Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT06320769
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Rotational Guided Growth in Management of Increased Femoral Anteversion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-03-19', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait', 'timeFrame': '12 months', 'description': 'Foot Progression Angle 5-10 degrees by clinical gait assesment'}], 'secondaryOutcomes': [{'measure': 'Limb length discrepancy', 'timeFrame': '12 months', 'description': 'Difference between length of both limbs through clinical measurement'}, {'measure': 'Angular Deformities', 'timeFrame': '12 months', 'description': 'CR radiographic measuement including angles such as MPTA, LDFA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotational Guided Growth', 'Torsional Deformities', 'Guided Growth', 'Rotational Deformities'], 'conditions': ['Increased Femoral Anteversion']}, 'descriptionModule': {'briefSummary': 'Efficacy of guided growth in coronal plane deformity correction and limb length discrepancy has been well-established. Recently, studies have explored the validity of guided growth in correction of rotational deformity through a modified method of application.\n\nThis concept has been validated in animal studies, biomechanical studies and two limited human case series through different methods.\n\nThis study evaluates the efficacy of rotational guided growth in management of increased femoral anteversion using three different constructs.', 'detailedDescription': 'The purpose of this study is:\n\n1. Evaluate the efficacy of different constructs in correcting increased femoral anteversion clinically and radiographically.\n2. Asses possible complications of this new concept including LLD, undesired coronal, sagittal plane deformity and stiffness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with increased femoral anteversion causing in-toeing with decreased agility.\n* Aged 8 years and above with at least two years of bone growth remaining.\n\nExclusion Criteria:\n\n* Any patient who underwent previous femoral osteotomy.\n* Any patient with sick physis (skeletal dysplasias, post traumatic / post infective physeal damage, active rickets).\n* Cerebral Palsy (CP) patients'}, 'identificationModule': {'nctId': 'NCT06320769', 'briefTitle': 'Role of Rotational Guided Growth in Management of Increased Femoral Anteversion', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Role of Rotational Guided Growth in Management of Increased Femoral Anteversion', 'orgStudyIdInfo': {'id': '24101994'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotational Guided Growth', 'description': 'o On a radiolucent operating table with the child supine, a torniquet is applied. The limb is prepped and draped.\n\noA Kirschner wire is inserted in midsagittal plane of the distal femoral physis from medial to lateral under fluoroscopic guidance.\n\nAfter the initial step, One of three Surgical techniques might be used according to surgeon preference and patient age:\n\n* Plate technique\n* Non-absorbable suture technique\n* Cerclage wire technique', 'interventionNames': ['Device: Plate Technique']}], 'interventions': [{'name': 'Plate Technique', 'type': 'DEVICE', 'otherNames': ['Non-absorbable Suture Technique', 'Cerclage Wire Technique'], 'description': 'Using Plates, non-absorbable sutures or cerclage wires to guide the distal femoral physis towards rotational growth to correct deformity', 'armGroupLabels': ['Rotational Guided Growth']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'El-Waily', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Tarek Hassan Abdelaziz, Professor', 'role': 'CONTACT', 'email': 'drtarekibrahim@gmail.com', 'phone': '+201222421760'}], 'facility': 'Faculty of Medicine, Ainshams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Mohamed Mohamed Abdelghany Badr, Msc', 'role': 'CONTACT', 'email': 'abaghany@gmail.com', 'phone': '+201060085397'}, {'name': 'Tarek Hassan Abdelaziz', 'role': 'CONTACT', 'phone': '+201222421760'}], 'overallOfficials': [{'name': 'Tarek Hassan Abdelaziz, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}