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临床试验/NCT06932614
NCT06932614招募中不适用

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

Tri-Service General Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Western Ontario and McMaster Universities Osteoarthritis Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female, aged over 20 and under
  • •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.

排除标准

  • •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.

研究组 & 干预措施

Lyophilized self growth factor

Experimental

Knee Intraarticular injection with Lyophilized self growth factor

干预措施: Lyophilized self growth factor (Procedure)

Platelet-Rich Plasma(PRP)

Active Comparator

Knee intraarticular injection with Platelet-Rich Plasma(PRP)

干预措施: Platelet-Rich Plasma(PRP) (Procedure)

normal saline

Placebo Comparator

Knee intraarticular injection with normal saline

干预措施: Placebo (Procedure)

结局指标

主要结局

Western Ontario and McMaster Universities Osteoarthritis Index

时间窗: Pre-treatment, 1st month, 2nd month, 3rd month, 6th month

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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-CHI Su

Attending Physician and lecturer of Department of Physical Medicine and Rehabilitation

Tri-Service General Hospital

研究点 (1)

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