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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MA group | Placebo Comparator | HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting the mechanical (Fujisawa) alignment (MA). |
|
| KA Group | Experimental | HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting a kinematic alignment (KA) target |
|
| DA group | Experimental | HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting with dynamic dual-mode alignment (DA) optimization combined with the intelligent precision knee-preserving system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTO procedure | Behavioral | HTO procedure for knee osteoarthritis |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MCID achievement rate | Minimal Clinically Important Difference (MCID) achievement rate :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Zhang, M.D., Ph.D. | Contact | +8613587557573 | zhanglei@wmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, M.D., Ph.D. | Department of Orthopaedic Surgery The First Affiliated Hospital of Wenzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325200 | China |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2025 | Sep 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| 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 |
| D012216 |
| Rheumatic Diseases |