Platelet-Rich Plasma(PRP): Knee Intraarticular injection with Lyophilized self growth factor
Placebo: Knee Intraarticular injection with normal saline
Study 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
Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Western Ontario and McMaster Universities Osteoarthritis Index — Pre-treatment, 1st month, 2nd month, 3rd month, 6th month The structure and function of the knee joint are assessed from three main aspects: pain, stiffness, and joint function, with a total of 24 items. The pain section consists of 5 items (24 points in total), the stiffness section has 2 items (8 points in total), and the joint function section includes 17 items (68 points in total). A lower score indicates more severe pain, stiffness, and a higher degree of disability.
Trial sites (1)
Facility
City
Region
Status
No. 325, Sec. 2, Chenggong Rd., Neihu Dist.
Taipei
Taiwan
Recruiting
More Tri-Service General Hospital (TSGH) trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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