Diagnostic Study of Lateral Ligament Complex Injury of Ankle

April 6, 2023 updated by: Guo Qinwei, Peking University Third Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Institute of Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic lateral ligament complex injury of the ankle were divided into 3 groups and each group with 25 cases, according to the anterior drawer test and talar tilt test.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
stable
The anterior drawer test and/or talar tilt test are negative and the ankle joint is stable.
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.
slightly instable
The anterior drawer test and/or talar tilt test are slightly positive and the ankle joint is partially instable.
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.
obviously instable
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
avulsion fracture
Time Frame: before operation
avulsion fracture found by X ray, Ultrasound, CT or MRI
before operation
osteophyte
Time Frame: before operation
osteophyte found by X ray, Ultrasound, CT or MRI
before operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

June 28, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU-GUO-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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