Clinical response to intra-articular injections of hylan G-F 20 in symptomatic hip osteoarthritis: the OMERACT-OARSI criteria applied to the results of a pilot study - 05/01/07
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Supported by Genzyme Biosurgery, Gooimeer 10, 1411 DD Naarden, The Netherlands (formerly Biomatrix Inc, 65 Railroad Ave., Ridgefield, NJ 07657, USA)
Abstract |
Objective |
To assess, using the OMERACT-OARSI criteria, the clinical response of patients presenting with symptomatic hip osteoarthritis (OA) to one intra-articular injection of hylan G-F 20.
Methods |
Open-label, multi-centre, prospective, pilot study. Fifty-six patients presenting with primary hip OA, Kellgren-Lawrence grade II-III, age≥40, with walking pain measuring 50-90 mm on a 100 mm visual analogue scale (VAS). Intra-articular injection of a single 2 ml dose of hylan G-F 20 into the hip joint under fluoroscopic guidance. A second injection could be administered at day (D) 30, 60 or 90 if pain was unchanged or returned to baseline levels.
Efficacy criteria |
The outcome of the first injection in the intent-to-treat (ITT) population was analysed 90 days after the injection in those patients that received a single injection, and on the day of the second injection in those patients that required two injections, using OMERACT-OARSI responder criteria (obtained from WOMAC A and C indices and the patient's global evaluation) and variation in walking pain on VAS.
Results |
The percentage of responders according to the OMERACT-OARSI response criteria was 53.6%. An inverse correlation was observed between reduction in pain and joint space narrowing score (P=0.03).
Conclusion |
In the absence of a control group, the efficacy of the treatment cannot be determined conclusively. Nevertheless these data suggest that hylan G-F 20 is a symptomatic treatment of hip OA, particularly in less severe radiological cases. A double-blind, controlled study is required to confirm these data.
Le texte complet de cet article est disponible en PDF.Keywords : OMERACT-OARSI, Hyaluronic acid, Hip osteoarthritis, Osteoarthritis treatment
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Vol 73 - N° 6
P. 705-709 - décembre 2006 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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