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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Cluj
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Cluj-Napoca, Cluj, Romania, 400347
- " Iuliu Hatieganu" University of medicine and Pharmacy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity
Tidsramme: Baseline and at 4 weeks
|
Pain intensity assessed using the Visual Analogue Scale (VAS)
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Baseline and at 4 weeks
|
|
Functional status and symptom severity
Tidsramme: Basline and at 4 weeks
|
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
|
Basline and at 4 weeks
|
|
Systemic inflammatory markers
Tidsramme: Baseline and at 4 weeks
|
Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α
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Baseline and at 4 weeks
|
|
General inflammatory indicators
Tidsramme: Baseline and at 4 weeks
|
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
|
General inflammatory indicators: C-reactive protein (CRP)
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Baseline and at 4 weeks
|
|
Growth factor profile of PRP
Tidsramme: Baseline
|
transforming growth factor beta (TGF-β), platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF)
|
Baseline
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- Muskel- og skjelettsykdommer
- Leddgikt
- Leddsykdommer
- Revmatiske sykdommer
- Artrose
- Undersøkelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Celletall
- Cytologiske teknikker
- Hematologiske tester
- Cellefysiologiske fenomener
- Blodfysiologiske fenomener
- Sirkulasjons- og luftveisfysiologiske fenomener
- Blodplatefunksjonstester
- Blodcelleantall
- Blodplatetall
Andre studie-ID-numre
- IuliuHatieganuUniversity
Plan for individuelle deltakerdata (IPD)
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