Knee Osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria (1) Part 1 1) Age 40–80 years 2) Diagnosed as Knee Osteoarthritis (KOA) based on clinical and imaging assessments, in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2024 Edition) 3) Patients with KOA of all disease stages with Kellgren–Lawrence (KL) grade 1–4 on X-ray 4) Good communication ability, understanding of the study procedures, and voluntary signing of written informed consent (2) Part 2 1) Meet all inclusion criteria of Part 1, and voluntarily receive intra-articular injection therapy (PRP or HA) 2) Limited to patients with early-to-moderate KOA with KL grade 2–3 on X-ray 3) Moderate to severe knee pain, with Visual Analogue Scale (VAS) score >=4
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria (1) Part 1 1) Secondary knee osteoarthritis (e.g., post-traumatic, post-infectious joint degeneration) 2) Complicated with other systemic inflammatory joint diseases such as rheumatoid arthritis and gout, or symptomatic osteoarthritis in other joints 3) History of intra-articular injection in the target knee within the past 6 months 4) Systemic glucocorticoid / immunosuppressive therapy within the past 3 months 5) Severe systemic diseases (e.g., severe cardiovascular diseases, hepatic and renal complications, malignant tumors) and active infectious diseases (2) Part 2 In addition to meeting all exclusion criteria of Part 1, patients with any of the following conditions will also be excluded: 1) Hematological diseases, thrombocytopenia, or coagulation dysfunction; receiving immunosuppressive therapy, anticoagulant therapy, or antiplatelet aggregation therapy 2) Other knee conditions besides osteoarthritis, such as knee joint infection, history of knee surgery, knee tuberculosis, etc. 3) Absolute or relative contraindications to magnetic resonance imaging (MRI) (e.g., metal implants such as cardiac pacemakers), unable to cooperate with T2 mapping scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score;12-item Short Form Health Survey (SF-12);MRI T2 mapping quantification, T2 values of medial/lateral femoral condyle and medial/lateral tibial plateau;Knee ROM;Peripheral blood plasma, knee synovial fluid supernatant. Inflammatory factors: IL-6, IL-8, TNF-a, MCP-1 Matrix degradation: MMP-3, MMP-13 Tissue remodeling/repair: YKL-40, HGF Metabolic factor: Lepti; | — |
Countries
China
Contacts
Zhongshan Hospital, Fudan University