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临床试验/NCT02801474
NCT02801474已完成不适用

Surgical Management of Posterior Malleolar Fractures Using the Direct or Indirect Reduction Techniques

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
148
试验地点
1
主要终点
American Orthopaedic Foot and Ankle Society ankle-hindfoot score

研究概览

简要总结

Patients with a posterior malleolar fracture were recruited and assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation of the fracture, the quality of fracture reduction was evaluated in radiograph and CT images. Functional outcome was evaluated at the last follow-up.

详细描述

Patients with a posterior malleolus fracture were recruited meeting the inclusion criteria of unstable and displaced posterior malleolar fractures requiring surgical management. Patients with open fractures or pathological fractures were excluded. Preoperative anteroposterior (AP), lateral, and mortise view radiographs as well as computed tomography (CT) scans were routinely obtained to evaluate the characteristic of the fracture. Patients were then assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation of the fracture using the direct reduction technique or the indirect reduction technique, the quality of fracture reduction was evaluated in radiograph and CT images. Functional outcome,including AOFAS score, ankle range of motion were evaluated at the last follow-up.

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

入选标准

  • unstable ankle fracture requiring surgical intervention
  • with posterior malleolar fracture

排除标准

  • open fractures
  • pathological fractures

结局指标

主要结局

American Orthopaedic Foot and Ankle Society ankle-hindfoot score

时间窗: 1 year

次要结局

  • ankle range of motion in degrees(1 year)
  • residual displacement of the posterior malleolus in mm(3 days postoperatively)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin XIONG

Director in the Department of Orthopaedics

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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