Knee Ligament Stiffness Across Ethnicities Before and After Osteoarthritis Treatment (NCT07744789) | Clinical Trial Compass
RecruitingNot Applicable
Knee Ligament Stiffness Across Ethnicities Before and After Osteoarthritis Treatment
Taiwan208 participantsStarted 2023-07-26
Plain-language 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). 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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:
* 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.
Exclusion Criteria
* 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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring knee ligament stiffness using something called shear wave elastography — can you explain what that procedure involves and whether it's uncomfortable or carries any risks for someone with knee osteoarthritis?
2The trial is looking at ligament stiffness across different ethnicities before and after osteoarthritis treatment — does my ethnic background or the specific type of treatment I'm already receiving, or planning to receive, affect whether this study would be relevant to discuss for me?
3Since this study is labeled 'Phase NA,' it seems to be an observational or measurement study rather than a drug or procedure trial — can you help me understand what I would actually be asked to do if I participated, and whether it would change or interfere with my current treatment plan in any way?
4The primary outcome is measuring ligament stiffness, not directly testing a new treatment — so what potential benefit, if any, might participation offer me personally, versus this being mainly useful for building research knowledge?
5Are there standard treatments for my knee osteoarthritis that we should be prioritizing right now, and would participating in this observational study fit alongside that care without causing any delays?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knee Ligament Stiffness Measured by Shear Wave Elastography