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临床试验/NCT07315581
NCT07315581已完成不适用

Does Age Matter? Outcomes of Pilon Fracture Fixation in Patients Above and Below 40 Years: A Comparative Study

Cairo University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Healing rate

研究概览

简要总结

Pilon fractures are severe intra-articular injuries in the distal tibial plafond that result primarily from high-energy axial compression mechanisms such as road traffic accidents or falls from height [1]. They constitute 1-10% of all tibial fractures and frequently involve significant comminution and compromise of the soft-tissue envelope [1,2]. Successful management requires anatomical reduction of the articular surface, restoration of limb alignment, and careful protection of the soft tissues [3].

Since the first description of open reduction and internal fixation (ORIF) for Pilon fractures by Rüedi and Allgöwer in 1969, surgical protocols have evolved from single-stage fixation to a more conservative two-stage approach to reduce wound complications [4-6]. Despite technical advances, treatment outcomes can vary depending on patient-specific factors such as age, comorbidities, and bone quality [7,8].

Younger patients generally exhibit higher bone density and faster healing potential, while patients above 40 years may experience delayed union, increased risk of infection, and reduced functional recovery due to poorer bone perfusion and degenerative changes [9-11]. However, there is limited comparative data examining the impact of age on the success of ORIF in Pilon fractures.

The current study aims to compare clinical and radiographic outcomes of ORIF in patients below and above 40 years, analyzing differences in union rate, complications, and functional recovery using standardized scoring systems.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Closed, fracture
  • Complete articular fracture
  • Neither 43-C1, 43-C2, or 43-C3 types based on OTA/AO classification

排除标准

  • Open fractures
  • Pathological fractures
  • Acute compartment syndrome

结局指标

主要结局

Healing rate

时间窗: 6 months postoperatively

Number of cases in which complete healing was achieved

次要结局

  • AOFAS(2 YEARS postoperatively)
  • OMS(2 YEARS postoperatively)
  • Complications rate(2 years postoperatively)

研究者

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

Mahmoud Ahmed El-Desouky

Associate Professor of Orthopedic Surgery

Cairo University

研究点 (1)

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