[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609888":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":26,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Ataturk University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Plate Fixation","EXPERIMENTAL","The osteotomy will be acutely corrected intraoperatively and stabilized using a Medial High Tibial locking plate.",[13],"Device: Medial HTO Locking Plate",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: HTO External Fixator","ACTIVE_COMPARATOR","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.",[19],"Device: Self-Adjusting HTO External Fixator",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Medial HTO Locking Plate","Medial Opening Wedge High Tibial Osteotomy.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Self-Adjusting HTO External Fixator",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"ali afşar, md","CONTACT","+905374927543","afsarali1708@gmail.com",[37],{"facility":38,"status":26,"city":39,"state":39,"zip":40,"country":41,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Ataturk University, Department of Orthopedics and Traumatology","Erzurum","25240","Turkey (Türkiye)",{"type":43,"coordinates":44},"Point",[45,46],41.27694,39.90861,{"lat":46,"lon":45},[49],{"name":50,"role":33,"phone":51,"phoneExt":26,"email":52},"Muhammed Çağatay ENGİN, Assoc. Prof.","+90 532 330 1949","mcagatayengin@hotmail.com",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Muhammed Cagatay Engin","Associate Professor","100609888","to-plate-fixation-vs-external-fixator-comparison-hto-plate-vs-exfix-study-100609888",false,"NCT07220434","TO Plate Fixation vs. External Fixator Comparison (HTO Plate vs. ExFix Study)","Medial Opening Wedge High Tibial Osteotomy: A Comparative Study of Plate Fixation and Self-Adjusting HTO External Fixator Techniques","Inclusion Criteria:\n\n* Varus malalignment associated with medial compartment degeneration\u002Fosteoarthritis.\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).","ALL","18 Years",{"count":67,"type":68},28,"ESTIMATED","INTERVENTIONAL",[71],"NA","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\u002Fdistraction) 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.",[74,75,76,77],"Medial Compartment Osteoarthritis","Genu Varum","Varus Deformity","High Tibial Osteotomy","NOT_YET_RECRUITING","2025-10-22",{"date":81,"type":82},"2025-10-23","ACTUAL",{"date":84,"type":68},"2025-11-15",{"date":86,"type":68},"2028-12-31",{"name":55,"class":6},1]