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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Lyophilized self growth factor
  Knee Intraarticular injection with Lyophilized self growth factor
• Процедура Platelet-Rich Plasma(PRP)
  Knee Intraarticular injection with Lyophilized self growth factor
• Процедура Placebo
  Knee Intraarticular injection with normal saline

Первичные конечные точки

• Western Ontario and McMaster Universities Osteoarthritis Index [Срок оценки: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month]

Вторичные конечные точки (3)

• Visual Analogue Scale [Срок оценки: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month]
• The intermittent and constant pain score , ICOAP [Срок оценки: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month]
• Timed Up and Go test [Срок оценки: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• No. 325, Sec. 2, Chenggong Rd., Neihu Dist. — Taipei

Публикации

• Woodell-May J, Matuska A, Oyster M, Welch Z, O'Shaughnessey K, Hoeppner J. Autologous protein solution inhibits MMP-13 production by IL-1beta and TNFalpha-stimulated human articular chondrocytes. J Orthop Res. 2011 Sep;29(9):1320-6. doi: 10.1002/jor.21384. Epub 2011 Mar 15. PMID 21437966
• Jo CH, Kim JE, Yoon KS, Shin S. Platelet-rich plasma stimulates cell proliferation and enhances matrix gene expression and synthesis in tenocytes from human rotator cuff tendons with degenerative tears. Am J Sports Med. 2012 May;40(5):1035-45. doi: 10.1177/0363546512437525. Epub 2012 Feb 23. PMID 22366517
• Chavda S, Rabbani SA, Wadhwa T. Role and Effectiveness of Intra-articular Injection of Hyaluronic Acid in the Treatment of Knee Osteoarthritis: A Systematic Review. Cureus. 2022 Apr 26;14(4):e24503. doi: 10.7759/cureus.24503. eCollection 2022 Apr. PMID 35651409
• Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. doi: 10.1136/bmj.38039.573970.7C. Epub 2004 Mar 23. PMID 15039276
• Loeser RF, Goldring SR, Scanzello CR, Goldring MB. Osteoarthritis: a disease of the joint as an organ. Arthritis Rheum. 2012 Jun;64(6):1697-707. doi: 10.1002/art.34453. Epub 2012 Mar 5. No abstract available. PMID 22392533
• McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. PMID 24462672
• Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018. PMID 23973124

Идентификаторы

NCT: NCT06932614 · C202404004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗