Platelet-Rich Plasma Composition and Clinical Effects in Knee Osteoarthritis
Study of the Composition of Platelet-rich Plasma and Its Clinical and Molecular Effect in the Biological Treatment of Knee Arthrosis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study is designed as an observational, longitudinal, prospective cohort investigation focused on patients with primary degenerative pathology of the knee joint, specifically primary gonarthrosis. The target population includes individuals diagnosed with knee osteoarthritis, while the accessible population consists of patients admitted to the Clinical Rehabilitation Hospital in Cluj-Napoca.
A total of 40 consecutive patients meeting inclusion criteria will be enrolled. Each participant will undergo treatment consisting of an intra-articular injection of platelet-rich plasma (PRP) at the knee level. The consecutive inclusion approach reduces selection bias and reflects routine clinical practice.
A central component of the study is the biological characterization of PRP. The investigators will analyze its composition, particularly focusing on growth factors such as platelet-derived growth factor (PDGF), transforming growth factor beta 1 (TGF-β1), and insulin-like growth factor 1 (IGF-1). This analysis is intended to contribute to the standardization of PRP therapy in knee osteoarthritis.
In parallel, the study will assess systemic inflammatory status by measuring circulating biomarkers, including interleukins (IL-1β, IL-8, IL-18) and tumor necrosis factor alpha (TNF-α). Monitoring these biomarkers allows evaluation of the inflammatory response and provides insight into the biological effects of PRP on the intra-articular environment.
Overall, the study seeks to clarify both the pathophysiological mechanisms underlying knee osteoarthritis and the therapeutic mechanisms of PRP, while also assessing its clinical effectiveness through changes in inflammatory markers.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Cluj
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Cluj-Napoca, Cluj, Rumænien, 400347
- " Iuliu Hatieganu" University of medicine and Pharmacy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age between 40 and 80 years
- Diagnosis of unilateral or bilateral gonarthrosis radiological grade 2-3 Kellgren-Lawrence
- Knee joint pain greater than 4 on the VAS scale
- History of knee joint pain for at least 6 months
- Patients who are to receive an inpatient PRP injection
Exclusion Criteria:
- Diagnosis of secondary gonarthrosis
- History of inflammatory rheumatological disease or gout
- History of recent minor (1 month) or major (2 years) trauma to the knee joint
- History of knee surgery or arthroscopy
- Infiltrations, physiotherapy or other knee treatments in the last 3 months
- Diagnosis of neoplasia, hematological or immunological diseases
- Clinical or biological signs of acute infection
- Coagulation disorders
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: 40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets
intra-articular administration of plasma rich in platelets (PRP)
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intraarticular injection
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity
Tidsramme: Baseline and at 4 weeks
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Pain intensity assessed using the Visual Analogue Scale (VAS)
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Baseline and at 4 weeks
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Functional status and symptom severity
Tidsramme: Basline and at 4 weeks
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Functional status and symptom severity measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaire Health-related quality of life evaluated with the SF-36 questionnaire
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Basline and at 4 weeks
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Systemic inflammatory markers
Tidsramme: Baseline and at 4 weeks
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Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α
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Baseline and at 4 weeks
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General inflammatory indicators
Tidsramme: Baseline and at 4 weeks
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General inflammatory indicators: erythrocyte sedimentation rate (ESR)
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Baseline and at 4 weeks
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General inflammatory indicators 2
Tidsramme: Baseline and at 4 weeks
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General inflammatory indicators: C-reactive protein (CRP)
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Baseline and at 4 weeks
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Growth factor profile of PRP
Tidsramme: Baseline
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transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF)
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Baseline
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Gigt
- Ledsygdomme
- Reumatiske sygdomme
- Slidgigt
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Celletælling
- Cytologiske teknikker
- Hæmatologiske tests
- Cellefysiologiske fænomener
- Blodfysiologiske fænomener
- Cirkulations- og respiratoriske fysiologiske fænomener
- Blodpladefunktionstest
- Tælling af blodlegemer
- Blodpladetælling
Andre undersøgelses-id-numre
- IuliuHatieganuUniversity
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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