- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04826289
Vertical Distance Between Medial and Lateral Malleolus in Normal Population
March 30, 2021 updated by: Michael Lotfy Makin, Assiut University
Radiological Assessment of Vertical Distance Between Medial and Lateral Malleolus in Normal Population
Determine variation in vertical distance between the medial and lateral malleolus in the normal population subjected to X-rays for any other causes than ankle fracture Determine the effect of weight bearing on this variation
Study Overview
Detailed Description
There is gap of knowledge about determination of vertical distance between medial and lateral malleolus Our research will cover this gap of knowledge ,so our research question will be what is the normal variation of vertical distance between medial and lateral malleolus Fractures of ankle are common injuries,approximately 2% of the general population will sustain an ankle fracture during their life time .many
can be successfully treated non operatively However,for those injuries that require surgical intervention ,restoration of the anatomy is the main principle The importance of anatomic restoration of the fibula ,specially in preserving normal length has been appreciated by several authors Data will be obtained from measuring the vertical distance between lateral and medial malleolus in AP view of ankle in traumatic non ankle fractured people in standing and non standing position
Study Type
Observational
Enrollment (Anticipated)
580
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
- Name: Michael Lotfy
- Phone Number: 01060189840
- Email: michaelmakin92@yahoo.com
Study Locations
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Assiut, Egypt, 75151
- Michael Lotfy Makin
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Contact:
- Michael Lotfy, Resident
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Prospective cross sectional study
Description
Inclusion Criteria:
- non ankle fractured people Non arthritic ankle Age more than 18 years old Non diabetic people Normal ankle X-rays as determined by tibiocrural angle and tibiofibular overlap
Exclusion Criteria:
- people with fracture ankle (United &non United) Arthritic ankle Diabetic people Abnormal ankle X-rays
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertical distance between medial and lateral malleolus Radiologically
Time Frame: 1 year
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•All ankle X rays will be collected periodically through the PAC system (in Emergency Room and out patient clinics )•Using talocrural angle and tabiofibular overlapping to verify normal ankle anatomy as well as exclusion of those X rays in exclusion criteria
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Michael Lotfy, Resident of orthopedic surgery at assiut university
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 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
March 30, 2021
First Posted (Actual)
April 1, 2021
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 30, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Distance in normal ankle X-ray
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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