Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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