Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA
Recruiting · NCT06932614 · Interventional (participants receive a specific treatment) · Lead sponsor: Tri-Service General Hospital (TSGH)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- No. 325, Sec. 2, Chenggong Rd., Neihu Dist. - Taipei, Taiwan