Knee Ligament Stiffness Across Ethnicities Before and After Osteoarthritis Treatment
Across Ethnicities of Norm of Knee Ligament Stiffness and Its Association With Osteoarthritis Before/After Treat-ment: a Sonoelastography Model
1 other identifier
observational
208
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2023
CompletedFirst Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
August 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 4, 2026
March 1, 2026
3.9 years
July 27, 2026
August 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee Ligament Stiffness Measured by Shear Wave Elastography
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.
Baseline
Secondary Outcomes (2)
Pain Intensity
Baseline
Physical Function
Baseline
Study Arms (3)
Healthy Controls
Healthy adults without knee pain or major systemic disease undergoing standardized clinical assessment and bilateral knee ligament shear wave elastography.
Symptomatic Knee Osteoarthritis
Adults with symptomatic radiographic knee osteoarthritis undergoing baseline clinical assessment, physical examination, and bilateral knee ligament shear wave elastography.
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.
Interventions
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.
Eligibility Criteria
Healthy adult volunteers and adults with symptomatic radiographic knee osteoarthritis recruited from the outpatient Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital, Bei-Hu Branch. Healthy participants are enrolled to establish normative knee ligament stiffness values, whereas patients with knee osteoarthritis undergo clinical assessment, shear wave elastography, and, when clinically indicated, follow-up evaluation after ultrasound-guided injection therapy.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital, Bei-Hu Branch
Taipei, Taipei City, 108, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2026
First Posted
August 4, 2026
Study Start
July 26, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
August 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share