Diagnostic Study of Lateral Ligament Complex Injury of Ankle

Recruiting

• Conditions: Chronic Instability of Ankle Joint; Lateral Ligament Complex Injury of Ankle
• Interventions: Diagnostic Test: Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy

• Registration Number: NCT04455386
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle

Detailed Description

Background: The lateral ligament complex of ankle joint consisting of the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain, swelling and other symptoms, but also can lead to chronic lateral ankle instability, and osteoarthritis, which could seriously affect the joint motor function.

Method and objective: This study is a prospective diagnostic test. By comparing the sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and characteristics of different diagnostic methods of lateral chronic ankle instability, We aim to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-28
• Study First Posted: 2020-07-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.

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Exclusion Criteria

• Acute and subacute injury of the lateral ligament complex of the ankle joint (less than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage IV).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
slightly instable	Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy	The anterior drawer test and/or talar tilt test are slightly positive and the ankle joint is partially instable.
obviously instable	Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy	The anterior drawer test and/or talar tilt test is significantly positive, with significantly instable. The ankle joint is completely instable and can featured with dimple sign.
stable	Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy	The anterior drawer test and/or talar tilt test are negative and the ankle joint is stable.

Primary Outcome Measures

Name	Time	Method
anterior talar translation and talar tilt	before operation	Assess the instability through stress X ray of the ankle
length of ATFL and CFL in relax and stress position	before operation	Assess the instability through Ultrasound of the ankle
Morphology of ATFL and CFL	before operation	Assess the ATFL and CFL through MRI of the ankle
status of ATFL and CFL	during operation	evaluation of ATFL and CFL during operation

Secondary Outcome Measures

Name	Time	Method
avulsion fracture	before operation	avulsion fracture found by X ray, Ultrasound, CT or MRI
osteophyte	before operation	osteophyte found by X ray, Ultrasound, CT or MRI

Trial Locations

Locations (1)

Institute of Sports Medicine; 🇨🇳 Beijing, Beijing, China