💬In plain words
What the trial is, and whether it could suit you
"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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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