Multicenter, Randomized Double-blind Study to Compare the Safety and Performance of a Combination of A-PRP and XLHA Prepared With the RegenMatrix Medical Device, to Hylan G-F 20 XLHA and Placebo to Treat Moderate/Severe Knee Osteoarthritis

2022-A01514-39

In this clinical trial the investigator assess the safety and efficacy of a single injection of a combination of cross-linked hyaluronic acid (HA) with autologous platelet-rich plasma (PRP) obtained with the RegenMatrix medical device to improve symptoms of moderate to severe knee osteoarthitis (grade III-IV Kellgren-Lawrence).

2023-08-21

2025-02-21

2025-08-21

Recruiting

280

Inclusion Criteria: * Tibiofemoral knee osteoarthrosis according to ACR criteria * Tibiofemoral knee osteoarthrosis grade 3-4 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 3 months old: face view, schuss view, profile and patellar axial view at 30°) * Symptomatic knee osteoarthrosis as evidenced by pain on walking (WOMAC A1 assessed in the last 24 hours on a scale of 0 to 100 mm: 50 ≤ DM 90 or reduced joint function (WOMAC C total score assessed or within the previous 24 hours based on a scale of 0-100-mm: 50 ≤ WOMAC C ≤ 90) * Patient able to understand the requirements of the trial and who has signed a free and informed consent prior to study entry * Patient able to read and understand the written instructions * Patient able to complete the self-assessment questionnaires Exclusion Criteria: * Tibiofemoral knee osteoarthrosis grade I or II according to the Kellgren and Lawrence grading scale * Knee surgery planned in the next 6 months * Patient affected by autoimmune disease (rheumatoid arthritis, lupus, Hashimoto's disease and Bechterew's syndrome) * Chronic inflammatory rheumatism other than arthritis (polyarthrosis, etc.) * Patient affected by a knee infection in the past 6 months * Clinical signs of local knee inflammation (redness or warmth of the knee joint) * Last PRP or PRP/HA injection received in the last year * Last viscosupplementation received in the past 6 months * Last corticosteroid injection received in the past 3 months * Use of gluco-corticosteroids (except inhaled) and level III analgesics in the last 3 months and non-steroidal anti-inflammatory drug in the last 2 weeks * Treatment with AAAL initiated within the last 6 months * History of allergy to hyaluronic acid * Hematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia) * Patients with coagulation times outside the reference values * Anemia (HGB\<10 g/dl) * Venous or lymphatic stasis in the corresponding limb * Malignant diseases (especially bone or haematological) * Patients with serious, no-stabilized pathologies (cardiovascular disease, active peptic ulcer, digestive hemorrhage) * Acute infection * Patients with cancer or with an immuno-deprassant treatment ongoing * Participation in another clinical trial for osteoarthritis of the knee in the last year * Participation in another clinical trial, ongoing or completed within the last 3 months * Patient unable to comply with the constraints of the protocol, in particular a patient whose mental state does not allow him/her to patient's mental state does not allow him/her to understand the nature, objectives and possible consequences of the study * Pregnant or breastfeeding women or women who expect to become pregnant during the study * Any other reason which may interfere with the proper conduct of the study, in the investigator's opinion

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

2023-08-28