Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-05 @ 2:17 PM
Study NCT ID:
NCT04752995
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2021-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056305', 'term': 'Genu Varum'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010027', 'term': 'Osteotomy'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'prospective randomized study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proximal medial tibial angle', 'timeFrame': 'one year', 'description': 'This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction'}, {'measure': 'the posterior proximal tibial angle', 'timeFrame': 'one year', 'description': 'confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)'}, {'measure': 'Self-Administered Patient Satisfaction Scale', 'timeFrame': 'one year', 'description': 'the investigators asked the parents to rate their satisfaction on a scale from zero to 100 (100 to 75 very satisfied, \\<75 to 50 somewhat satisfied, \\<50 to 25 somewhat dissatisfied and \\<25 dissatisfied).Those who were not satisfied are requested to explain the cause of dissatisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genu varum, mini-invasive, osteotomy, osteoclasis'], 'conditions': ['Deformity Knee', 'Deformity of Limb']}, 'referencesModule': {'references': [{'pmid': '20234769', 'type': 'BACKGROUND', 'citation': 'Rab GT. Oblique tibial osteotomy revisited. J Child Orthop. 2010 Apr;4(2):169-72. doi: 10.1007/s11832-009-0228-z. Epub 2009 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'Genu-varum is a common problem encountered in pediatric orthopedic. Correction of pathological deformity is mandatory to ensure normal load transfer through the knee. In this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum', 'detailedDescription': 'Seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. Follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '52 Months', 'minimumAge': '36 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Infantile genu-varum\n* PMTA≤70 not spontaneously corrected\n\nExclusion criteria:\n\n* Active rickets or other metabolic disease\n* Patients in whom the femur or the joint is the main site of the deformity'}, 'identificationModule': {'nctId': 'NCT04752995', 'briefTitle': 'Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum: Improving the Technique and Managing Potential Complications.', 'orgStudyIdInfo': {'id': 'Tanta u'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'high tibial osteotomy', 'description': 'Under general anesthesia, a one-cm vertical skin incision was done at the medial subcutaneous border of the tibia, one fingerbreadth below the tibial tuberosity. This was confirmed by intra-operative C-arm images. Longitudinal periosteal incision was done with minimal dissection. Incomplete medial transverse osteotomy including both anterior and posterior cortex was performed using drill bit or small thin osteotome.Osteotomy was completed manually by osteoclasis of the lateral cortex to provide postoperative stability by the preserved lateral periosteum. No fibular osteotomy was needed in the present study.', 'interventionNames': ['Procedure: osteotomy']}], 'interventions': [{'name': 'osteotomy', 'type': 'PROCEDURE', 'description': 'osteotomy osteoclasis of upper tibia', 'armGroupLabels': ['high tibial osteotomy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the investigators will publish the final results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'ahmed m. samy', 'investigatorAffiliation': 'Tanta University'}}}}