Hallux Valgus and BunionNCT06335459
Epidemiology of Bunion and Risk Factors
An observational study of Hallux Valgus and Bunion, run by Assiut University.
Trial summary
Analysis of the collected data to determine: Prevalence. Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus and Bunion
- What is being tested?
- epidemiology
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2024to 1 Jun 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- aged (18 - 80) including both sexes Males and Females
- Patients with no Foot trauma or Neurological deficit
Who cannot join
- Post traumatic Hallux valgus
- post infection Hallux valgus
- Post Surgical Hallux valgus -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Conditions
- Hallux Valgus and Bunion
- Being tested
- epidemiology
- Keywords
- bunion, risk factors, epidemiology, upper egypt
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiologyOther
Analysis of 2000 AP WB radiographs of Foot in Upper Egypt For Random People and determind cases of Hallux valgus and calculate the prevalence
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start24 Jul 2024 (estimated)
- Primary completion5 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hallux Valgus and BunionStudies 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
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Khaled Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335459
- Sponsor's protocol ID
- Epidemiology of bunion
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24559871Steadman 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.
PubMed 33764800Menz 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.
PubMed 34268894Menz 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.
PubMed 26834078Barnish 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.
PubMed 26769789
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology and Risk Factors of Hallux Valgus in Upper Egypt
- ClinicalTrials.gov ID
- NCT06335459
- Acronym / sponsor ID
- Epidemiology of bunion
- Conditions
- Hallux Valgus and Bunion
- Keywords
- bunion, risk factors, epidemiology, upper egypt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 5 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 28 Mar 2024 (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.
Analysis of the collected data to determine:
- Prevalence.
- Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- aged (18 - 80) including both sexes Males and Females
- Patients with no Foot trauma or Neurological deficit
Key exclusion criteria (3 listed)
- Post traumatic Hallux valgus
- post infection Hallux valgus
- Post Surgical Hallux valgus -
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 |
|---|---|---|
| epidemiologyAnalysis of 2000 AP WB radiographs of Foot in Upper Egypt For Random People and determind cases of Hallux valgus and calculate the prevalence | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Background: PubMed 24559871Hecht 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.
- Background: PubMed 33764800Steadman 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.
- Background: PubMed 34268894Menz 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.
- Background: PubMed 26834078Menz 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.
- Background: PubMed 26769789Barnish 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.
Related trials for Hallux Valgus and Bunion
Active, not recruiting
LSTR in Chevron Osteotomy
Bunion
Not yet recruiting
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
Hallux Valgus and Bunion
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus and Bunion, run by Assiut University.
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 2 inclusion and 3 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 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Hosam Khaled, physion (01027931035, Hossam.15235782@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06335459, which also lists 5 linked publications.
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 28 Mar 2024.