Intelligent Precision Knee Preservation System for Knee Osteoarthritis

NCT ID: NCT07284524

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Knee Osteoarthritis (Knee OA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MA group

HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting the mechanical (Fujisawa) alignment (MA).

Group Type: PLACEBO_COMPARATOR

HTO procedure

Intervention Type: BEHAVIORAL

HTO procedure for knee osteoarthritis

KA Group

HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting a kinematic alignment (KA) target

Group Type: EXPERIMENTAL

HTO procedure

Intervention Type: BEHAVIORAL

HTO procedure for knee osteoarthritis

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

Group Type: EXPERIMENTAL

HTO procedure

Intervention Type: BEHAVIORAL

HTO procedure for knee osteoarthritis

Interventions

HTO procedure

HTO procedure for knee osteoarthritis

Intervention Type: BEHAVIORAL

Eligibility 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;

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zhang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Department of Orthopaedic Surgery The First Affiliated Hospital of Wenzhou Medical University

Locations

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Central Contacts

Lei Zhang, M.D., Ph.D.

Role: CONTACT

zhanglei@wmu.edu.cn

+8613587557573

Facility Contacts

Lei Zhang, M.D., Ph.D.

Role: primary

zhanglei@wmu.edu.cn

13587557573

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

KY2025-307

Identifier Type: -

Identifier Source: org_study_id