Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-31 @ 2:26 PM
Study NCT ID:
NCT07220434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-23
First Post:
2025-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-10-22', 'studyFirstSubmitQcDate': '2025-10-22', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)', 'timeFrame': 'Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.', 'description': 'ssessment of the mechanical axis on full-length weight-bearing radiographs (Measured in degrees).'}, {'measure': 'Change in Functional Status (Oxford Knee Score - OKS)', 'timeFrame': 'Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.', 'description': 'Patient-reported functional score assessing pain and knee function.'}, {'measure': 'Change in Pain Intensity (Visual Analogue Scale - VAS)', 'timeFrame': 'Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative', 'description': 'Patient-reported pain score from 0 (no pain) to 10 (intolerable pain).'}], 'secondaryOutcomes': [{'measure': 'Change in Femoro-Tibial Angle (FTA)', 'timeFrame': 'Baseline (Preoperative) and 12 Months Postoperative.', 'description': 'Change in the anatomical axis measured in degrees.'}, {'measure': 'Change in Mechanical Axis Percentage (MA%)', 'timeFrame': 'Baseline (Preoperative) and 12 Months Postoperative.', 'description': 'Change in the position of the weight-bearing line on the tibial plateau.'}, {'measure': 'Change in Posterior Tibial Slope (PTE)', 'timeFrame': 'Baseline (Preoperative) and 12 Months Postoperative.', 'description': 'Change in the tibial slope measured in degrees.'}, {'measure': 'Change in Patellar Height (Insall-Salvati Index)', 'timeFrame': 'Baseline (Preoperative) and 12 Months Postoperative.', 'description': 'Change in patellar height measured by the Insall-Salvati ratio.'}, {'measure': 'Incidence of Complications', 'timeFrame': 'Up to 12 months postoperative.', 'description': 'Incidence of adverse events including pin tract infection (especially Group 2), superficial or deep infection, non-union/delayed union, lateral cortex fracture, hardware exposure, or knee stiffness.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Medial Compartment Osteoarthritis', 'Genu Varum', 'Varus Deformity', 'High Tibial Osteotomy']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy, accuracy, and functional outcomes of two different surgical stabilization techniques for medial opening wedge high tibial osteotomy (HTO) in patients with varus deformity and medial compartment osteoarthritis. Patients will be prospectively randomized into two groups: Group 1 (Plate Fixation) will receive acute (single-stage) correction and stabilization with a medial HTO locking plate. Group 2 (HTO External Fixator) will receive stabilization using a self-adjusting HTO external fixator, followed by gradual correction (hemicallotasis/distraction) starting 7 days post-operatively. The study will evaluate radiological correction, functional improvement (using the Oxford Knee Score), and complication rates over a 12-month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Varus malalignment associated with medial compartment degeneration/osteoarthritis.\n\nIndication for Medial Opening Wedge HTO. Aged 18 years or older. Willing to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Advanced-stage osteoarthritis (Indication for Total Knee Arthroplasty). Previous open knee surgery on the same extremity. Inability to comply with follow-up appointments. Significant comorbidities (e.g., uncontrolled diabetes, rheumatoid arthritis).'}, 'identificationModule': {'nctId': 'NCT07220434', 'briefTitle': 'TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Medial Opening Wedge High Tibial Osteotomy: A Comparative Study of Plate Fixation and Self-Adjusting HTO External Fixator Techniques', 'orgStudyIdInfo': {'id': 'HTOexfix1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Plate Fixation', 'description': 'The osteotomy will be acutely corrected intraoperatively and stabilized using a Medial High Tibial locking plate.', 'interventionNames': ['Device: Medial HTO Locking Plate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: HTO External Fixator', 'description': 'he osteotomy will be stabilized using a Self-Adjusting HTO External Fixator. Gradual distraction (hemicallotasis) will begin 7 days post-operatively at a rate of 1 mm per day to achieve correction.', 'interventionNames': ['Device: Self-Adjusting HTO External Fixator']}], 'interventions': [{'name': 'Medial HTO Locking Plate', 'type': 'DEVICE', 'description': 'Medial Opening Wedge High Tibial Osteotomy.', 'armGroupLabels': ['Group 1: Plate Fixation']}, {'name': 'Self-Adjusting HTO External Fixator', 'type': 'DEVICE', 'description': 'Medial Opening Wedge High Tibial Osteotomy.', 'armGroupLabels': ['Group 2: HTO External Fixator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'state': 'Erzurum', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muhammed Çağatay ENGİN, Assoc. Prof.', 'role': 'CONTACT', 'email': 'mcagatayengin@hotmail.com', 'phone': '+90 532 330 1949'}], 'facility': 'Ataturk University, Department of Orthopedics and Traumatology', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'ali afşar, md', 'role': 'CONTACT', 'email': 'afsarali1708@gmail.com', 'phone': '+905374927543'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammed Cagatay Engin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Muhammed Cagatay Engin', 'investigatorAffiliation': 'Ataturk University'}}}}