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L'essai clinique NCT06932614 pour Arthrose du genou, PRP Injection est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Comparing the Efficacy of Lyophilized Self Growth Factor Versus PRP Injection for Knee OA
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L'étude clinique NCT06932614 est un essai interventionnel pour Arthrose du genou, PRP Injection. Son statut actuel est : en recrutement. L'étude a débuté le 1 août 2025 et vise à recruter 90 participants. Dirigé par Tri-Service General Hospital, l'essai devrait être terminé d'ici le 31 juillet 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 septembre 2025.
Résumé succinct
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.
Description détaillée
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.
Titre officiel
Comparing the Efficacy of Lyophilized Self Growth Factor Versus Platelet-Rich Plasma(PRP) Injection for Knee Osteoarthritis: A Prospective, Double-Blind, Randomized Controlled Trial
Conditions
Arthrose du genouPRP InjectionPublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Autres identifiants de l'essai
- C202404004
Numéro NCT
Date de début (réel)
2025-08-01
Dernière mise à jour publiée
2025-09-10
Date de fin (estimée)
2026-07-31
Inscription (estimée)
90
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Knee Osteoarthritis
PRP injection
PRP injection
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalLyophilized self growth factor Knee Intraarticular injection with Lyophilized self growth factor | Lyophilized Self Growth Factor Knee Intraarticular injection with Lyophilized self growth factor |
Comparateur actifPlatelet-Rich Plasma(PRP) Knee intraarticular injection with Platelet-Rich Plasma(PRP) | Platelet-rich Plasma(PRP) Knee Intraarticular injection with Lyophilized self growth factor |
Comparateur placebonormal saline Knee intraarticular injection with normal saline | PLACEBO Knee Intraarticular injection with normal saline |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Western Ontario and McMaster Universities Osteoarthritis Index | 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. | Pre-treatment, 1st month, 2nd month, 3rd month, 6th month |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Visual Analogue Scale | Change from baseline of pain on 1st month, 2nd month, 3rd month, 6th month after injection.
Pain severity was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain | Pre-treatment, 1st month, 2nd month, 3rd month, 6th month |
The intermittent and constant pain score , ICOAP | The content is divided into two subcategories: continuous pain (5 items) and intermittent pain (6 items), with a total of 11 items. Each item is scored from 0, representing no pain, to 4, representing extreme pain. A higher score indicates more severe pain. The Chinese version has reliable validity and reliability. | Pre-treatment, 1st month, 2nd month, 3rd month, 6th month |
Timed Up and Go test | Align the chair legs with the starting baseline and place a cone 3 meters ahead. The participant sits in the chair with their feet naturally bent, stands up comfortably, walks forward for 3 meters, turns around, and walks back to sit down. The time taken to complete the task is recorded. This test has good validity and reliability for assessing the mobility of patients with degenerative knee osteoarthritis. | Pre-treatment, 1st month, 2nd month, 3rd month, 6th month. |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
20 Years
Sexes éligibles
Tous
- 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.
- 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.
Partie responsable de l'essai
Yu-CHI Su, Investigateur principal, Attending Physician and lecturer of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Contact central de l'essai
Contact: Yu Chi Su,, MD, +886287923311, [email protected]
1 Centres de l'essai dans 1 pays
No. 325, Sec. 2, Chenggong Rd., Neihu Dist., Taipei, 114, Taiwan
Yu Chi Su, MD, Contact, +886-2-8792-3311, [email protected]
En recrutement