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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

En recrutement
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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 Injection
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
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
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/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
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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.
Tri-Service General Hospital logoTri-Service General Hospital
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