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NCT Number: NCT07558980

Platelet-Rich Plasma Composition and Clinical Effects in Knee Osteoarthritis

This is a prospective, observational cohort study involving 40 patients with primary knee osteoarthritis hospitalized in a rehabilitation hospital in Cluj-Napoca. All participants will receive intra-articular platelet-rich plasma (PRP) injections. The study aims to analyze PRP composition and inflammatory biomarkers to better understand disease mechanisms and evaluate treatment effectiveness.

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Key information

Conditions

Knee Arthritis, Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

" Iuliu Hatieganu" University of medicine and Pharmacy

Cluj-Napoca, Cluj, 400347, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intra-articular administration of plasma rich in platelets (PRP)

Procedure

intraarticular injection

Primary outcomes

  1. Pain intensity

    Time frame: Baseline and at 4 weeks

    Pain intensity assessed using the Visual Analogue Scale (VAS)

  2. Functional status and symptom severity

    Time frame: 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

  3. Systemic inflammatory markers

    Time frame: Baseline and at 4 weeks

    Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α

  4. General inflammatory indicators

    Time frame: Baseline and at 4 weeks

    General inflammatory indicators: erythrocyte sedimentation rate (ESR)

  5. General inflammatory indicators 2

    Time frame: Baseline and at 4 weeks

    General inflammatory indicators: C-reactive protein (CRP)

  6. Growth factor profile of PRP

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Official study title

Study of the Composition of Platelet-rich Plasma and Its Clinical and Molecular Effect in the Biological Treatment of Knee Arthrosis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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