Intelligent Precision Knee Preservation System for Knee Osteoarthritis
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
Source: NCT07284524, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- First Affiliated Hospital of Wenzhou Medical University
- Trial code
- NCT07284524
- Record updated
- 16 December 2025
- Original description
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.Read full original descriptionShow less
The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Osteoarthritis
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.
Inclusion: 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.
Exclusion: Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or systemic inflammatory diseases; Patients with a history of major knee trauma, infection, or prior knee surgery; Patients with cognitive impairment; Patients with severe varus deformity (>10°) or flexion contracture >10°; Patients with lateral meniscus pathology (tear, discoid meniscus) or knee joint instability; 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.