Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-19 @ 1:15 PM
Study NCT ID:
NCT06812195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periprosthetic Plate Over Humeral Nail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Under spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of humeral nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft. Weight bearing is allowed after confirmation of union after 6 weeks. Regular visits every 3 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-08', 'studyFirstSubmitDate': '2025-02-01', 'studyFirstSubmitQcDate': '2025-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metal failure', 'timeFrame': '2 years', 'description': 'Number of cases with bending or protrusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deformity', 'osteoporosis'], 'conditions': ['Osteopenia, Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '15289686', 'type': 'BACKGROUND', 'citation': 'Gordon JE, Khanna N, Luhmann SJ, Dobbs MB, Ortman MR, Schoenecker PL. Intramedullary nailing of femoral fractures in children through the lateral aspect of the greater trochanter using a modified rigid humeral intramedullary nail: preliminary results of a new technique in 15 children. J Orthop Trauma. 2004 Aug;18(7):416-22; discussion 423-4. doi: 10.1097/00005131-200408000-00004.'}]}, 'descriptionModule': {'briefSummary': 'use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone', 'detailedDescription': 'small IM interlocking nail, such as humeral nail, could be used in femoral fixation in normal adolescent patients due to the advantages of the entry point lateral to tip of greater trochanter resulting in avoiding iatrogenic vascular injury and being the IM locking device with smaller diameter and shorter length than conventional femoral nail which was appropriate for small-sized adolescent femoral anatom'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoporotic bone with femoral deformity.\n* Osteogenesis imperfecta. --Vitamin D deficiency ricket\n\nExclusion Criteria:\n\n* Uncooperative patient.\n\n \\-- Skeletally immature\n* Not receiving medical treatment.\n* Patient with history of allergy to drugs used in the study.\n* Neuromuscular pathology, previous trauma, or surgery to the leg'}, 'identificationModule': {'nctId': 'NCT06812195', 'acronym': 'osteoporosis', 'briefTitle': 'Periprosthetic Plate Over Humeral Nail', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Plate Over Humeral Nail in Deformity Correction of Femur in Adult Osteoporotic Bone', 'orgStudyIdInfo': {'id': 'PPON'}, 'secondaryIdInfos': [{'id': 'PPOND', 'type': 'OTHER', 'domain': 'Faculty of Medicine for Girls Al-Azhar University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'plate over humeral nail', 'description': 'spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft', 'interventionNames': ['Device: Plate and nail']}], 'interventions': [{'name': 'Plate and nail', 'type': 'DEVICE', 'description': 'spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of nail according to preoperative plan. After that, plate is applied to lateral border to the femoral shaft', 'armGroupLabels': ['plate over humeral nail']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hesham m Elbaseet, MD', 'role': 'CONTACT', 'email': 'drhesham20@aun.edu.eg', 'phone': '201007780689', 'phoneExt': '20'}], 'overallOfficials': [{'name': 'Hesham M Elbaseet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of orthopedics', 'investigatorFullName': 'Hesham Mohamed Elbaseet', 'investigatorAffiliation': 'Assiut University'}}}}