Diagnostic Study of Lateral Ligament Complex Injury of Ankle

Chronic Instability of Ankle Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455386
• Other study ID #: PKU-GUO-02
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Peking University Third Hospital
• Contact: Qinwei Guo
• Phone: 18601129252
• Email: guoqinwei[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

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).

Related Conditions & MeSH terms

• Ankle Injuries
• Chronic Instability of Ankle Joint
• Lateral Ligament Complex Injury of Ankle
• Wounds and Injuries

Intervention

Diagnostic Test:
• Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy
All patients suspected chronic ankle instability, will perform an anterior drawer test, stress ultrasound, computed tomography, magnetic resonance imaging of ankle. Patients with chronic ankle instability will be recommended to perform an arthroscopic repair if non-operative treatment failed.

Locations

Country	Name	City	State
China	Institute of Sports Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anterior talar translation and talar tilt	Assess the instability through stress X ray of the ankle	before operation
Primary	length of ATFL and CFL in relax and stress position	Assess the instability through Ultrasound of the ankle	before operation
Primary	Morphology of ATFL and CFL	Assess the ATFL and CFL through MRI of the ankle	before operation
Primary	status of ATFL and CFL	evaluation of ATFL and CFL during operation	during operation
Secondary	avulsion fracture	avulsion fracture found by X ray, Ultrasound, CT or MRI	before operation
Secondary	osteophyte	osteophyte found by X ray, Ultrasound, CT or MRI	before operation