Active, not recruiting
Not applicable
Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
Condition(s) studied
Knee Osteoarthritis
Investigational drug(s) / intervention(s)
Regen Matrix-PRP-XLHAHylan G-F 20Placebo
Regen Matrix-PRP-XLHA: Single intra-articular injection at Day 0
Hylan G-F 20: Single intra-articular injection at Day 0
Placebo: Single intra-articular injection at Day 0
Study 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).
Eligibility
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
Primary outcome measure(s)
- Variation in the osteoarthritis related pain — 6 months (Day 0 - Month 6)
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
Trial sites (13)
| Facility | City | Region | Status |
| Hopital Le Bocage Chru |
Dijon |
DE |
|
| Centre Hospitalier Sud-Francilien |
Corbeil-Essonnes |
France |
|
| CHU Henri Mondor APHP |
Créteil |
France |
|
| Centre Hospitalier Départemental Vendée |
La Roche-sur-Yon |
France |
|
| CHU Limoges |
Limoges |
France |
|
| Centre Hospitalier Lyon Sud |
Lyon |
France |
|
| Hopital Lapeyronie |
Montpellier |
France |
|
| CHU Nantes Hôtel - Dieu |
Nantes |
France |
|
| Ch de Narbonne |
Narbonne |
France |
|
| Hôpital Lariboisière |
Paris |
France |
|
| Hôpital Saint-Antoine |
Paris |
France |
|
| Hopital Maison Blanche |
Reims |
France |
|
| Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis |
Toulouse |
France |
|
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