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临床试验/NCT04459910
NCT04459910已完成不适用

Medial and Lateral Combined Ligament Arthroscopic Repair for Multidirectional Ankle Instability: Case Series

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年7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
29
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

Abstract Introduction: The high prevalence of sprains in the population has provided a substantial number of patients with lateral instability of the ankle. The continuity of this condition can lead to the progressive loosening of the medial containment structures, generating a multidirectional rotational instability. The deltoid approach through the imbrication of its components has been proposed as a solution for these patients. The arthroscopic technique has been described as an alternative.

Methods: This is a retrospective study with patients diagnosed with multidirectional instability and submitted to an ankle arthroscopy with medial repair (arthroscopic tensioning) and lateral (arthroscopic Brostrom) 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 combined medial and lateral arthroscopic repair may be an effective and safe alternative in the treatment of multidirectional instability. 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.

Design: Level IV. Retrospective case series.

Keywords: ankle injuries; lateral ligament; collateral ligaments; joint instability

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

入选标准

  • complaints about ankle loosening for the last six months
  • clinical findings of lateral and medial instability

排除标准

  • existence of previous surgery
  • autoimmune diseases
  • neuropathy
  • inflammatory disease
  • isolated medial instability
  • previous ankle infiltration
  • radiographic findings of ankle arthritis
  • cavovarus deformity
  • coagulopathies
  • body mass index over 35
  • associated injuries, such as osteochondral lesions
  • syndesmosis instability
  • tendon ruptures
  • fractures

结局指标

主要结局

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

时间窗: 6th post-operataive month

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

次要结局

  • Visual Analogue Scale (VAS)(6th post-operataive month)
  • Complications(6th post-operataive 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

MD, PhD

Federal University of São Paulo

研究点 (1)

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