NCT06685120 Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis
| NCT ID | NCT06685120 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Osteo Arthritis Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2025-12-11 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
"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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients, aged 40 to 75 years; 2. Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8); 3. Unilateral involvement of symptomatology; 4. Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3); 5. Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment); 6. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination); 7. Ability and consent of patients to actively participate in clinical follow-up; 8. Signature of informed consent. Exclusion Criteria: 1. Patients unable to express consent; 2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months; 3. Patients undergoing knee surgery in the previous 12 months; 4. Patients with malignant neoplasms; 5. Patients with rheumatic diseases; 6. Patients with uncontrolled diabetes; 7. Patients with hematological diseases (coagulopathies); 8. Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection; 9. Patients with uncompensated thyroid metabolic disorders; 10. Patients abusing alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35; 12. Patients who have taken NSAIDs in the 3 days prior to blood draw; 13. Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated; 14. Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3. 15. Pregnant and/or fertile women.
Contact & Investigator
Davide Reale, MD
PRINCIPAL INVESTIGATOR
Istituto Ortopedico Rizzoli - Argenta
Frequently Asked Questions
Who can join the NCT06685120 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Osteo Arthritis Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06685120 currently recruiting?
Yes, NCT06685120 is actively recruiting participants. Contact the research team at davide.reale@ior.it for enrollment information.
Where is the NCT06685120 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy.
Who is sponsoring the NCT06685120 clinical trial?
NCT06685120 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Davide Reale, MD at Istituto Ortopedico Rizzoli - Argenta. The trial plans to enroll 288 participants.