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High-Tech knee surgery aims to beat arthritis pain

NCT ID NCT07284524

Disease control Sponsor: First Affiliated Hospital of Wenzhou Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This trial tests a new surgical system for knee osteoarthritis that uses 3D planning, custom guides, and augmented reality to improve alignment and reduce pain. About 150 people aged 40-70 with mild-to-moderate knee arthritis will be assigned to either the new system or traditional surgery. The goal is to see if the new approach leads to better knee function and fewer complications over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HTO procedure with 3D-printed guides and AR feedback
What this could lead to
If successful, this could lead to a more precise and effective surgical technique for knee osteoarthritis, potentially improving pain and function while reducing complications.
What could go wrong
This is an early-stage trial with only 150 participants, so results may not apply to everyone. The new system is complex and may not outperform standard surgery in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 40 and 70 years; 2. Unilateral medial compartment knee osteoarthritis (mild to moderate pain); 3. Mild to moderate varus deformity (5°-15°); 4. Coronal MRI showing medial meniscus extrusion (MME) \>3 mm and flexion contracture \<10°; 5. Intact lateral meniscus and articular cartilage; Exclusion Criteria: 1. Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or systemic inflammatory diseases; 2. Patients with severe varus deformity (\>10°) or flexion contracture \>10°; 3. Patients with lateral meniscus pathology (tear, discoid meniscus) or knee joint instability; 4. Patients with a history of major knee trauma, infection, or prior knee surgery; 5. Patients with severe patellofemoral osteoarthritis; 6. Patients with advanced medial compartment osteoarthritis (bone-on-bone contact or knee subluxation); 7. Patients who refuse second-look arthroscopy or participation in the study; 8. Patients unable to complete at least 12 months of follow-up; 9. Patients with severe osteoporosis; 10. Patients with cognitive impairment.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee osteoarthritis (knee oa)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325200, China

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