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NCT Number: NCT07744789

Knee Ligament Stiffness Across Ethnicities Before and After Osteoarthritis Treatment

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shear Wave Elastography

Procedure

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 Therapy

Procedure

Ultrasound-guided ligament injection using corticosteroid, hypertonic dextrose, or platelet-rich plasma according to clinical indication.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain Intensity

    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.

  2. Physical Function

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ke-Vin Chang, MD, PhD

CONTACT

[email protected]

+886-2-23717101

Wei-Ting Wu, MD

CONTACT

[email protected]

+886-2-23717101

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Taiwan University Hospital Beihu Branch

Registry information

Official study title

Across Ethnicities of Norm of Knee Ligament Stiffness and Its Association With Osteoarthritis Before/After Treat-ment: a Sonoelastography Model

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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