AI reads knee ultrasounds to predict injection success

NCT ID NCT07721116

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Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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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 Results may not be published yet.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.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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

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First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study is developing an artificial intelligence platform to analyze knee ultrasound images and predict outcomes after ultrasound-guided injections for degenerative knee disorders like osteoarthritis. Researchers will first train the AI to identify normal and abnormal knee structures, then test whether it can forecast which patients experience meaningful pain relief and functional improvement. The goal is to make knee ultrasound interpretation more consistent and help guide treatment decisions.

What this could mean

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

Active substance
artificial intelligence-assisted analysis of knee ultrasound images
What this could lead to
If successful, this AI tool could help doctors predict which patients with knee arthritis will get the most benefit from ultrasound-guided injections, making treatment more personalized.
What could go wrong
This is an early-stage study focused on developing and testing the AI model, not a treatment trial. The AI may not perform well enough in real-world settings, and results may not apply to all patients.

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.

Participants

About 310 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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.

Who is studied

The study will be conducted in three phases. First, an AI foundation model for knee ultrasonography will be developed using standardized image acquisition protocols to enable automated localization, segmentation, and quantitative assessment of major anatomical structures. Second, supervised machine learning models will be trained to classify normal and pathological ultrasound findings, including common degenerative and inflammatory abnormalities affecting the knee. Third, retrospective and prospective clinical data from approximately 150 patients receiving ultrasound-guided injection therapies will be integrated to develop and validate a predictive model for treatment outcomes using imaging biomarkers and clinical variables. Treatment response will be evaluated using validated patient-reported outcome measures, and explainable AI methods will be applied to improve model interpretability.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Objective 1: Development of an AI-Based Normative Model for the Healthy Knee Inclusion Criteria: * Clinical diagnosis of healthy adult without major systemic disease * Age ≥18 years * Able to understand and follow study instructions * Ambulatory without walking aids * No pain in either knee for at least 6 months before enrollment Exclusion Criteria: * Previous knee surgery * Rupture of one or more cruciate ligaments * Knee injection within the preceding 6 months * Major trauma involving the knee or periarticular region * Rheumatic or autoimmune disease Objective 2: Development of an AI-Based Model for the Identification of Pathological Knee Structures Inclusion Criteria: * Clinical diagnosis of radiographic knee osteoarthritis * Age ≥18 years * Knee pain in at least one knee during the preceding year * Medical records confirming knee pain, soreness, or stiffness within 1 month before enrollment * Radiographic evidence of knee osteoarthritis, defined by at least one of the following: * Kellgren-Lawrence grade ≥2 on anteroposterior radiographs * Kellgren-Lawrence grade ≥2 on skyline (patellofemoral) radiographs * Superior or inferior patellar osteophytes or posterior tibial osteophytes on lateral radiographs Exclusion Criteria: * Systemic rheumatic disease (e.g., rheumatoid arthritis or ankylosing spondylitis) * Malignancy * Previous major knee trauma (including fracture) * Previous knee surgery * Intra-articular corticosteroid injection within the preceding 3 months Objective 3: Development of an AI-Assisted Predictive Model for Injection Treatment Outcomes Inclusion Criteria: * Clinical diagnosis of radiographic knee osteoarthritis requiring ultrasound-guided injection therapy * Age ≥18 years * Knee pain in at least one knee during the preceding year * Medical records confirming knee pain, soreness, or stiffness within 1 month before enrollment * Radiographic evidence of knee osteoarthritis, defined by at least one of the following: * Kellgren-Lawrence grade ≥2 on anteroposterior radiographs * Kellgren-Lawrence grade ≥2 on skyline (patellofemoral) radiographs * Superior or inferior patellar osteophytes or posterior tibial osteophytes on lateral radiographs * Willingness to undergo ultrasound-guided injection therapy and complete scheduled follow-up assessments Exclusion Criteria: * Systemic rheumatic disease (e.g., rheumatoid arthritis or ankylosing spondylitis) * Malignancy * Previous major knee trauma (including fracture) * Previous knee surgery * Intra-articular corticosteroid injection within the preceding 3 months

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The places running it

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

  2. The official record

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Contacts and locations

Locations

  • National Taiwan University Hospital Beihu Branch

    RECRUITING

    Taipei, Taiwan, 108206, Taiwan

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