Across Ethnicities of Norm of Knee Ligament Stiffness and Its Association With Osteoarthritis Before/After Treat-ment: a Sonoelastography Model
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Knee Ligament Stiffness Measured by Shear Wave Elastography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Healthy Controls
Healthy adults without knee pain or major systemic disease undergoing standardized clinical assessment and bilateral knee ligament shear wave elastography.
干预措施: Shear Wave Elastography (Procedure)
Symptomatic Knee Osteoarthritis
Adults with symptomatic radiographic knee osteoarthritis undergoing baseline clinical assessment, physical examination, and bilateral knee ligament shear wave elastography.
干预措施: Shear Wave Elastography (Procedure)
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.
干预措施: Shear Wave Elastography (Procedure)
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.
干预措施: Ultrasound-Guided Injection Therapy (Procedure)
结局指标
主要结局
Knee Ligament Stiffness Measured by Shear Wave Elastography
时间窗: 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.
次要结局
- Pain Intensity(Baseline)
- Physical Function(Baseline)