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

Tri-Service General Hospital

Status: Enrolling

Conditions: Knee Osteoarthritis; PRP Injection

Treatments: Procedure: Platelet-Rich Plasma(PRP); Procedure: Placebo; Procedure: Lyophilized self growth factor

Study type: Interventional

Funder types: Other

Identifiers

NCT06932614

C202404004

Details and patient eligibility

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.

Full description

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. Treatment options include weight loss, anti-inflammatory and pain-relieving medications, physical rehabilitation, and intra-articular injections of corticosteroids or hyaluronic acid. However, these methods often have limited efficacy or may cause side effects. 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. However, there is still lack of strong evidence of the therapeutic effects of PRP injection in knee OA. Therefore, there is a need to investigate novel therapies for 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. Patients with mild to moderate knee osteoarthritis who have experienced symptoms for more than three months. 30 participants will be recruited and randomly divided into three groups: the SRF group, the PRP group, and a control group. Each participant will receive knee intra-articular injections as part of a three-month treatment regimen, with one injection per month for a total of three injections. Patients will be evaluated before the trial, and at one, two, three, and six months after the injections. Clinical outcomes will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Intermittent and Constant Osteoarthritis Pain (ICOAP) scale, the sit-to-stand test, and the Visual Analog Scale (VAS) for pain. The study aims to confirm the clinical efficacy of SRF in treating degenerative knee osteoarthritis.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Lyophilized self growth factor

Experimental group

Description:

Knee Intraarticular injection with Lyophilized self growth factor

Treatment:

Procedure: Lyophilized self growth factor

Platelet-Rich Plasma(PRP)

Active Comparator group

Description:

Knee intraarticular injection with Platelet-Rich Plasma(PRP)

Treatment:

Procedure: Platelet-Rich Plasma(PRP)

normal saline

Placebo Comparator group

Description:

Knee intraarticular injection with normal saline

Treatment:

Procedure: Placebo