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临床试验/NCT04095598
NCT04095598招募中不适用

Comparative Computed Tomography with Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability in Adults After Acute Ankle Sprain: a Test Accuracy Study

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
133
试验地点
1
主要终点
Tibiofibular distance

研究概览

简要总结

The main aim of this study was to investigate which strategy can diagnose more accurately syndesmotic instability among an existing index test (ankle CT in neutral position) and two new add-on index tests (ankle CT in a stress position with extended-knees and ankle CT in a stress position with flexed-knees). This study hypothesized that the two add-on ankle CT with stress maneuvers (CTSM) have a more accurate capability of diagnosing syndesmotic instability than ankle CT in a neutral position (CTNP) alone. The secondary objective is to investigate the participants' disability outcomes by applying the Foot and Ankle Ability Measure questionnaire.

详细描述

INTRODUCTION:

One specific type of sprain is a high ankle sprain with ligament damage to the distal tibiofibular syndesmosis. A syndesmotic lesion is the leading cause of persistent disability or chronic pain and frequently requires longer recovery times and receives significantly more treatments than low lateral ankle sprains.

The degree of instability in syndesmotic disruption guides the decision to operate or treat conservatively. Clinical examinations, routine radiographs, stress radiographs, computed tomography (CT), and magnetic resonance imaging (MRI) are the available diagnostic tools to decide the correct treatment. Unfortunately, the clinical diagnosis has limited evidence. The best current practice considers that few clinical examination tests have some validity in identifying syndesmotic disruption. The mortise or anteroposterior radiographic view may promptly diagnose frank syndesmotic instability (SI), identifying the widening of the articular space on the injured side relative to the contralateral uninjured side. However, SI may be underdiagnosed when routine radiography shows a healthy articular relationship. Routine radiographs cannot reliably predict syndesmotic injuries. Stress radiographs are inaccurate for evaluating such injuries in a cadaveric model. CTNP is more sensitive than radiography for detecting syndesmotic widening. MRI can be used to visualize and diagnose damaged ligaments with high accuracy.

Notwithstanding, the traditional measurement of the anterior tibiofibular distance (ATFD), obtained by CTNP, has an unsatisfactory area under the receiver operator curve (ROC) performance of 0,58 in diagnosing SI. Despite all these available methods, SI is still challenging to diagnose correctly, and syndesmotic ligament disruption and real SI should be differentiated. CTSM is an alternative approach that could improve the diagnosis of SI. To the investigator's knowledge, the application of CTSM has not been previously described.

METHODS:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Tibiofibular distance

时间窗: Through the study completion, a average of three years

Measurements of the tibiofibular distance

次要结局

  • Interobserver CT agreement reliability(Through the study completion, a average of three years)
  • Interobserver MRI agreement reliability(Through the study completion, a average of three years)
  • Foot and Ankle Ability Measurement(Change from 6 months to 12 months)

研究者

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

Joao Carlos Rodrigues

Physician

Hospital Israelita Albert Einstein

研究点 (1)

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