Intelligent Precision Knee Preservation System for Knee Osteoarthritis

Официальное название

The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Osteoarthritis

Обзор

The goal of this clinical trial is to verify whether the "dynamic dual-mode alignment optimization + intelligent precision knee-preserving system" (integrating static/kinematic 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. The main questions are: * 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? * 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? * 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? Researchers will compare: Kinematic alignment (KA), traditional mechanical alignment (MA), and dynamic dual-mode alignment (DA) to evaluate the relative performance of alignment strategies; 3D-printed PSI-guided HTO versus traditional fluoroscopy-guided HTO to assess the efficacy of PSI; and AR-assisted intraoperative adjustment versus traditional fluoroscopy-based adjustment to evaluate the precision of AR navigation. Participants will: * Complete preoperative assessments, including laboratory tests (complete blood count, biochemistry, coagulation), imaging (full-length, weight-bearing lower-limb radiographs; knee CT and/or MRI as indicated), 3D gait analysis (to measure KAM, KAM impulse, and varus thrust), and PRO assessments (KOOS, WOMAC, and Lysholm scores) * 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. * 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. * Record medication use and rehabilitation compliance throughout the study period.

Вмешательства

• Поведенческое HTO procedure
  HTO procedure for knee osteoarthritis

Первичные конечные точки

• Relative ΔKAM (%) [Срок оценки: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively]
• HKA Accuracy [Срок оценки: Preoperative, and 12 months postoperatively]
• KOOS score [Срок оценки: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively]
• WOMAC Osteoarthritis Index [Срок оценки: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively]
• HSS score [Срок оценки: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively]
• Lysholm score [Срок оценки: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively]

Вторичные конечные точки (4)

• MCID achievement rate [Срок оценки: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively]
• Operative time [Срок оценки: Intraoperative]
• Number of fluoroscopic shots [Срок оценки: Intraoperative]
• Reoperation rate [Срок оценки: 12 months postoperatively]

Критерии участия

Критерии включения

• Age between 40 and 70 years;
• Unilateral medial compartment knee osteoarthritis (mild to moderate pain);
• Mild to moderate varus deformity (5°-15°);
• Coronal MRI showing medial meniscus extrusion (MME) >3 mm and flexion contracture <10°;
• Intact lateral meniscus and articular cartilage;

Критерии исключения

• Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or systemic inflammatory diseases;
• Patients with severe varus deformity (>10°) or flexion contracture >10°;
• Patients with lateral meniscus pathology (tear, discoid meniscus) or knee joint instability;
• Patients with a history of major knee trauma, infection, or prior knee surgery;
• Patients with severe patellofemoral osteoarthritis;
• Patients with advanced medial compartment osteoarthritis (bone-on-bone contact or knee subluxation);
• Patients who refuse second-look arthroscopy or participation in the study;
• Patients unable to complete at least 12 months of follow-up;
• Patients with severe osteoporosis;
• Patients with cognitive impairment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Идентификаторы

NCT: NCT07284524 · KY2025-307

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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