Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 8:39 PM
Study NCT ID:
NCT07400705
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Outcomes of High Tibial Osteotomy Using a Plate Versus a Plate With an Interbody Fusion Cage in Adolescent Tibia Vara : a Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-03', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correction of tibia vara radiologically', 'timeFrame': '6 months', 'description': 'Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.'}, {'measure': 'correction of tibia vara on radiographs', 'timeFrame': '6 months', 'description': 'Change in MPTA from baseline to 6 months, measured on radiographs by two blinded observers.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg.'], 'conditions': ['Tibia Vara in Children']}, 'referencesModule': {'references': [{'pmid': '28072702', 'type': 'BACKGROUND', 'citation': 'Jang SH, Chang CH, Jung YJ, Kwon HG. Hypersomnia due to injury of the ventral ascending reticular activating system following cerebellar herniation: A case report. Medicine (Baltimore). 2017 Jan;96(1):e5678. doi: 10.1097/MD.0000000000005678.'}], 'seeAlsoLinks': [{'url': 'https://www.orthobullets.com/recon/3135/high-tibial-osteotomy', 'label': 'Anteromedial incision , osteotomy cut and open using laminar spreader then insert suitable size cage and apply plate'}]}, 'descriptionModule': {'briefSummary': 'Tibia vara is a progressive angular deformity of the lower limb centered at the proximal tibial physis, producing a characteristic bowing of the leg. The condition is believed to result from an abnormal distribution of biomechanical stresses combined with an underlying genetic predisposition. (1) Excessive mechanical loading on the medial portion of the proximal tibial growth plate leads to asymmetric physeal activity, ultimately causing a pathologic varus deformity of the tibia.(²)', 'detailedDescription': 'The adolescent tibia vara may affect one or both limbs and is typically identified during or shortly before the pubertal growth spurt. (1) It is more frequently reported among individuals of African descent and those with a body mass index (BMI) greater than 40. (2) The increased body weight in these patients accentuates compressive forces on the posteromedial aspect of the proximal tibial physis,(3) resulting in localized inhibition of growth according to the Heuter-Volkmann principle, and leading to progressive varus deformity.(4) In many cases, associated deformities may also be observed at the distal tibia or femur, presenting as either varus or valgus alignment abnormalities.(5) Given the mechanical and structural nature of this deformity, corrective high tibial osteotomy (HTO) remains the cornerstone of surgical management in adolescent tibia vara. Modern fixation methods particularly the use of plate fixation versus plate combined with interbody fusion cage are being explored to enhance alignment correction, stability, and long-term outcomes in this challenging age group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged \\[10-18\\] years diagnosed with tibia vara.\n* Symptomatic varus deformity centered at the proximal tibia requiring surgical correction.\n* Both sexes included\n* Open or transitional growth plates are suitable for HTO.\n\nExclusion Criteria:\n\n* Prior tibial realignment surgery on the same side.\n* Ages below 10 years or above 18 years\n* Active infection, progressive metabolic disorder (e.g., rickets) or skeletal dysplasia, neuromuscular disorder, or systemic inflammatory arthritis.\n* Complex deformities need external fixation as the first-line treatment.\n* Patients with chronic comorbidities.\n* Associated with fractures in the same limb'}, 'identificationModule': {'nctId': 'NCT07400705', 'briefTitle': 'Short-term Outcomes of High Tibial Osteotomy Using a Plate Versus a Plate With an Interbody Fusion Cage in Adolescent Tibia Vara : a Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Short-term Outcomes of High Tibial Osteotomy Using a Plate Versus a Plate With an Interbody Fusion Cage in Adolescent Tibia Vara : a Comparative Study', 'orgStudyIdInfo': {'id': 'Soh-Med-26-1-3MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Corrective HTO with plate fixation only.', 'interventionNames': ['Procedure: high tibial osteotomy using interbody fusion cage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Corrective HTO with plate fixation plus an interbody fusion cage.', 'interventionNames': ['Procedure: high tibial osteotomy using interbody fusion cage']}], 'interventions': [{'name': 'high tibial osteotomy using interbody fusion cage', 'type': 'PROCEDURE', 'description': 'correction of adolescent tibia vara with high tibial osteotomy using interbody fusion cage', 'armGroupLabels': ['Group A: Corrective HTO with plate fixation only.', 'Group B: Corrective HTO with plate fixation plus an interbody fusion cage.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag Univesity Hospitals', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': '6 months anf for 5 years', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data and related study documents (protocol, CRF, SAP) will be made available upon reasonable request. Data will be accessible starting 6 months after the main results publication and will remain available for at least 5 years. Access will be granted to qualified researchers after approval of a research proposal and completion of a data sharing agreement. Data will be stored in a secure, publicly accessible repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor in sohag orthopedic department', 'investigatorFullName': 'Atef Ahmed Hafez', 'investigatorAffiliation': 'Sohag University'}}}}