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The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Project Osteoarthritis:Construction and Multidimensional Validation

The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Project Osteoarthritis:Construction and Multidimensional Validation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108660
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-09-14
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

KA Group:High tibial osteotomy (HTO) with a kinematic alignment target
Dynamic dual-mode alignment group:HTO with dynamic dual-mode alignment optimization combined with the intelligent precision knee-preserving system
Traditional alignment group:HTO with traditional Fujisawa alignment

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age between 40 and 70 years; 2.Unilateral medial compartment knee osteoarthritis (mild to moderate pain); 3.Mild to moderate varus deformity (5°–15°); 4.Coronal MRI showing medial meniscus extrusion (MME) >3 mm and flexion contracture <10°; 5.Intact lateral meniscus and articular cartilage; 6.Willingness to voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or systemic inflammatory diseases; 2.Patients with severe varus deformity (>10°) or flexion contracture >10°; 3.Patients with lateral meniscus pathology (tear, discoid meniscus) or knee joint instability; 4.Patients with a history of major knee trauma, infection, or prior knee surgery; 5.Patients with severe patellofemoral osteoarthritis; 6.Patients with advanced medial compartment osteoarthritis (bone-on-bone contact or knee subluxation); 7.Patients who refuse second-look arthroscopy or participation in the study; 8.Patients unable to complete at least 12 months of follow-up; 9.Patients with severe osteoporosis; 10.Patients with cognitive impairment.

Design outcomes

Primary

MeasureTime frame
KAM relative decline rate (%?KAM);—

Secondary

MeasureTime frame
HKA Accuracy;KOOS score;WOMAC score;Lysholm score;HSS score;MCID achievement rate;Operative time;Number of intraoperative fluoroscopies;Reoperation rate;—

Countries

China

Contacts

Public ContactZhang Lei

The First Affiliated Hospital of Wenzhou Medical University

zhanglei@wmu.edu.cn+86 135 8755 7573

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026