- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335459
Epidemiology of Bunion and Risk Factors
March 21, 2024 updated by: Hossam Khaled Mohamed Ahmed, Assiut University
The Epidemiology and Risk Factors of Hallux Valgus in Upper Egypt
Analysis of the collected data to determine:
- Prevalence.
- Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Hallux valgus (HV) is a common foot deformity whose multifactorial and complex and associated with other foot deformities.
It is a common 1st ray deformity characterized by excessive angulation, rotation, and lateral deviation of the great toe at the first metatarsophalangeal joint .
There are many symptoms of HV include poor fitting shoes, plantar foot pain, and pain in the medial first MTP joint .The resultant deformity causes pain and discomfort, which decreases the physical function of the foot and has been identified as a risk factor for falls in older people .
Systematic reviews estimated the prevalence of HV to be more frequent with Old age and is more prevalent in women .
Several risk factors for HV have been identified HV is associates with wearing high-heeled or narrow shoes .
Foot problems are prevalent in old aged and are thought to be associated with high heels and narrow shoes The relationship between HV and obesity is less clear.
Some studies have found an association between HV and increasing body mass index whereas others have found no association.
Most recently, it has been suggested that the association between HV and BMI differs between the genders, with a lower prevalence with increasing BMI in women but no association in men and in Upper Egypt the principle investigator aim to collect data through a cross sectional study to know the prevalence and calculate the percentage of each certain risk factor through AP Standing Foot and evaluate HV angles and determind who has HV and then calaculate the prevalence and determind associated Risk Factors , while collecting cases the principle investigator focus on Emergency Unit on people without Foot Trauma , no neurological deficit and from outpatient clinic
Study Type
Observational
Enrollment (Estimated)
2000
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 Khaled, physion
- Phone Number: 01027931035
- Email: Hossam.15235782@med.aun.edu.eg
Study Contact Backup
- Name: Amr aboelfadle, PhD
- Phone Number: 01007788699
- 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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
randomly taken people 2000 person taken to do AP - Lateral standing position Foot - sessamoid and full History taken with clinical examination and a Questionnaira about knowledge about bunion and if there is past medical seek for help or not
Description
Inclusion Criteria:
- aged (18 - 80) including both sexes Males and Females
- Patients with no Foot trauma or Neurological deficit
Exclusion Criteria:
- Post traumatic Hallux valgus
- post infection Hallux valgus
- Post Surgical Hallux valgus -
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 |
---|---|---|
History taken and well clinical examination and AP Foot standing position of 2000 randomly case with determination of Hallux Valgus angles knowing if It's Hallux Valgus or not calculating The prevalence
Time Frame: baseline
|
Calculate the prevalence of Hallux Valgus by history taken and clinical examination of 2000 cases randomly selected and measuring of Hallux Valgus angles for the participants to know the prevalence
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hecht PJ, Lin TJ. Hallux valgus. Med Clin North Am. 2014 Mar;98(2):227-32. doi: 10.1016/j.mcna.2013.10.007. Epub 2013 Dec 8.
- Steadman J, Barg A, Saltzman CL. First Metatarsal Rotation in Hallux Valgus Deformity. Foot Ankle Int. 2021 Apr;42(4):510-522. doi: 10.1177/1071100721997149. Epub 2021 Mar 25.
- Menz HB, Marshall M, Thomas MJ, Rathod-Mistry T, Peat GM, Roddy E. Incidence and Progression of Hallux Valgus: A Prospective Cohort Study. Arthritis Care Res (Hoboken). 2023 Jan;75(1):166-173. doi: 10.1002/acr.24754. Epub 2022 Aug 31.
- Menz HB, Roddy E, Marshall M, Thomas MJ, Rathod T, Peat GM, Croft PR. Epidemiology of Shoe Wearing Patterns Over Time in Older Women: Associations With Foot Pain and Hallux Valgus. J Gerontol A Biol Sci Med Sci. 2016 Dec;71(12):1682-1687. doi: 10.1093/gerona/glw004. Epub 2016 Feb 1.
- Barnish MS, Barnish J. High-heeled shoes and musculoskeletal injuries: a narrative systematic review. BMJ Open. 2016 Jan 13;6(1):e010053. doi: 10.1136/bmjopen-2015-010053.
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)
July 24, 2024
Primary Completion (Estimated)
April 5, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
March 15, 2024
First Submitted That Met QC Criteria
March 21, 2024
First Posted (Actual)
March 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Epidemiology of bunion
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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