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.
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°;
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;
Parallel
HTO procedure
BehavioralHTO procedure for knee osteoarthritis
Relative ΔKAM (%)
Relative ΔKAM (%) = \[(KAM\_follow-up - KAM\_preoperative) / KAM\_preoperative\] × 100%
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.
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).
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).
MCID achievement rate
Minimal Clinically Important Difference (MCID) achievement rate : 1. 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"). 2. Mark a responder if Δᵢ ≥ MCID (or if using percent MCID: Δ%ᵢ = Δᵢ / Baseline × 100 ≥ MCID%). 3. MCID achievement rate (%) = (number of responders ÷ number analyzed at that time point) × 100.
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.
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.
Reoperation rate
The proportion of patients requiring reoperation within 12 months of follow-up due to mechanical failure, fracture, or implant-related issues
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