- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06562062
Radiological Outcomes of Modified Extra-articular LCL
August 16, 2024 updated by: Hosam Eldeen Kamal Mohamed, Assiut University
Radiological Outcomes of Modified Extra-articular Lateral Column Lengthening Procedure for Correction of Adult Acquired Flexible Flatfoot Deformity
To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Measurement of
- Calcencal pitch : This angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface(10), normal ranges of between 10-25° and 20-30 have Been proposed(11)
- Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , typically', Meary's angle is 0°, with abnormal values considered angle >4° convex upward: pes cavus , angle <-4 convex downward: pes planus, It can be used to classify the severity of deformity
- lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis , The lateral talocalcaneal angle should normally measure between 25 and 40°, >40° diagnoses flatfoot deformity(12)
- Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface) ,Interpreting the talonavicular coverage angle (13)Normal: <7,Adult Acquired flatfoot disease: >7°
Study Type
Observational
Enrollment (Estimated)
1
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: Hosam Eldeen Kamal Mohamed, Resident
- Phone Number: +201015106584
- Email: Hossam.15235597@med.aun.edu.eg
Study Locations
-
-
Assiuu
-
Assiut, Assiuu, Egypt
- Recruiting
- Faculty of Medicine Assiut University
-
Contact:
- Amr Abo Alfadle, Lecturer
- Phone Number: +201007788699
- Email: Amr.a.mohamed@aun.edu.eg
-
-
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
Yes
Sampling Method
Non-Probability Sample
Study Population
Adult flexible acquired flatfoot deformity which doesn't include genetic or spasmodic flatfoot deformity in children
Description
Inclusion Criteria:
- 1) Age : adult ( age above 16 years old and below 65 years old
2) symptomatic flexible flat foot after failure of Conservative treatment
Exclusion Criteria:
- 1- Age: (<16,>65) years old 2 -Previous foot surgery 3- autoimmune disease
- 4 Uncontrolled blood sugar 5- Osteoprotic patient 6- Infection
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 |
|---|---|---|
|
Radiological outcome & by standard erect plain x ray after 3 months
Time Frame: 3 months after the surgery
|
Measurement of
|
3 months after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
clinical outcome by American orthopedic foot and ankle score (hindfoot
Time Frame: 6 months after the surgery when the patient restore his life activities maximally
|
6 months after the surgery when the patient restore his life activities maximally
|
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 (Estimated)
August 16, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
February 1, 2028
Study Registration Dates
First Submitted
August 16, 2024
First Submitted That Met QC Criteria
August 16, 2024
First Posted (Actual)
August 20, 2024
Study Record Updates
Last Update Posted (Actual)
August 20, 2024
Last Update Submitted That Met QC Criteria
August 16, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Extra-articular LCL of AAFFD
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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