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NCT Number: NCT07284524

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325200, China

Location contact

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

CONTACT

[email protected]

13587557573

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

HTO procedure

Behavioral

HTO procedure for knee osteoarthritis

Primary outcomes

  1. Relative ΔKAM (%)

    Time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

    Relative ΔKAM (%) = [(KAM_follow-up - KAM_preoperative) / KAM_preoperative] × 100%

  2. HKA Accuracy

    Time frame: Preoperative, and 12 months postoperatively

    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.

  3. KOOS score

    Time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

    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).

  4. WOMAC Osteoarthritis Index

    Time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

    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).

  5. HSS score

    Time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

    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.

  6. Lysholm score

    Time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

    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.

Secondary outcomes

  1. MCID achievement rate

    Time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

    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.
  2. Operative time

    Time frame: Intraoperative

    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.

  3. Number of fluoroscopic shots

    Time frame: Intraoperative

    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.

  4. Reoperation rate

    Time frame: 12 months postoperatively

    The proportion of patients requiring reoperation within 12 months of follow-up due to mechanical failure, fracture, or implant-related issues

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+8613587557573

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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