Ankle FracturesNCT04826289
Vertical Distance Between Medial and Lateral Malleolus in Normal Population
An observational study of Ankle Fractures, run by Assiut University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- X rays
- Type of treatment
- Surgery or procedure
- How many people
- 580 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Prospective cross sectional study
Who may be able to join
- 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
Who cannot join
- people with fracture ankle (United \&non United) Arthritic ankle Diabetic people Abnormal ankle X-rays
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Ankle Fractures
- Being tested
- X rays
- Keywords
- Radiological standard f ankle fixation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X raysRadiation
Radiological assessment of vertical distance between medial and lateral malleolus in normal opulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical distance between medial and lateral malleolus Radiologically
•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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Lotfy Makin, Assiut University
- Investigators
- Michael Lotfy, Study chair, Resident of orthopedic surgery at assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826289
- Sponsor's protocol ID
- Distance in normal ankle X-ray
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Assessment of Vertical Distance Between Medial and Lateral Malleolus in Normal Population
- ClinicalTrials.gov ID
- NCT04826289
- Acronym / sponsor ID
- Distance in normal ankle X-ray
- Conditions
- Ankle Fractures
- Keywords
- Radiological standard f ankle fixation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Prospective cross sectional study
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- people with fracture ankle (United \&non United) Arthritic ankle Diabetic people Abnormal ankle X-rays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X raysRadiological assessment of vertical distance between medial and lateral malleolus in normal opulation | Radiation | – |
Primary outcome
Vertical distance between medial and lateral malleolus Radiologically
Time frame: 1 year
•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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lotfy study chair
Resident of orthopedic surgery at assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Lotfy (01060189840, michaelmakin92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical distance between medial and lateral malleolus Radiologically (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.