RecruitingNot ApplicableNCT06932614

Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA

Comparing the Efficacy of Lyophilized Self Growth Factor Versus Platelet-Rich Plasma(PRP) Injection for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Controlled Trial

Sponsor

Tri-Service General Hospital

Enrollment

90 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis PRP Injection

Summary

Knee osteoarthritis(OA) is a common degenerative joint disease that often leads to knee pain, stiffness, and a decline in quality of life among middle-aged and elderly individuals. Platelet-rich plasma (PRP) is a regenerative treatment method that involves drawing a small amount of the patient's own blood and using centrifugation process to produce PRP. PRP, which is rich in growth factors and anti-inflammatory cytokines, facilitate the repair of damaged tissues and has been used in treating knee OA. Self-repair factor (SRF), an advanced form of PRP, is created using multi-step centrifugation and proprietary processes to increase platelet concentration. This enhancement may offer superior repair efficacy and faster recovery compared to traditional PRP. To explore this potential, we designed a randomized, double-blind, clinical trial to compare the effectiveness of SRF and PRP in treating degenerative knee osteoarthritis.

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria5

Male or female, aged over 20 and under 80.
Consciousness clear and able to communicate.
Unilateral or bilateral osteoarthritis of the knee with symptoms lasting more than 3 months.
X-ray imaging shows mild to moderate knee osteoarthritis (Kellgren-Lawrence grades 1-3).
Knee joint pain with a Visual Analogue Scale (VAS) score greater than 4.

Exclusion Criteria12

Severe knee osteoarthritis (Kellgren-Lawrence grade 4).
Currently systemic infection.
Received hyaluronic acid or corticosteroid intraarticular injections within the past six months, or received NSAIDs or oral corticosteroid treatment within 7 days prior to treatment.
The treated joint has undergone joint replacement surgery or major surgery.
Severe knee deformity or instability.
Known history of cancers, rheumatoid arthritis, platelet dysfunction, thrombocytopenia, hypofibrinogenemia, acute or chronic infectious diseases, chronic liver disease, or poorly controlled cardiovascular disease or diabetes.
Currently receiving anticoagulant therapy.
Long-term or excessive use of aspirin or vitamin E.
History of HIV/AIDS, syphilis, or other legally notifiable infectious diseases.
Pregnant or breastfeeding women, or women and men of childbearing potential who are unable to use effective contraception during the treatment period.
Deemed unsuitable for participation in the trial by the principal investigator.
Unable to sign the informed consent form.