[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609299":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":48,"responsibleParty":68,"collaborators":71,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Malaga","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional surgery","ACTIVE_COMPARATOR","Osteotomy using conventional technique",[13],"Procedure: Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques",{"label":15,"type":16,"description":17,"interventionNames":18},"Patient-specific instrumentation","EXPERIMENTAL","Osteotomy using 3D-printed patient-specific instrumentation",[19],"Procedure: Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Medial Open Wedge Hight Tibial Osteotomy using patient-specific instrumentation","Medial Open Wedge Hight Tibial Osteotomy using 3D printed patient-specific instrumentation as a guide for the osteotomy",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Medial Open Wedge Hight Tibial Osteotomy using conventional surgery techniques","Conventional Medial Open Wedge Hight Tibial Osteotomy",[9],[32,36],{"name":33,"affiliation":34,"role":35},"Antonio I Cuesta-Vargas, Prof., PhD","Universidad de Málaga","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Juan Miguel Gómez-Palomo, PhD","Hospital Universitario Virgen de la Victoria",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Amparo Zamora-Mogollo","CONTACT","+34673662020","amparo.zamora@uma.es",{"name":46,"role":42,"phone":26,"phoneExt":26,"email":47},"Juan Miguel Gómez Palomo, PhD","jmgomezpalomo@gmail.com",[49],{"facility":50,"status":51,"city":52,"state":26,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hospital Universitario Virgen de la Victoria de Málaga","RECRUITING","Málaga","29010","Spain","ES",{"type":57,"coordinates":58},"Point",[59,60],-4.42034,36.72016,{"lat":60,"lon":59},[63,66],{"name":64,"role":42,"phone":65,"phoneExt":26,"email":47},"Juan Miguel Gómez-Palomo, Dr, PhD","+34647000340",{"name":67,"role":42,"phone":43,"phoneExt":26,"email":44},"Amparo Zamora-Mogollo, MSc",{"type":35,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr. Antonio I Cuesta-Vargas","Full Professor",[72],{"name":38,"class":6},"100609299","precision-of-pacient-specific-instrumented-open-wedge-high-tibial-osteotomy-vs-conventional-technicque-100609299",false,"NCT07212777","Precision of Pacient-specific Instrumented Open Wedge High Tibial Osteotomy vs Conventional Technicque","Precisión de la osteotomía Tibial Proximal Con Instrumental Paciente-específico vs técnica Convencional","AMBE_OR","Inclusion Criteria:\n\n* Informed consent: able to sign informed consent\n* Clinical: predominantly medial pain\u002Flimitation refractory ≥3-6 months\n* Mobility: flexion ≥90º and flexion contracture ≤10º Stability: varus\u002Fvalgus and pivot-shift ≤ grade 1.\n* Radiology:\n\n  * Medial gonarthrosis Ahlbäck I-III with preserved lateral compartment.\n  * Patellofemoral Iwano 0-2 without disabling patellofemoral pain.\n  * Varus alignment: HKA 4-10°.\n  * Predominantly tibial deformity (decreased MPTA; LDFA close to normal) according to planning.\n* Anatomy\u002Ftechnical feasibility: proximal tibial morphology suitable for medial opening osteotomy and PSI guide placement.\n\nExclusion criteria:\n\n* Comorbidity\u002Fclinical situations:\n\n  * Inflammatory arthritis (e.g., RA, spondyloarthropathies), unresolved previous joint infection or osteomyelitis.\n  * Severe peripheral vasculopathy (ABI \\\u003C0.7), advanced peripheral neuropathy or Charcot foot.\n  * Poorly controlled diabetes (HbA1c \\>8.5%), advanced renal\u002Fhepatic failure (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m²; Child-Pugh B\u002FC).\n  * Smoking \\>20 cigarettes\u002Fday without commitment to cessation; active IV drug use or uncontrolled alcoholism.\n  * BMI \\>35 kg\u002Fm².\n  * Disorder affecting gait (e.g., neurological disease).\n  * Inability to walk at a speed of at least 0.8m\u002Fs\n* Anatomy\u002Fradiology\n\n  * Multiplanar deformities not correctable with isolated medial opening tibial valgus osteotomy (e.g., dominant femoral deformity).\n  * Severe medial subchondral bone defect or extensive necrosis.\n  * Sequelae of proximal tibia fracture or previous ipsilateral HTO that prevent correction or guide use.\n* Treatments\u002Fmedication and logistics\n\n  * Anticoagulation\u002Fantiplatelet therapy that cannot be suspended or bridged.\n  * Systemic corticosteroids \\>10 mg\u002Fday or high-risk immunosuppressants without possibility of adjustment.\n  * Intra-articular infiltration (HA\u002FCS\u002FPRP) within the previous 60 days (respect defined wash-out).\n  * Pregnancy.\n  * Participation in another interfering trial.\n  * Inability to undergo CT (e.g., uncontrollable claustrophobia).\n  * Inability to complete ≥12 months of follow-up.","ALL","18 Years","70 Years",{"count":85,"type":86},50,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study is a randomized clinical trial that will compare two surgical techniques for patients with knee osteoarthritis and varus deformity who are candidates for medial opening wedge high tibial osteotomy. The goal is to evaluate whether using patient-specific 3D-printed surgical guides improves the accuracy of the bone cut compared with the conventional technique performed with anatomical landmarks and fluoroscopy.\n\nA total of 50 adult patients will be randomly assigned to one of two groups: conventional osteotomy or osteotomy assisted by patient-specific instrumentation (PSI). The main outcome is the accuracy of the osteotomy cut, measured by comparing preoperative planning with the postoperative CT scan. Secondary outcomes include leg alignment, surgical time, radiation exposure, complications, and functional recovery assessed with validated questionnaires (KOOS, WOMAC, IKDC, EQ-5D) and gait analysis using depth cameras.\n\nPatients will be followed for up to 12 months after surgery to evaluate clinical and radiological outcomes.",[92,93],"Arthritis (Knee)","Varus Knee",[95,96,97,98],"patient-specific instrumentation","knee osteotomy","Prospective","Randomised Controlled Trial","2026-04-02",{"date":101,"type":102},"2026-04-03","ACTUAL",{"date":104,"type":102},"2025-11-15",{"date":106,"type":86},"2028-10",{"name":5,"class":6},1]