ab21506

Intra-articular injections of hylan G-F 20 in patients with symptomatic hip osteoarthritis: An open-label, multicentre, pilot study

T. Conrozier¹, P. Bertin², P. Mathieu¹, J. Charlot³, F. Bailleul⁴, R. Treves², E. Vignon¹, X. Chevalier³

¹Department of Rheumatology, Centre Hospitalier Lyon-sud, Pierre-bénite; ²Department of Rheumatology, Centre Hospitalier Dupuytren, Limoges; ³Department of Rheumatology, Centre Hospitalier Henri Mondor, Créteil; France; ⁴Genzyme Biosurgery, Europe

ABSTRACT
Objective
To obtain prospective data on feasibility and safety of intra-articular injections of hylan G-F20 in patients with symptomatic hip osteoarthritis (OA).

Methods
Fifty-seven patients with primary hip OA, Kellgren-Lawrence grade II-III, aged ³ 40 and walking pain 50-90 mm on a visual analogue scale (VAS) were enrolled in an open-label, multicentre pilot trial. Hylan G-F20 (2 ml) was injected intra-articularly (IA) in the hip under fluoroscopy at D0, and follow-up visits were performed at D7-30-60-90. The possibility of a second injection at D30-60 or 90 was considered if the reported pain level was equivalent to baseline. Adverse events, walking pain (VAS), WOMAC index, patient and physicianÕs global assessment were recorded at each visit.

Results
Twenty-five patients received 1 injection and 32 received 2 injections.Transient hip pain was reported following 10.1% of injections, but no patient withdrew from the study because of this. Two mild synovial fluid aseptic effusions occurred after the first injection. No systemic device-related adverse event was reported. Walking pain decreased from 69.3 mm at entry to 39.5 mm at the end point (p < 0.0001). All other outcome measures decreased significantly.

Conclusion
Viscosupplementation with hylan G-F20 is feasible, easy to perform and well-tolerated in hip OA. A double-blind, controlled study should be performed to confirm data on its efficacy.

Key words
Hyaluronic acid, hip osteoarthritis, and osteoarthritis treatment.

Supported by Genzyme Biosurgery, Gooimeer 10, 1411 DD Naarden, The Netherlands (formerly Biomatrix Inc, 65 Railroad Ave., Ridgefield, NJ 07657, USA).
Please address correspondence and reprint requests to: Thierry Conrozier, MD, Service de rhumatologie, Centre hospitalier Lyon-Sud, 165 chemin du Grand-Revoyet, 69495 Pierre-Bénite cedex, France.
E-mail:thierry.conrozier@chu-lyon.fr