Assessment of Accuracy of Ultrasonography in Diagnosis of Non-osseous Lateral Ankle Instability in Comparison With Magnetic Resonance Imaging

April 4, 2021 updated by: Marina Raafat Fouad, Assiut University
Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Approximately 74% of acute ankle sprains result in persistent symptoms, 30% of which progress to chronic ankle instability. Arthroscopic examination and magnetic resonance imaging (MRI) are considered the two most accurate methods of diagnosing injuries to lateral collateral ligaments. Ultrasound has been proven able to detect soft tissue injuries, However, the use of ultrasound and its' ability to accurately diagnose CAI is still under debate. The aim of this study is to investigate the diagnostic accuracy of ultrasonography for the assessment of non-osseous lateral ankle instability in comparison with magnetic resonance imaging (MRI).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic ankle instability (CAI) is a condition that often develops after repeated ankle sprains, increasing the susceptibility of the ankle to move into excessive inversion when walking on unsteady surfaces. Approximately 74% of acute ankle sprains result in persistent symptoms, 30% of which progress to chronic ankle instability.[1-3] CAI is diagnosed in individuals who report pain and tenderness on the lateral aspect of the ankle, or persistent swelling and discomfort for greater than six months with a history of re-injury or clinical instability of the ankle joint.[4, 5] The primary cause of damage to the structural stability of the ankle joint is trauma by forced inversion and plantarflexion. The lateral collateral ligaments, which are more commonly affected by acute sprains, include the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL). The ATFL is primarily responsible for preventing excessive supination and anterior translation, while also restricting plantar flexion and internal rotation.

Common diagnostic tools used to identify ankle instability include clinical testing (like Anterior Drawer Test), imaging and arthroscopy. Arthroscopic examination and magnetic resonance imaging (MRI) are considered the two most accurate methods of diagnosing injuries to lateral collateral ligaments. [7] In a retrospective study conducted by Joshy et al., in which 24 patients underwent arthroscopy and MRI of the ankle, MRI was found to have both high specificity (100%) and high sensitivity (100%) for ATFL disruption. [8-10] Ultrasound has been proven able to detect soft tissue injuries, and has even become the gold standard for the detection of injuries to the patellar and Achilles tendons. [2, 11] However, the use of ultrasound and its' ability to accurately diagnose CAI is still under debate.

When imaging the ankle, ultrasound should be able to detect synovial lesions, ligamentous injury, and distinguish soft tissue from osseous impingement.[8] Dynamic ultrasound should be also used to discover dislocation of the peroneal tendons, or intra-sheath dislocation, which is indicated by an intact retinaculum with subluxation of the peroneal tendons within the groove.[11] Aim of the work: The aim of this study is to investigate the diagnostic accuracy of ultrasonography for the assessment of non-osseous lateral ankle instability in comparison with magnetic resonance imaging (MRI).

Patients and Methods:

fifty four patients complaining of acute or chronic lateral ankle instability will be included in this study.

Inclusion criteria:

Patients complaining of acute or chronic lateral ankle instability.

Exclusion criteria:

  • Previous ankle surgery
  • Interventional intra-articular procedures (previous arthroscope, injections)
  • Systemic inflammatory disorders (collagen diseases)
  • Diagnosed osseous lesions.

Methods:

All patients will be subjected to:

Thorough history taking and clinical provisional diagnosis. Plain X-ray of the affected ankle in AP and lateral views to exclude any osseous lesions.

Real-time high resolution ultrasonography of the affected ankle joint MRI for the affected ankle joint.

Ultrasound Technique:

The ultrasonographic examination of the ankle begins with the patient in supine position. Longitudinal scanning of the ankle was first performed to get an overall view of the tibio-talar joint and to detect joint effusion. Thereafter, slight inversion of the foot is performed while the patient in the same position to examine the lateral collateral ligaments and peroneal tendons. The Anterior talo-fibular ligament (ATFL) is first examined in oblique transverse plane from the tip of lateral malleolus, antero-medially and slightly downward, till the talus. Then, the Calcaneo Fibular ligament (CFL) is examined in oblique longitudinal plane from the lateral malleolar tip downward and slightly backward to the lateral surface of the calcaneus.

Regarding the peroneal tendons, they are examined from their supra-malleolar musculo-tendinous junction, and then just behind the lateral malleolus till their infra-malleolar course in both longitudinal and transverse planes.

MRI examination All patients will have MRI imaging of the affected ankle(s) on a high field-strength scanners.

Positioning:

Every patient lies supine with the ankle and foot in neutral position and plantar flexion of 20-30 degrees for reducing the "magic angle" artifact. No movement allowed during examination by supporting the ankle using pads.

Protocol:

The patients are examined by different pulse sequences including T1, T2, proton density, gradient echo and STIR. The examinations will be done in different planes.

Our usual protocol of examination is Sagittal T1WIs, Axial T1WIs T2WIs and proton density images, coronal T1WIs as well as Sagittal or coronal STIR.

Other parameters applied include slice thickness ranged from 3 to 5 mm, matrix 256/192 or 512/224, number of excitation 2 to 3 and field of view ranged from 12 to 16 cm, better kept <14 cm.

Study Type

Observational

Enrollment (Anticipated)

54

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
      • Assiut, Egypt, 71511
        • Recruiting
        • Mariana Raafat Fouad
        • Contact:
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

fifty four patients complaining of acute or chronic lateral ankle pain and instability will be included in this study.

Description

Inclusion Criteria:

  • Patients complaining of acute or chronic lateral ankle pain and instability.

Exclusion Criteria:

  • Previous ankle surgery
  • Interventional intra-articular procedures (previous arthroscope, injections)
  • Systemic inflammatory disorders (collagen diseases)
  • Diagnosed osseous lesion

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

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.
Time Frame: 1 year
To study the accuracy, sensitivity and specificity of Ultrasonography in assessment of lateral ankle disorders causing ankle instability and pain in comparison to MRI.
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Mariana Raafat, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

April 3, 2021

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

March 30, 2022

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 4, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17100620

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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