[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614817":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":57,"collaborators":29,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":29,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":29,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":29,"overallStatus":78,"whyStopped":29,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"MA group","PLACEBO_COMPARATOR","HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting the mechanical (Fujisawa) alignment (MA).",[13],"Behavioral: HTO procedure",{"label":15,"type":16,"description":17,"interventionNames":18},"KA Group","EXPERIMENTAL","HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting a kinematic alignment (KA) target",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"DA group","HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting with dynamic dual-mode alignment (DA) optimization combined with the intelligent precision knee-preserving system",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","HTO procedure","HTO procedure for knee osteoarthritis",[20,15,9],null,[31],{"name":32,"affiliation":33,"role":34},"Lei Zhang, M.D., Ph.D.","Department of Orthopaedic Surgery The First Affiliated Hospital of Wenzhou Medical University","STUDY_DIRECTOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},"CONTACT","+8613587557573","zhanglei@wmu.edu.cn",[41],{"facility":42,"status":29,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325200","China","CN",{"type":49,"coordinates":50},"Point",[51,52],120.66682,27.99942,{"lat":52,"lon":51},[55],{"name":32,"role":37,"phone":56,"phoneExt":29,"email":39},"13587557573",{"type":58,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100614817","intelligent-precision-knee-preservation-system-for-knee-osteoarthritis-100614817",false,"NCT07284524","Intelligent Precision Knee Preservation System for Knee Osteoarthritis","The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Osteoarthritis","Inclusion Criteria:\n\n1. Age between 40 and 70 years;\n2. Unilateral medial compartment knee osteoarthritis (mild to moderate pain);\n3. Mild to moderate varus deformity (5°-15°);\n4. Coronal MRI showing medial meniscus extrusion (MME) \\>3 mm and flexion contracture \\\u003C10°;\n5. Intact lateral meniscus and articular cartilage;\n\nExclusion Criteria:\n\n1. Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or systemic inflammatory diseases;\n2. Patients with severe varus deformity (\\>10°) or flexion contracture \\>10°;\n3. Patients with lateral meniscus pathology (tear, discoid meniscus) or knee joint instability;\n4. Patients with a history of major knee trauma, infection, or prior knee surgery;\n5. Patients with severe patellofemoral osteoarthritis;\n6. Patients with advanced medial compartment osteoarthritis (bone-on-bone contact or knee subluxation);\n7. Patients who refuse second-look arthroscopy or participation in the study;\n8. Patients unable to complete at least 12 months of follow-up;\n9. Patients with severe osteoporosis;\n10. Patients with cognitive impairment.","ALL","40 Years","70 Years",{"count":70,"type":71},150,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this clinical trial is to verify whether the \"dynamic dual-mode alignment optimization + intelligent precision knee-preserving system\" (integrating static\u002Fkinematic target alignment, CT-based preoperative three-dimensional \\[3D\\] planning, 3D-printed guide plates, and intraoperative augmented reality \\[AR\\] real-time feedback) achieves a greater relative reduction in peak knee adduction moment (KAM) at 12 months postoperatively, while maintaining or improving knee clinical function and without increasing perioperative or long-term complication rates, compared with traditional knee-preserving strategies. The target population is patients aged 40-70 years with knee osteoarthritis (KOA; Kellgren-Lawrence grade II-III) who require high tibial osteotomy (HTO) for unilateral medial-compartment disease with mild-to-moderate varus deformity and who meet the inclusion and exclusion criteria.\n\nThe main questions are:\n\n* Can the dynamic dual-mode alignment + intelligent precision system achieve a greater relative reduction in peak KAM at 12 months postoperatively than traditional knee-preserving strategies?\n* Can this system improve static alignment accuracy, dynamic load parameters (e.g., KAM impulse and varus thrust), and patient-reported outcome (PRO) scores without increasing complication rates?\n* Can 3D-printed patient-specific instrumentation (PSI) guide plates and real-time AR feedback reduce intraoperative radiation exposure and shorten operative time compared with traditional methods?\n\nResearchers will compare:\n\nKinematic alignment (KA), traditional mechanical alignment (MA), and dynamic dual-mode alignment (DA) to evaluate the relative performance of alignment strategies;\n\n3D-printed PSI-guided HTO versus traditional fluoroscopy-guided HTO to assess the efficacy of PSI; and\n\nAR-assisted intraoperative adjustment versus traditional fluoroscopy-based adjustment to evaluate the precision of AR navigation.\n\nParticipants will:\n\n* Complete preoperative assessments, including laboratory tests (complete blood count, biochemistry, coagulation), imaging (full-length, weight-bearing lower-limb radiographs; knee CT and\u002For MRI as indicated), 3D gait analysis (to measure KAM, KAM impulse, and varus thrust), and PRO assessments (KOOS, WOMAC, and Lysholm scores)\n* Receive assigned surgical interventions: the DA group will undergo HTO guided by dual-mode alignment plus 3D-printed PSI and intraoperative AR feedback; the MA and KA groups will undergo HTO based on traditional or kinematic alignment, respectively; the traditional HTO group will undergo surgery relying on intraoperative fluoroscopy and surgeon experience.\n* Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months postoperatively, including imaging to assess alignment accuracy and bone healing, gait analysis, PRO assessments, and complication monitoring.\n* Record medication use and rehabilitation compliance throughout the study period.",[77],"Knee Osteoarthritis (Knee OA)","NOT_YET_RECRUITING","2025-12-02",{"date":81,"type":82},"2025-12-16","ACTUAL",{"date":84,"type":71},"2026-01-01",{"date":86,"type":71},"2027-06-30",{"name":5,"class":6},1]