Clinical trial NCT06932614: Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA
Official title: Comparing the Efficacy of Lyophilized Self Growth Factor Versus Platelet-Rich Plasma(PRP) Injection for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
PRP Injection
Keywords: Knee Osteoarthritis
PRP injection
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
measure: The intermittent and constant pain score , ICOAP
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month
measure: Timed Up and Go test
timeFrame: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month.
Other outcomes:
Locations:
Study officials:
References:
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