- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695965
Magnetic Resonance Imaging Evaluation of Lateral Ankle Instability
October 3, 2018 updated by: Ahmed Mohamed Abbas, Assiut University
Lateral ankle instability may be acute or chronic.
Acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament.
Most ankle ligamentous injuries are treated conservatively.
However, 20% to 40% of patients complain of chronic instability and persistent discomfort.
Structural instability, loss of proprioceptive capabilities, and the weakness of peroneal muscles seem to induce chronic instability
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
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
patients with history of ankle trauma or chronic lateral ankle pain that will be evaluated using magnetic resonance imaging.
Description
Inclusion Criteria:
- Patients with any sex, age, complaining of chronic lateral ankle pain.
Exclusion Criteria:
- Tumors at ankle region.
- Postoperative status around the ankle.
- Rheumatoid arthritis.
- Comminuted fracture at the ankle.
- Congenital anomalies of the ankle.
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 |
---|---|
study group
patients with history of ankle trauma or chronic lateral ankle pain
|
1.5 Tesla magnet system is going to be utilized for ankle imaging.
A dedicated extremity surface coil (Foot/Ankle 16-Channel Coil; Siemens Medical Solution) is used to enhance spatial resolution.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patients with ankle or ligaments abnormalities by examination
Time Frame: 30 minutes
|
Magnetic resonance imaging examination will be the method for diagnosis
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2018
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
October 3, 2018
First Submitted That Met QC Criteria
October 3, 2018
First Posted (Actual)
October 4, 2018
Study Record Updates
Last Update Posted (Actual)
October 4, 2018
Last Update Submitted That Met QC Criteria
October 3, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRILAI
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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