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MINERVA ORTOPEDICA E TRAUMATOLOGICA
A Journal on Orthopedics and Traumatology
Minerva Ortopedica e Traumatologica 2008 April;59(2):69-79
Intra-articular sodium hyaluronate (ARTHRUM® H 2.0%) in the treatment of patients with knee osteoarthritis: a multi-centric, randomized, comparative clinical trial
Arramon J. Y. 1, Bergamasco P. 2, Blasco G. 3, Vincent P. 4
1 Rheumatologist, Cenon, France
2 Clinique du Pont de Chaume Montauban, France
3 Physical & Rehabilitation Medical Doctor Ramonville, France
4 Scientific group, LCA Pharmaceutical Chartres, France
Aim. The aim of the present study was to determine efficacy and safety of intra-articular sodium hyaluronate ARTHRUM® H 2.0 % vs other hyaluronic acid (HA) based visco-supplement medical devices (SYNVISC® GF-20, OSTENIL®, ADANT® and SUPLASYN®), in the treatment of knee osteoarthritis.
Methods. This study was a multicentric comparative randomized prospective open clinical trial carried out over a period of six months, involving 11 centers and 496 patients treated from 2002 to 2004. Each patient received a serial of three injections of the same hyaluronic acid at one week interval, either ARTHRUM® H or the comparison HA product randomly selected. Evaluation was done at T0 (base line=before first injection) then at T3 and T6 (months) primarily with WOMAC index and secondarily with daily life impact scores and patient global assessment. The study enrolled 490 patients: 271 treated with ARTHRUM® H, 85 with SYNVISC® (Hylan G-F 20), 35 with OSTENIL®, 30 with ADANT® and 69 with SUPLASYN®.
Results. After six months, WOMAC functional index improved by 37% (P<0.01) for ARTHRUM® H, 31% (P<0.01) for SYNVISC® and 32% (P<0.01) for the others. Similarly WOMAC pain score improved by 41% (P<0.01) for ARTHRUM® H, 28% (P<0.01) for SYNVISC® and 26% (P<0.01) for the others. After six months concomitant treatments have been discontinued for 33% of patients with ARTHRUM® H, 13% of patients with SYNVISC® and for 21% of patients with the others.
Conclusion. The clinical results obtained with ARTHRUM® H appear significantly better and longer lasting than those obtained with the other products.