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).
In this multicenter, randomized, double-blind, three-arm study, the investigator propose to evaluate the safety and efficacy at Day0, Month1, Month3 and Month6 of a single intra-articular injection of a combination RM-PRP-XLHA (experimental treatment: combination of cross-linked HA and PRP obtained with the RegenMatrix medical device) against Hylan G-F 20 (reference treatment) and placebo for the treatment of moderate to severe knee osteoarthritis. The symptomatic benefit will be evaluated in terms of pain reduction and improvement of patient's quality of life. The functional benefit of the treatment will also be evaluated, on a reduced number of participants, by a gait analysis, performed only in the coordinating centre. The medical device RegenMatrix is an adaptation of the medical device Cellular Matrix (certified since 2013,CE2797). It differs from the latter only for by presence of cross-linked HA instead of linear HA, and is therefore particularly suitable for the treatment of moderate to severe knee osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
280
Single intra-articular injection at Day 0
Single intra-articular injection at Day 0
Single intra-articular injection at Day 0
Hopital Le Bocage Chru
Dijon, DE, France
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France
CHU Henri Mondor APHP
Créteil, France
Variation in the osteoarthritis related pain
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
Time frame: 6 months (Day 0 - Month 6)
Variation in the overall osteoarthritis related pain
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
Time frame: M1 and M3 (Day 0-Month 1; Day 0 - Month 3)
Variation of joint stiffness after the first awakening and later in the day
It will be assessed by the mean difference in the WOMAC B score overtime
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation of joint function during daily activity
It will be assessed by the mean difference in the WOMAC C score overtime
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation in the osteoarthritis related symptoms
It will be assessed by the mean difference in the total WOMAC score Month 1, Month 3 and M6 (D0-M1; D0-M3; D0-M6)
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation of patient's quality of life
It will be assessed by the SF-12 questionnaire
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Pain, function, patient's general assessment
It will be assessed by the% of OMERACT-OARSI responders
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 3 more locations
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Assessment of the minimal meaningful change according to the patient's perception
The Minimal Clinically Important Improvement (MCII) will be assessed on the basis of the answers to the WOMAC questionnaire.
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Assessment of the highest level of symptom beyond which patients consider themselves well.
The Patient Acceptable Symptom State (PASS) will be assessed on the basis of the answers to the WOMAC questionnaire.
Time frame: Month 1, Month 3 and Month 6 (D0-Month 1; Day 0-Month 3; Day 0-Month 6)
Rescue medication
Consumption of level 1 and 2 painkillers, NSAIDs and corticosteroids
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)