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临床试验/NCT04473638
NCT04473638已完成不适用

Deltoid Ligament Arthroscopic Repair in Ankle Fractures: Case Series

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8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
20
试验地点
1
主要终点
American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)

研究概览

简要总结

To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

详细描述

Introduction

The diagnosis and treatment of ankle medial ligament lesions in malleolar fractures have always been surrounded by controversies. Even in the certainty of deltoid involvement and its consequent instability, the direct repair of this structure is not a consensus. In recent years, the arthroscopic technique to approach this ligament has been described with the objective of potentiating clinical results and minimizing possible complications.

Objective

To demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

Methods: This is a retrospective study in patients diagnosed with ankle fractures associated with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic repair between January 2018 and January 2020. All patients will fill an epidemiological questionnaire and will be evaluated for pain and function according to the Visual Analogue Scale (VAS) and the American Orthopaedic Foot and Ankle Society Score (AOFAS) at 12 months (6-24 months) average of follow-up.

Discussion: The inclusion of the deltoid complex and the low invasiveness of this technique can improve the clinical outcomes of these patients. Additional studies, with a prospective and comparative methodology are required to sustain this proposal.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • acute (less than two weeks) ankle fracture containing a medial ligament injury suspicion will be included. Syndesmotic lesion with a deltoid association will also be addressed

排除标准

  • previous surgery
  • autoimmune diseases
  • neuropathy
  • inflammatory diseases
  • radiographic preoperative findings of ankle arthritis
  • open medial wound
  • coagulopathies
  • any other condition that would contraindicate surgery

结局指标

主要结局

American Orthopedic Foot and Ankle Society - Hindfoot Score (AOFAS)

时间窗: Time Frame: 6th post-operative month

Functional Score (0 to 100 \| 100 best score possible \| 0 worst score possible)

次要结局

  • Visual Analogue Scale (VAS)(Time Frame: 6th post-operative month)
  • Number of Complications related to Treatment(6th post-operative month)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nacime Salomão Barbachan Mansur

Principal Investigator

Federal University of São Paulo

研究点 (1)

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