Platelet-Rich Plasma Composition and Clinical Effects in Knee Osteoarthritis

NCT07558980 | Completed

• 1 other identifier: IuliuHatieganuUniversity
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Arthritis, Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets

OTHER

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

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

Interventions

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

intraarticular injection

40 patients with knee arthrosis receiving an infiltration with plasma rich in platelets

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

" Iuliu Hatieganu" University of medicine and Pharmacy

Cluj-Napoca, Cluj, 400347, Romania

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: April 30, 2026
• Study Start: October 15, 2025
• Primary Completion: November 20, 2025
• Study Completion: December 20, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

RO (1)