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

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for knee osteoarthritis, which is a condition that causes pain and stiffness in the knee joint. The study is called "PRP+HA-23," and it aims to compare three different treatment options: a combination of two substances called Platelet-Rich Plasma (PRP) and Hyaluronic Acid (HA), just PRP alone, and just HA alone. Researchers want to find out which of these options works best to relieve pain and improve knee function for patients aged 40 to 75 who have moderate to severe knee pain and have not found relief from other treatments.

To be eligible for the trial, participants must have knee osteoarthritis that affects one knee and causes enough pain to score between 3 and 8 on a pain scale. They should also have tried other treatments without success and meet certain health criteria, such as having enough healthy blood levels. The trial is not recruiting participants yet, but those who join can expect to receive one of the three treatments and regular follow-up care to monitor their progress. It's important to note that some individuals, such as those with certain serious health conditions or recent surgeries, will not be able to participate.

Gender

ALL

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.