Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-09 @ 4:08 PM
Study NCT ID:
NCT05432505
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2022-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ligamentum Teres Tenodesis in Developmental Dysplasia of the Hip
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2022-06-21', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified HHS', 'timeFrame': '6 months', 'description': 'score for function of the hip'}]}, 'oversightModule': {'oversightHasDmc': False, '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': 'The treatment of developmental dysplasia of the hip (DDH) remains challenging, yet recent advances have refined our understanding of how best to survey for the condition during infancy, minimize complications during early treatment, and refine the selection of patients who can best benefit from hip preservation surgery. The ideal continued target would be to prevent missed hip dislocations or dysplasia during the infant period, prevent avascular necrosis (AVN) during early treatment, and decrease the incidence of total hip arthroplasty in adulthood related to undertreated DDH, The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.', 'detailedDescription': 'it is an operative technique to secure the femoral head after reduction in cases of developmental dysplasia of the hip\n\nOperative technique:\n\nThe surgery will be accomplished under a general anesthesia.\n\nAn addition to the steps of the open reduction, the following were done:\n\n1. Identification of ligamentum teres\n2. ligamentum teres tenodesis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '9 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients will be examined for:\n\n1. Length of both lower limbs in relation to each other.\n2. Length of both lower limbs according to patient age.\n3. Presence of hump related to the outer surface of the hip\n4. 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. Identification of ligamentum teres\n2. ligamentum teres tenodesis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Developmental dysplasia of the hip (DDH) with :\n\n * Age: from 9 months -5 years old.\n * Virgin DDH.\n * Failed closed reduction in the management of DDH.\n * Failed open reduction through medial approach in the management of DDH\n\nExclusion Criteria:\n\n* • Paralytic hip dislocation .\n\n * Post septic hip dislocation.\n * Traumatic hip dislocation .\n * Age : below 9 months or above 5 years.\n * Refusal to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05432505', 'briefTitle': 'Ligamentum Teres Tenodesis in Developmental Dysplasia of the Hip', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'The Role of Ligamentum Teres Tenodesis in the Management of Developmental Dysplasia of the Hip', 'orgStudyIdInfo': {'id': 'LTT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ligamentum teres tenodesis', 'type': 'OTHER', 'description': 'Identification of ligamentum teres ligamentum teres tenodesis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Obeid Abd Allah', 'investigatorAffiliation': 'Al-Azhar University'}}}}