Knee Ligament Stiffness Across Ethnicities Before and After Osteoarthritis Treatment

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Shear Wave Elastography
  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.
• Процедура Ultrasound-Guided Injection Therapy
  Ultrasound-guided ligament injection using corticosteroid, hypertonic dextrose, or platelet-rich plasma according to clinical indication.

Первичные конечные точки

• Knee Ligament Stiffness Measured by Shear Wave Elastography [Срок оценки: Baseline]

Вторичные конечные точки (2)

• Pain Intensity [Срок оценки: Baseline]
• Physical Function [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital, Bei-Hu Branch — Taipei

Идентификаторы

NCT: NCT07744789 · 202210063RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗