NCT04826289

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
580

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 29, 2021

Last Update Submit

March 30, 2021

Conditions

Ankle Fractures

Keywords

Radiological standard f ankle fixation

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Interventions

X raysRADIATION

Radiological assessment of vertical distance between medial and lateral malleolus in normal opulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective cross sectional study

You may qualify if:

  • 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

You may not qualify if:

  • people with fracture ankle (United \&non United) Arthritic ankle Diabetic people Abnormal ankle X-rays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Lotfy Makin

Asyut, 75151, Egypt

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Michael Lotfy

    Resident of orthopedic surgery at assiut university

    STUDY CHAIR

Central Study Contacts

Michael Lotfy

CONTACT

01060189840michaelmakin92@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

April 1, 2021

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

EG(1)