Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-01 @ 2:30 PM
Study NCT ID:
NCT06335459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of Bunion and Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}, {'id': 'D000071378', 'term': 'Bunion'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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", 'timeFrame': 'baseline', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bunion', 'risk factors', 'epidemiology', 'upper egypt'], 'conditions': ['Hallux Valgus and Bunion']}, 'referencesModule': {'references': [{'pmid': '24559871', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33764800', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34268894', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26834078', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26769789', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Analysis of the collected data to determine:\n\n* Prevalence.\n* Risk factors. Radiological and clinical patterns and their association with specific risk factors Of Hallux Valgus', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged (18 - 80) including both sexes Males and Females\n* Patients with no Foot trauma or Neurological deficit\n\nExclusion Criteria:\n\n1. Post traumatic Hallux valgus\n2. post infection Hallux valgus\n3. Post Surgical Hallux valgus -'}, 'identificationModule': {'nctId': 'NCT06335459', 'briefTitle': 'Epidemiology of Bunion and Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Epidemiology and Risk Factors of Hallux Valgus in Upper Egypt', 'orgStudyIdInfo': {'id': 'Epidemiology of bunion'}}, 'armsInterventionsModule': {'interventions': [{'name': 'epidemiology', 'type': 'OTHER', 'description': 'Analysis of 2000 AP WB radiographs of Foot in Upper Egypt For Random People and determind cases of Hallux valgus and calculate the prevalence'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hosam Khaled, physion', 'role': 'CONTACT', 'email': 'Hossam.15235782@med.aun.edu.eg', 'phone': '01027931035'}, {'name': 'Amr aboelfadle, PhD', 'role': 'CONTACT', 'email': 'Amr.a.mohamed@aun.edu.eg', 'phone': '01007788699'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The epidemiology and risk factors of Hallux Valgus in upper Egypt', 'investigatorFullName': 'Hossam Khaled Mohamed Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}