Overview
"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.
Description
Patients with osteoarthritis of the knee will be included in a randomized controlled, double-blind study, in which one group of patients will be treated with an infiltration of PRP combined with HA (PRP + HA group), one group of patients will be treated with an infiltration of PRP alone (PRP group), and another group of patients will be treated with an infiltration of HA alone (HA group). They will be "blinded" patients, health care professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.
A total of 288 patients will be included, and they will undergo infiltrative treatment after collecting informed consent for study participation and biographical data.
All enrolled patients undergo transfusion evaluation and venous whole blood sampling from 30 to 60 mL depending on the patient's hematocrit. From the withdrawn blood, which will be collected in tubes of 9 mL each, fresh autologous PRP (PRP) will subsequently be obtained. To maintain study blinding, all patients will have their blood drawn but PRP will not be produced for patients randomized into the HA group.Following autologous PRP harvesting and production, patients randomized into the treatment group will undergo single intra-articular infiltration of PRP + HA; patients randomized into the control group 1, will undergo single intra-articular infiltration of PRP; and patients randomized into the control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blindness. They will then undergo an intra-articular infiltration of HA .Patients will be clinically evaluated before the infiltration procedure and at 1-3-6- 12 and 24 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checks during follow-up
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
