Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis

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).

Inclusion Criteria:Tibiofemoral knee osteoarthrosis according to ACR criteriaTibiofemoral 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 entryPatient able to read and understand the written instructionsPatient able to complete the self-assessment questionnairesExclusion Criteria:Tibiofemoral knee osteoarthrosis grade I or II according to the Kellgren and Lawrence grading scaleKnee surgery planned in the next 6 monthsPatient affected by autoimmune disease (rheumatoid arthritis, lupus, Hashimoto's disease and Bechterew's syndrome)Rheumatological conditions other than osteoarthritisPatient affected by a knee infection in the past 6 monthsClinical signs of local knee inflammation (redness or warmth of the knee joint)Last PRP or PRP/HA injection received in the last yearLast viscosupplementation received in the past 3 monthsLast corticosteroid injection received in the past 3 monthsUse of gluco-corticosteroids (except inhaled) and level III analgesics in the last 3 months and non-steroidal anti-inflammatory drug in the last 2 weeksTreatment with AAAL initiated within the last 6 monthsHistory of allergy to hyaluronic acidHematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia)Patients with coagulation times outside the reference valuesAnemia (HGB<10 g/dl)Venous or lymphatic stasis in the corresponding limbMalignant diseases (especially bone or haematological)Patient with a serious pathology (cardiovascular pathology, active peptic ulcer digestive haemorrhage)Acute infectionImmunocompromised patientParticipation in another clinical trial for osteoarthritis of the knee in the last yearParticipation in another clinical trial, ongoing or completed within the last 3 monthsPatient 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 studyPregnant or breastfeeding women or women who expect to become pregnant during the studyAny other reason which may interfere with the proper conduct of the study, in the investigator's opinion