Sammenligning av effektivitet mellom PL og PRP på kneartrose: en prospektiv, randomisert, placebo-kontrollert prøvelse
Sammenligning av effektivitet mellom blodplatelysat og blodplaterikt plasma på kneartrose: en prospektiv, randomisert, placebokontrollert studie
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: WU Chueh-Hung, MD, CIPS
- Telefonnummer: 66473 0223123456
- E-post: nojred@gmail.com
Studer Kontakt Backup
- Navn: Wang Tyng-Guey, MD
- Telefonnummer: 67588 0223123456
- E-post: tgw@ntu.edu.tw
Studiesteder
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-
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
-
Ta kontakt med:
- Wu Chueh-hung, MD,CIPS
- Telefonnummer: 66473 0223123456
- E-post: nojred@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: 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 |
|
Eksperimentell: 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 |
|
Eksperimentell: 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain score of the patient
Tidsramme: up to 24 weeks after surgery
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Knee functional score
Tidsramme: up to 24 weeks after surgery
|
Using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
up to 24 weeks after surgery
|
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X-ray
Tidsramme: up to 24 weeks after surgery
|
Knee X-ray image |
up to 24 weeks after surgery
|
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Ultrasonic image
Tidsramme: up to 24 weeks after surgery
|
Ultrasonic-between thickness of the medial and lateral sides of the femoral condyle |
up to 24 weeks after surgery
|
|
adverse events
Tidsramme: up to 24 weeks after surgery
|
adverse events in clinical trial |
up to 24 weeks after surgery
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Wu Chueh-Hung, MD, CIPS, National Taiwan University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201803124RIPD
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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