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

• Status: Not yet recruiting
• Trial end date: 2024-08-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RegenLab France SAS
• Treatments: Hylan

Criteria

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)

• Rheumatological conditions other than osteoarthritis

• 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 3 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)

• Patient with a serious pathology (cardiovascular pathology, active peptic ulcer digestive haemorrhage)

• Acute infection

• Immunocompromised patient

• 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