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Platelet-rich plasma with hyaluronic acid injections for knee osteoarthritis

Compares combined, platelet-rich plasma-only and hyaluronic acid-only knee injections in people with knee osteoarthritis.

Key facts

Who runs it
Istituto Ortopedico Rizzoli
Where
Bologna, ItalySee the 2 sites
Trial code
Registry title
Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis
Status
Recruiting
People taking part
288 people, planned
Started
11 Dec 2025
Expected to end
Sept 2029
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • PRP + HA injection
  • PRP injection
  • HA injection
Record updated
3 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with painful knee osteoarthritis in one knee. Pain must still be there after other treatment. They get an injection of PRP, hyaluronic acid (HA), or both.

Age
40 to 75 years
Sex
Men and women
Disease stage
Symptomatic knee osteoarthritis in one knee only. Pain score (VAS) between ≥ 3 and ≤ 8. Cartilage wear on X-ray or MRI, Kellgren-Lawrence grade 1-3.
Earlier treatment
Symptoms must remain after at least one course of non-surgical treatment (medicines, physiotherapy or injections). No joint injection of another substance in the previous 6 months. No knee surgery in the previous 12 months. No NSAIDs in the 3 days before the blood draw.
Biomarker or test result
Hemoglobin > 11 g/dl and platelet count > 150,000 plt/mm3 on a recent blood count (CBC).

Main reasons for not taking part

  • Cancer, rheumatic disease, blood clotting disorders, uncontrolled diabetes or uncontrolled thyroid disorder
  • Blood thinners or anti-platelet drugs that cannot be stopped for the blood draw
  • Body Mass Index > 35
  • Heart or blood vessel disease that makes taking 30 to 60 ml of blood unsafe
  • Pregnant women or women who can have children; misuse of alcohol, drugs or medicines

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Male or female patients, aged 40 to 75 years
  • Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 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

Who cannot take part

  • Patients undergoing intra-articular infiltration of other substance in the previous 6 months
  • Patients undergoing knee surgery in the previous 12 months
  • Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection
  • Patients abusing alcoholic beverages, drugs or medications
  • Patients who have taken NSAIDs in the 3 days prior to blood draw
  • Patients with malignant neoplasms
  • Patients with rheumatic diseases
  • Patients with uncontrolled diabetes
  • Patients with hematological diseases (coagulopathies)
  • Patients with uncompensated thyroid metabolic disorders
  • 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
  • Patients unable to express consent
  • Body Mass Index > 35
  • Pregnant and/or fertile women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 75 years old?

Where in Italy

  • IRCCS Istituto ortopedico RizzoliBologna, ItalyContact: Davide Reale, MDNot yet recruiting
  • Istituto Ortopedico RizzoliBologna, ItalyContact: Davide Reale, MDTaking people

About the trial

What the trial wants to find out

"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.

The 3 groups in the trial

  • PRP+HA injectionTreatment being tested

    This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP+HA

  • PRP injectionExisting treatment, for comparison

    This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP

  • HA injectionExisting treatment, for comparison

    This group of patients randomized into the treatment group, will undergo single intra-articular injection of HA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis - Randomized Controlled Clinical Study
Plain-language title
Platelet-rich plasma with hyaluronic acid injections for knee osteoarthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06685120, who can take part
Record updated
3 February 2026