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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthritis, Osteoarthritis
• Intervention / Treatment: Procedure: intra-articular administration of plasma rich in platelets (PRP)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400347
      • " Iuliu Hatieganu" University of medicine and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 40 and 80 years
2. Diagnosis of unilateral or bilateral gonarthrosis radiological grade 2-3 Kellgren-Lawrence
3. Knee joint pain greater than 4 on the VAS scale
4. History of knee joint pain for at least 6 months
5. Patients who are to receive an inpatient PRP injection

Exclusion Criteria:

1. Diagnosis of secondary gonarthrosis
2. History of inflammatory rheumatological disease or gout
3. History of recent minor (1 month) or major (2 years) trauma to the knee joint
4. History of knee surgery or arthroscopy
5. Infiltrations, physiotherapy or other knee treatments in the last 3 months
6. Diagnosis of neoplasia, hematological or immunological diseases
7. Clinical or biological signs of acute infection
8. Coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets; intra-articular administration of plasma rich in platelets (PRP)	Procedure: intra-articular administration of plasma rich in platelets (PRP); intraarticular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity assessed using the Visual Analogue Scale (VAS)	Baseline and at 4 weeks
Functional status and symptom severity	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	Systemic inflammatory markers: IL-1β, IL-8, IL-18, TNF-α	Baseline and at 4 weeks
General inflammatory indicators	General inflammatory indicators: erythrocyte sedimentation rate (ESR)	Baseline and at 4 weeks
General inflammatory indicators 2	General inflammatory indicators: C-reactive protein (CRP)	Baseline and at 4 weeks
Growth factor profile of PRP	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

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Actual): November 20, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Count; Cytological Techniques; Hematologic Tests; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Function Tests; Blood Cell Count; Platelet Count
• Other Study ID Numbers: IuliuHatieganuUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No