Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-29 @ 11:10 AM
Study NCT ID:
NCT05603858
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2022-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
End Button Tenodesis in Failed Developmental Dysplasia of the Hip Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-29', 'studyFirstSubmitDate': '2022-10-29', 'studyFirstSubmitQcDate': '2022-10-29', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Harris Hip Score', 'timeFrame': '6 months', 'description': 'score for function of the hip'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder']}, 'referencesModule': {'references': [{'pmid': '32730146', 'type': 'BACKGROUND', 'citation': 'Zhang S, Doudoulakis KJ, Khurwal A, Sarraf KM. Developmental dysplasia of the hip. Br J Hosp Med (Lond). 2020 Jul 2;81(7):1-8. doi: 10.12968/hmed.2020.0223. Epub 2020 Jul 6.'}, {'pmid': '29716513', 'type': 'BACKGROUND', 'citation': 'Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018 May 7;208(8):359-364. doi: 10.5694/mja18.00154.'}]}, 'descriptionModule': {'briefSummary': 'Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia \\& dislocation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients will be examined for:\n\nLength of both lower limbs in relation to each other. Length of both lower limbs according to patient age. Presence of hump related to the outer surface of the hip Presence of pain, abnormal gait, Trendlenburg test Radiographic evaluation (antero posterior and frog pelvis views)\n\nAn addition to the steps of the open reduction, the following were done:\n\n1. Trans articular suturing\n2. End button tenodesis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patient with Developmental dysplasia of the hip (DDH) with :\n\n* Age: up to 9 years old.\n* Recurrent DDH .\n* Failed open reduction through medial approach in the management of DDH.\n* Traumatic hip dislocation .\n\nExclusion Criteria:\n\n* • Paralytic hip dislocation .\n\n * Post septic hip dislocation.\n * Refusal to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05603858', 'briefTitle': 'End Button Tenodesis in Failed Developmental Dysplasia of the Hip Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'The Role of End Button Tenodesis in the Management of Failed Developmental Dysplasia of the Hip Surgery', 'orgStudyIdInfo': {'id': 'EBT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tenodesis by end button', 'description': 'open reduction of the dislocated hip and stabilization by end button', 'interventionNames': ['Procedure: Tenodesis by end button']}], 'interventions': [{'name': 'Tenodesis by end button', 'type': 'PROCEDURE', 'description': 'open reduction of the dislocated hip and stabilization by end button', 'armGroupLabels': ['Tenodesis by end button']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ahmed khashaba, MD', 'role': 'CONTACT', 'phone': '01023233949'}, {'name': 'Ibrahim AbuOmira', 'role': 'CONTACT', 'email': 'ibrahimabuomira@gmail.com', 'phone': '0201111266845'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Obeid Abd Allah', 'investigatorAffiliation': 'Al-Azhar University'}}}}