Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT06685120

Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis

Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-03

288

Participants Needed

2

Research Sites

194 weeks

Total Duration

On this page

Sponsors

I

Istituto Ortopedico Rizzoli

Lead Sponsor

U

University Hospital of Ferrara

Collaborating Sponsor

AI-Summary

What this Trial Is About

"PRP+HA-23" is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the treatment of patients with knee osteoarthritis.

CONDITIONS

Official Title

Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients, aged 40 to 75 years
  • Patients with symptomatic knee osteoarthritis (VAS pain score between �3e 3 and �3c= 8)
  • Unilateral involvement of symptomatology
  • Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3)
  • Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment)
  • Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC examination)
  • Ability and consent of patients to actively participate in clinical follow-up
  • Signature of informed consent
Not Eligible

You will not qualify if you...

  • Patients unable to express consent
  • Patients undergoing intra-articular infiltration of other substance in the previous 6 months
  • Patients undergoing knee surgery in the previous 12 months
  • Patients with malignant neoplasms
  • Patients with rheumatic diseases
  • Patients with uncontrolled diabetes
  • Patients with hematological diseases (coagulopathies)
  • Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection
  • Patients with uncompensated thyroid metabolic disorders
  • Patients abusing alcoholic beverages, drugs or medications
  • Body Mass Index > 35
  • Patients who have taken NSAIDs in the 3 days prior to blood draw
  • Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated
  • Patients with recently performed CBC examination with Hb< 11 g/dl and Platelet values < 150,000 plt/mm3
  • Pregnant and/or fertile women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Not Yet Recruiting

2

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

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Research Team

D

Davide Reale, MD

CONTACT

R

Roberta Licciardi, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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