National Taiwan University Hospital, Bei-Hu Branch
Taipei, Taipei City, 108, Taiwan
Location status: Recruiting
Location contact
Ke-Vin Chang, MD, PhD
CONTACT
Wei-Ting Wu, MD
CONTACT
NCT Number: NCT07744789
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.
Interested in participating?
Request Info20 year and older
All sexes
Observational
Taipei, Taipei City, 108, Taiwan
Location status: Recruiting
Ke-Vin Chang, MD, PhD
CONTACT
Wei-Ting Wu, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 ligament injection using corticosteroid, hypertonic dextrose, or platelet-rich plasma according to clinical indication.
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Contact information is provided by the study sponsor or research team.
Ke-Vin Chang, MD, PhD
CONTACT
Wei-Ting Wu, MD
CONTACT
National Taiwan University Hospital
Other
Across Ethnicities of Norm of Knee Ligament Stiffness and Its Association With Osteoarthritis Before/After Treat-ment: a Sonoelastography Model
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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