무릎 골관절염에 대한 PL과 PRP의 효과 비교: 전향적, 무작위, 위약 대조 시험
무릎 골관절염에 대한 혈소판 용해물과 혈소판 풍부 혈장 간의 효과 비교: 전향적, 무작위, 위약 대조 시험
This study will focus on grade I to III knee osteoarthritis by randomized controlled trials which comparing the effectiveness between placebo, autologous platelet rich plasma and autologous platelet lysate injections.
연구 개요
상세 설명
The current methods for treating knee osteoarthritis include delaying the disease progression and joint replacement surgery. The usual treatment methods are mostly temporary, such as taking drug and hyaluronic acid injection. Therefore, finding the safe and effective methods will greatly reduce medical resource, medical expenses and surgery cost, etc., and restore the patient's quality of life. Platelet lysate is the product of complete activation from autologous platelet. It contains rich growth factors and cytokines such as PDGF, TGF-β, VEGF, EGF and IGF, etc. It can support cell growth and doesn't have any white blood cells in it. It is superior to the platelet rich plasma because of reducing the overall inflammatory response and pain of the patient during treatment.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: WU Chueh-Hung, MD, CIPS
- 전화번호: 66473 0223123456
- 이메일: nojred@gmail.com
연구 연락처 백업
- 이름: Wang Tyng-Guey, MD
- 전화번호: 67588 0223123456
- 이메일: tgw@ntu.edu.tw
연구 장소
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Taipei, 대만, 100
- 모병
- National Taiwan University Hospital
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연락하다:
- Wu Chueh-hung, MD,CIPS
- 전화번호: 66473 0223123456
- 이메일: nojred@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 50 to 80 years old
- Study Subjects must be willing to sign Informed Consent to participate in the study
- In the past month, at least seven consecutive days in the squat, standing, walking or going up and down the stairs, the most serious degree of visual analogy of the knee pain (Visual Analogue Scale) is greater than or equal to 40 (the most pain is 100, not painful is 0)
- Morning joint stiffness is less than 30 minutes
- X-ray：Grade 1-3 radiographic OA as defined by the K-L classification
Exclusion Criteria:
- Knee instability
- The knee joint is obviously deformed (> 5 degree valgus or varus deviation on X-ray)
- Clinical diagnosed as Pes tendinitis, Chondromalacia
- Taking NSAIDs or steroids (including oral and injection) within one week
- Using anticoagulant drugs for a long time
- Platelet count is less than 150,000 / UL, or coagulation disorders, prothrombin time (PT value) is less than 11 seconds or greater than 16 seconds
- Leukemia, sepsis, platelet dysfunction or other blood related diseases
- tumors, infections or the trauma before the same site
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Saline injection
Sodium Chloride injection into the study knee joint every 4 weeks for a total of 3 injections |
5ml Placebo infusion of 0.9% Sodium Chloride |
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실험적: PRP injection
PRP injection into the study knee joint every 4 weeks for a total of 3 injections |
Device: "Aeon" Acti-PRP 5ml autologous platelet rich plasma injection |
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실험적: PL injection
PL injection into the study knee joint every 4 weeks for a total of 3 injections Platelet lysate is the product of nature activation from autologous platelet. |
Device: "Aeon" Acti-PRP 5ml autologous platelet lysate injection |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain score of the patient
기간: up to 24 weeks after surgery
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Using Visual Analog Score (from 0 to 10, 0 indicate no pain and 10 indicate maximal pain) to evaluate pain of surgical wound of the patient |
up to 24 weeks after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Knee functional score
기간: up to 24 weeks after surgery
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Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
up to 24 weeks after surgery
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X-ray
기간: up to 24 weeks after surgery
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Knee X-ray image |
up to 24 weeks after surgery
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Ultrasonic image
기간: up to 24 weeks after surgery
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Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle |
up to 24 weeks after surgery
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adverse events
기간: up to 24 weeks after surgery
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adverse events in clinical trial |
up to 24 weeks after surgery
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공동 작업자 및 조사자
수사관
- 연구 책임자: Wu Chueh-Hung, MD, CIPS, National Taiwan University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .