragments that involve more than 25% of the distal articular tibia should be fixed. Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve an anatomical reduction, and that percutaneous fixation of smaller fragments is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach in prone position, followed by open reduction and fixation with screws in posterior-anterior direction or antiglide plate is advocated by several authors. This approach allows perfect visualization of the fracture, articular anatomical reduction, and strong fixation. Another advantage is that even small posterior fragments can be addressed. Several case series are published, which describe minimal major wound complications, good functional outcomes, and minimal need for reoperation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Age between 18 and 70 years
  • First ankle fracture of the affected side
  • Isolated, fibular fracture proximal to the syndesmosis with a posterior malleolar fragment between 5 and 25% of the involved articular surface(AO type 44-C1, 44-C2, 44-C3).

排除标准

  • Multiple injuries
  • Ankle fracture of the same ankle in the history
  • Patients with pre-existent mobility problems
  • Pre-existent disability like wheelchair or walking aid dependency.
  • Patients living in another region of whom follow-up will take place in another hospital
  • Insufficient understanding of the Dutch language

结局指标

主要结局

Accuracy of syndesmotic reduction 1cm above the tibial plafond, measured on post-operative CT-scan in millimeters compared to the contralateral (healthy) side.

时间窗: 1 year

Functional outcome measured by AAOS score (special questionnaire for hindfoot and ankle in 27 questions.)

时间窗: 1 Year

次要结局

  • Posttraumatic osteoarthritis defined by the Kellgren-Lawrence score (1-4)(5 Years)

研究者

发起方
Medical Center Haaglanden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jochem Hoogendoorn

Dr.

Medical Center Haaglanden

研究点 (4)

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