Intelligent Precision Knee Preservation System for Knee Osteoarthritis

NCT07284524 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-307
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• MCID achievement rate

  Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

• Operative time

  Intraoperative

• Number of fluoroscopic shots

  Intraoperative

• Reoperation rate

  12 months postoperatively

Study Arms (3)

MA group

PLACEBO COMPARATOR

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

Behavioral: HTO procedure

KA Group

EXPERIMENTAL

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

Behavioral: HTO procedure

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

Behavioral: HTO procedure

Interventions

HTO procedure BEHAVIORAL

HTO procedure for knee osteoarthritis

DA group; KA Group; MA group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325200, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lei Zhang, M.D., Ph.D.

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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+8613587557573; zhanglei@wmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)