Intelligent Precision Knee Preservation System for Knee Osteoarthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis (Knee OA)
• Intervention / Treatment: Behavioral: HTO procedure

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Zhang, M.D., Ph.D.; Phone Number: +8613587557573; Email: zhanglei@wmu.edu.cn

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325200
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Lei Zhang, M.D., Ph.D.; Phone Number: 13587557573; Email: zhanglei@wmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: MA group; HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting the mechanical (Fujisawa) alignment (MA).	Behavioral: HTO procedure; HTO procedure for knee osteoarthritis
Experimental: KA Group; HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting a kinematic alignment (KA) target	Behavioral: HTO procedure; HTO procedure for knee osteoarthritis
Experimental: 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	Behavioral: HTO procedure; HTO procedure for knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative ΔKAM (%)	Relative ΔKAM (%) = [(KAM_follow-up - KAM_preoperative) / KAM_preoperative] × 100%	Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively
HKA Accuracy	HKA accuracy is defined as the proportion of operated knees whose hip-knee-ankle (HKA) angle falls within the prespecified target window (±2°) on full-length, weight-bearing radiographs at 12 months postoperatively.	Preoperative, and 12 months postoperatively
KOOS score	Knee Injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire (paper or electronic; 1-week recall) with 42 items across five subscales: Symptoms, Pain, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec), and Knee-related Quality of Life (QOL). Items are rated 0-4. For each subscale, raw scores are summed and transformed to a 0-100 scale using: Score = 100 - [(sum of item scores × 100) ÷ (4 × number of items)]. Minimum = 0 (worst outcome); Maximum = 100 (best outcome); higher scores indicate better status. Subscales are reported separately. If reported, "KOOS4" is the mean of Pain, Symptoms, Sport/Rec, and QOL, also on a 0-100 scale with 0 = worst and 100 = best (higher = better).	Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively
WOMAC Osteoarthritis Index	The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index is a self-administered questionnaire designed to assess pain, stiffness, and physical function in patients with hip and knee osteoarthritis. It contains 24 items across three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each item is scored on a Likert scale (0-4; none to extreme) or sometimes a 100-mm visual analogue scale, depending on the version used. Scores are summed for each subscale and can be normalized to a 0-100 scale (higher scores indicate worse symptoms).	Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively
HSS score	The Hospital for Special Surgery (HSS) score is a clinician-administered questionnaire designed to evaluate knee function. It includes six domains: pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), flexion deformity (10 points), and instability (10 points), with deductions for the use of walking aids. The maximum score is 100 points, with higher scores indicating better knee function: >85 excellent, 70-84 good, 60-69 fair, and <60 poor.	Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively
Lysholm score	The Lysholm score is a patient-reported outcome measure originally designed for knee ligament injuries, widely used to evaluate knee symptoms and function. It consists of 8 items: limp, need for support, locking, instability, pain, swelling, stair climbing, and squatting. Each item is assigned a weighted point value, and the total score ranges from 0 to 100, with higher scores indicating better knee function. Scores are commonly interpreted as: 95-100 excellent, 84-94 good, 65-83 fair, and <65 poor.	Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MCID achievement rate	Minimal Clinically Important Difference (MCID) achievement rate : For the target outcome, compute each participant's change from baseline to follow-up, signed so that improvement is positive (e.g., Δᵢ = Follow-up - Baseline for "higher=better"; Δᵢ = Baseline - Follow-up for "higher=worse").; Mark a responder if Δᵢ ≥ MCID (or if using percent MCID: Δ%ᵢ = Δᵢ / Baseline × 100 ≥ MCID%).; MCID achievement rate (%) = (number of responders ÷ number analyzed at that time point) × 100.	Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively
Operative time	Operative time is calculated as the interval from the first skin incision to completion of skin closure, recorded in minutes from the operating-room record.	Intraoperative
Number of fluoroscopic shots	The total count of discrete single-image X-ray exposures acquired on the patient from first skin incision to completion of skin closure, as recorded by the C-arm exposure log/PACS.	Intraoperative
Reoperation rate	The proportion of patients requiring reoperation within 12 months of follow-up due to mechanical failure, fracture, or implant-related issues	12 months postoperatively

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wenzhou Medical University
• Investigators: Study Director: Lei Zhang, M.D., Ph.D., Department of Orthopaedic Surgery The First Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 7, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KY2025-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing is planned due to the high re-identification risk from radiographs/CT/MRI and 3D gait waveforms under our institution's privacy policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No