Knee OsteoarthritisNCT07744789
Knee Ligament Stiffness Across Ethnicities Before and After Osteoarthritis Treatment
An observational study of Knee Osteoarthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This prospective clinical study aims to establish normative values of knee ligament stiffness across different ethnic populations using shear wave elastography (SWE) and to investigate biomechanical alterations associated with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Shear Wave Elastography and Ultrasound-Guided Injection Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 208 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jul 2023to 1 Dec 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers and adults with symptomatic radiographic knee osteoarthritis recruited from the outpatient Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital, Bei-Hu Branch. Healthy participants are enrolled to establish normative knee ligament stiffness values, whereas patients with knee osteoarthritis undergo clinical assessment, shear wave elastography, and, when clinically indicated, follow-up evaluation after ultrasound-guided injection therapy.
Who may be able to join
- Healthy volunteers:
- Adults aged 20 years or older.
- Able to understand the study procedures and provide written informed consent.
- Able to ambulate independently without walking aids.
- No pain in either knee during the previous 6 months.
- Patients with symptomatic knee osteoarthritis:
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- Adults aged 20 years or older.
- Able to understand the study procedures and provide written informed consent.
- Pain in at least one knee during the previous year.
- Knee pain, soreness, or stiffness documented within the previous month.
- Radiographic knee osteoarthritis defined by at least one of the following:
- Kellgren-Lawrence grade ≥2 on anteroposterior radiographs.
- Kellgren-Lawrence grade ≥2 on skyline radiographs.
- Superior or inferior patellar osteophytes or posterior tibial osteophytes on lateral radiographs.
Who cannot join
- Healthy volunteers:
- Previous knee surgery.
- Rupture of any cruciate or collateral ligament.
- Major knee or periarticular trauma.
- Rheumatic or autoimmune disease.
- Diagnosis of knee osteoarthritis within the previous 6 months.
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- Patients with symptomatic knee osteoarthritis:
- Rheumatic or autoimmune disease.
- Malignancy.
- Previous major knee trauma or knee surgery.
- Corticosteroid injection into the affected knee within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Bei-Hu Branch
Taipei, Taipei City, 108
Ke-Vin Chang, MD, PhD, +886-2-23717101, kvchang011@gmail.com
Wei-Ting Wu, MD, wwtaustin@yahoo.com.tw
About this study
Official title: Across Ethnicities of Norm of Knee Ligament Stiffness and Its Association With Osteoarthritis Before/After Treat-ment: a Sonoelastography Model
This prospective clinical study aims to establish normative values of knee ligament stiffness across different ethnic populations using shear wave elastography (SWE) and to investigate biomechanical alterations associated with knee osteoarthritis (OA). Healthy adults and patients with symptomatic knee OA will undergo standardized SWE examinations of the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL), together with clinical assessments. For patients who subsequently receive clinically indicated ultrasound-guided injection therapy, follow-up SWE and clinical evaluations will be performed to investigate changes in ligament stiffness after treatment.
Read the detailed description
Knee osteoarthritis is increasingly recognized as a whole-joint disease involving not only articular cartilage but also periarticular soft tissues, including the cruciate and collateral ligaments. Although ultrasound elastography has been widely applied to musculoskeletal tissues, normative biomechanical data for knee ligaments remain limited, and the influence of osteoarthritis on ligament stiffness has not been fully characterized.
The primary objective of this study is to establish normative shear wave elastography values for the ACL, PCL, MCL, and LCL across different age groups and ethnic populations and to determine their associations with demographic characteristics, body composition, and limb dominance. A secondary objective is to compare ligament stiffness between healthy individuals and patients with radiographic knee osteoarthritis. Participants will undergo standardized ultrasound examinations, SWE measurements, physical examinations, pain assessment using the Visual Analog Scale (VAS), and functional assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Patients with symptomatic knee osteoarthritis will initially receive conservative treatment according to routine clinical practice. Those who subsequently undergo clinically indicated ultrasound-guided injection therapy, including corticosteroid, hypertonic dextrose prolotherapy, or platelet-rich plasma (PRP), will receive repeat clinical and SWE evaluations after completion of treatment to investigate longitudinal changes in ligament biomechanical properties. The study will also assess measurement reliability through intra- and inter-rater analyses.
- Conditions
- Knee Osteoarthritis
- Being tested
- Shear Wave Elastography, Ultrasound-Guided Injection Therapy
- Keywords
- Knee Osteoarthritis, Shear Wave Elastography, Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Ultrasound
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave ElastographyProcedure or surgery
Bilateral shear wave elastography of the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament was performed to quantify ligament stiffness.
Ultrasound-Guided Injection TherapyProcedure or surgery
Ultrasound-guided ligament injection using corticosteroid, hypertonic dextrose, or platelet-rich plasma according to clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy adults without knee pain or major systemic disease undergoing standardized clinical assessment and bilateral knee ligament shear wave elastography. Receives: Procedure: Shear Wave Elastography | |
| Symptomatic Knee Osteoarthritis | Adults with symptomatic radiographic knee osteoarthritis undergoing baseline clinical assessment, physical examination, and bilateral knee ligament shear wave elastography. Receives: Procedure: Shear Wave Elastography | |
| Knee Osteoarthritis After Injection Therapy | Participants with symptomatic knee osteoarthritis who subsequently receive clinically indicated ultrasound-guided injection therapy and undergo follow-up clinical and shear wave elastography assessments after treatment. Receives: Procedure: Shear Wave Elastography; Procedure: Ultrasound-Guided Injection Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Ligament Stiffness Measured by Shear Wave Elastography
Shear wave velocity (m/s) of the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL) measured using standardized shear wave elastography.
Measured: Baseline
Secondary outcomes (2)
Pain Intensity
Pain intensity assessed using the Visual Analog Scale (VAS). The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Baseline
Physical Function
Physical function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC consists of 24 items evaluating pain, stiffness, and physical function. Each item is scored on a 0-10 visual analog scale, with higher scores indicating greater pain, stiffness, and functional impairment. The total WOMAC score ranges from 0 to 240, with higher scores indicating worse symptoms and poorer physical function.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start26 Jul 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Beihu Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744789
- Sponsor's protocol ID
- 202210063RIND
- Status last verified
- Mar 2026
- First submitted
- 27 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Across Ethnicities of Norm of Knee Ligament Stiffness and Its Association With Osteoarthritis Before/After Treat-ment: a Sonoelastography Model
- ClinicalTrials.gov ID
- NCT07744789
- Acronym / sponsor ID
- 202210063RIND
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Shear Wave Elastography, Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Beihu Branch
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Aug 2026 (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.
This prospective clinical study aims to establish normative values of knee ligament stiffness across different ethnic populations using shear wave elastography (SWE) and to investigate biomechanical alterations associated with knee osteoarthritis (OA). Healthy adults and patients with symptomatic knee OA will undergo standardized SWE examinations of the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL), together with clinical assessments. For patients who subsequently receive clinically indicated ultrasound-guided injection therapy, follow-up SWE and clinical evaluations will be performed to investigate changes in ligament stiffness after treatment.
Detailed description
Knee osteoarthritis is increasingly recognized as a whole-joint disease involving not only articular cartilage but also periarticular soft tissues, including the cruciate and collateral ligaments. Although ultrasound elastography has been widely applied to musculoskeletal tissues, normative biomechanical data for knee ligaments remain limited, and the influence of osteoarthritis on ligament stiffness has not been fully characterized.
The primary objective of this study is to establish normative shear wave elastography values for the ACL, PCL, MCL, and LCL across different age groups and ethnic populations and to determine their associations with demographic characteristics, body composition, and limb dominance. A secondary objective is to compare ligament stiffness between healthy individuals and patients with radiographic knee osteoarthritis. Participants will undergo standardized ultrasound examinations, SWE measurements, physical examinations, pain assessment using the Visual Analog Scale (VAS), and functional assessment using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Patients with symptomatic knee osteoarthritis will initially receive conservative treatment according to routine clinical practice. Those who subsequently undergo clinically indicated ultrasound-guided injection therapy, including corticosteroid, hypertonic dextrose prolotherapy, or platelet-rich plasma (PRP), will receive repeat clinical and SWE evaluations after completion of treatment to investigate longitudinal changes in ligament biomechanical properties. The study will also assess measurement reliability through intra- and inter-rater analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Procedure: Shear Wave ElastographyHealthy adults without knee pain or major systemic disease undergoing standardized clinical assessment and bilateral knee ligament shear wave elastography. |
| Symptomatic Knee Osteoarthritis | – | Procedure: Shear Wave ElastographyAdults with symptomatic radiographic knee osteoarthritis undergoing baseline clinical assessment, physical examination, and bilateral knee ligament shear wave elastography. |
| Knee Osteoarthritis After Injection Therapy | – | Procedure: Shear Wave Elastography, Procedure: Ultrasound-Guided Injection TherapyParticipants with symptomatic knee osteoarthritis who subsequently receive clinically indicated ultrasound-guided injection therapy and undergo follow-up clinical and shear wave elastography assessments after treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers and adults with symptomatic radiographic knee osteoarthritis recruited from the outpatient Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital, Bei-Hu Branch. Healthy participants are enrolled to establish normative knee ligament stiffness values, whereas patients with knee osteoarthritis undergo clinical assessment, shear wave elastography, and, when clinically indicated, follow-up evaluation after ultrasound-guided injection therapy.
Key inclusion criteria (14 listed)
- Healthy volunteers:
- Adults aged 20 years or older.
- Able to understand the study procedures and provide written informed consent.
- Able to ambulate independently without walking aids.
- No pain in either knee during the previous 6 months.
Key exclusion criteria (11 listed)
- Healthy volunteers:
- Previous knee surgery.
- Rupture of any cruciate or collateral ligament.
- Major knee or periarticular trauma.
- Rheumatic or autoimmune disease.
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 |
|---|---|---|
| Shear Wave ElastographyBilateral shear wave elastography of the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament was performed to quantify ligament stiffness. | Procedure or surgery | Healthy Controls, Knee Osteoarthritis After Injection Therapy, Symptomatic Knee Osteoarthritis |
| Ultrasound-Guided Injection TherapyUltrasound-guided ligament injection using corticosteroid, hypertonic dextrose, or platelet-rich plasma according to clinical indication. | Procedure or surgery | Knee Osteoarthritis After Injection Therapy |
Primary outcome
Knee Ligament Stiffness Measured by Shear Wave Elastography
Time frame: Baseline
Shear wave velocity (m/s) of the anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL) measured using standardized shear wave elastography.
2 secondary outcomes
Pain Intensity
Time frame: Baseline
Physical Function
Time frame: Baseline
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 6 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 14 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. 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 Taiwan. 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. 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 Ke-Vin Chang, MD, PhD (+886-2-23717101, kvchang011@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Ligament Stiffness Measured by Shear Wave Elastography (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.