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临床试验/NCT02507193
NCT02507193已完成不适用

Fibular Fixation in Ankle Fractures: a Randomized-Controlled Trial Comparing Plating Versus Intramedullary Nailing

Orlando Health, Inc.2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2015年7月最近更新:
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
51
试验地点
2
主要终点
Functional outcome using the Olerud-Molander score.

研究概览

简要总结

The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation.

详细描述

The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation. This objective will be accomplished using the Olerud-Molander score, a commonly accepted functional outcome score used to evaluate patients post-operatively who have undergone foot and ankle procedures. It is a survey that evaluates patient reported outcomes including pain, stiffness, swelling, stair climbing, running, jumping, squatting, use of supports, and work/activities of daily living (ADL) level. It does not involve physician-measured outcomes. The best possible score is a total of 100. Patients will be given a form to complete throughout follow-up and be utilized for data analysis. Functional outcome will be analyzed with regards to type of fracture, gender, cause of fracture, and affected side to determine if these factors are responsible for any difference.

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
Single (Participant)

入排标准

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

入选标准

  • Distal fibula fracture
  • Pilon fractures
  • Open fractures
  • Ipsilateral foot

排除标准

  • Weber A distal fibula fractures
  • Pathologic fractures

研究组 & 干预措施

Open reduction internal fixation(ORIF)

Active Comparator

This surgical intervention is performed using a plate and screws.Under general anesthesia, an incision is made at the site of the break or injury, and the fracture is carefully re-aligned . The plate and screws are installed, and the incision is closed with staples or stitches. Synthes and Stryker plate and screws will be used.

干预措施: Open reduction internal fixation (Procedure)

Intermedullary (IM) Nail

Active Comparator

This surgical intervention is performed using an intermedullary nail. Under general anesthesia, an incision is made at the site of the break or injury, and the fracture is carefully reduced. The nail in inserted through the medullary canal after proper imaging for accurate placement. The incision is closed with staples or stitches. Acumed fibula nail will be used.

干预措施: Intermedullary Nail (Procedure)

结局指标

主要结局

Functional outcome using the Olerud-Molander score.

时间窗: One year.

The Olerud-Molander score is as assessment of symptoms after ankle fracture.

次要结局

未报告次要终点

研究者

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

Paula J. Harriott

Clinical Research Coordinator

Orlando Health, Inc.

研究点 (2)

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