Knee Osteoarthritis (Knee OA)NCT07284524

Intelligent Precision Knee Preservation System for Knee Osteoarthritis

A study testing HTO procedure in people with Knee Osteoarthritis (Knee OA), run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Knee Osteoarthritis (Knee OA)
What is being tested?: HTO procedure
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 siteChina
Study dates: 1 Jan 2026to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

+8613587557573

zhanglei@wmu.edu.cn

China1 site

The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325200
Lei Zhang, M.D., Ph.D., 13587557573, zhanglei@wmu.edu.cn

Other trials in China

About this study

Official title: 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.

Conditions: Knee Osteoarthritis (Knee OA)
Being tested: HTO procedure
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HTO procedureBehavioural
HTO procedure for knee osteoarthritis

Study groups in NCT07284524
Study group	Role	What they receive
MA group	Placebo comparator	HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting the mechanical (Fujisawa) alignment (MA). Receives: Behavioral: HTO procedure
KA Group	Experimental	HTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting a kinematic alignment (KA) target Receives: 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 Receives: Behavioral: HTO procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative ΔKAM (%)
Relative ΔKAM (%) = [(KAM_follow-up - KAM_preoperative) / KAM_preoperative] × 100%
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: Intraoperative
Reoperation rate
The proportion of patients requiring reoperation within 12 months of follow-up due to mechanical failure, fracture, or implant-related issues
Measured: 12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202630 Jun 2027

First posted16 Dec 2025
Study start1 Jan 2026 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07284524
Sponsor's protocol ID: KY2025-307
Status last verified: Dec 2025
First submitted: 7 Sep 2025
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Interested in taking part?

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

+8613587557573

zhanglei@wmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Knee Osteoarthritis (Knee OA) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07284524
Acronym / sponsor ID: KY2025-307
Conditions: Knee Osteoarthritis (Knee OA)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
Study start: 1 Jan 2026 (estimated)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 16 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
MA group	Placebo comparator	Behavioral: HTO procedureHTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting the mechanical (Fujisawa) alignment (MA).
KA Group	Experimental	Behavioral: HTO procedureHTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting a kinematic alignment (KA) target
DA group	Experimental	Behavioral: HTO procedureHTO utilizing osteotomy-specific plates (e.g., TOMOFIX), targeting with dynamic dual-mode alignment (DA) optimization combined with the intelligent precision knee-preserving system

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HTO procedureHTO procedure for knee osteoarthritis	Behavioural	DA group, KA Group, MA group

Primary outcome

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%
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.
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).
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).
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.
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.

4 secondary outcomes

MCID achievement rate
Time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively
Operative time
Time frame: Intraoperative
Number of fluoroscopic shots
Time frame: Intraoperative
Reoperation rate
Time frame: 12 months postoperatively

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Individual participant dataSharing planned: No. 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.

Related trials for Knee Osteoarthritis (Knee OA)

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
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Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

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

+8613587557573

zhanglei@wmu.edu.cn

Lei Zhang, M.D., Ph.D. study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HTO procedure in people with Knee Osteoarthritis (Knee OA), run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Zhang, M.D., Ph.D. (+8613587557573, zhanglei@wmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative ΔKAM (%) (time frame: Preoperative, and 6 weeks, 3 months, 6 months, 12 months postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07284524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.