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NCT07721116

Overview

NCT ID: NCT07721116
Lead Sponsor: National Taiwan University HospitalOTHER
Official Title: Artificial Intelligence-Assisted Advanced Analysis of Knee Imaging and Outcome Prediction for Ultrasound-Guided Injections
Brief Summary: This study aims to develop and validate an artificial intelligence (AI)-assisted platform for musculoskeletal knee ultrasonography and to establish an interpretable prediction model for clinical outcomes following ultrasound-guided injection therapies in patients with degenerative knee disorders. The project seeks to improve the standardization, reproducibility, and clinical utility of knee ultrasound by reducing operator dependency and providing quantitative image analysis and outcome prediction.

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, including tendons, ligaments, cartilage, fat pads, and peripheral nerves. 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.

The anticipated outcome of this study is the development of a comprehensive AI-assisted knee ultrasound platform that supports standardized image interpretation, quantitative assessment of musculoskeletal pathology, and personalized prediction of treatment response to ultrasound-guided injection therapies in degenerative knee disorders.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jul 1, 2026Estimated
Primary Completion Date: Dec 31, 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 310Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Wei-Ting Wu, MDContact
wwtaustin@yahoo.com.tw+886223717101

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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