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- Alberto Migliore, Sandro Tormenta, Umberto Massafra, Emanuele Bizzi, Francesca Iannessi, Andrea Alimonti, and Mauro Granata.
- U.O.S. of Rheumatology, Ospedale San Pietro Fatebenefratelli, Rome, Italy. albertomigliore@terra.es
- Curr Med Res Opin. 2008 May 1; 24 (5): 1309-16.
ObjectiveThis prospective, observational, open study aimed to assess the efficacy and safety of hylan G-F 20 in a large cohort of patients with symptomatic hip osteoarthritis (OA), and identify predictors of clinical response.Research Design And MethodsPatients presenting with symptomatic hip OA received one 2 mL intra-articular (IA) injection of hylan G-F 20 under ultrasound guidance. Patients were followed-up every 3 months for a total of 12 months and were offered an optional, additional injection at each follow-up visit if symptomatically justified. At each visit, pain scores (100 mm visual analogue scale [VAS]), Lequesne index scores, NSAID intake, and physician and patient global assessments scores were recorded. Adverse events (AEs) were recorded throughout the study. MAIN OUTCOME MEASURES;Results250 patients completed the 12 month follow-up and received a total of 734 injections. Statistically significant reductions in VAS pain scores, Lequesne index scores and NSAID usage were reported at all time-points (p < 0.05). No systemic, serious or severe side effects were observed. Fifty-two local AEs were reported (7.08% per injection) all of which were mild and transient. One predictor of clinical response was identified, with patients < 75 years of age reporting better outcomes.ConclusionsThis study supports the safety, tolerability and effectiveness of hylan G-F 20 in the treatment of symptomatic hip OA. Hylan G-F 20 may also offer economic benefits due to a reduction in NSAID usage and the resultant reduction in management costs of NSAID related side-effects. These data reflect those obtained in previous studies of hylan G-F 20 in patients with knee OA.
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