The aim of this prospective observational study is to assess the efficacy and safety profile of intra-articular Sinovial® Forte 1.6% administered under ultrasound-guidance in a large cohort of patients affected by symptomatic hip osteoarthritis (OA). Patients with symptomatic hip OA referred to our clinic in 2008-2010 received one 4 ml (2 vials) intra-articular injection of Sinovial® Forte 1.6% under ultrasound guidance. Patients were followed-up every 3 months for a total of 6 months and were offered an optional, additional injection at the 3-month follow-up visit if clinically justified. At each visit, pain scores [0-10 Visual Analogue Scale (pain VAS)], Lequesne index scores and NSAID intake were recorded. Adverse events (AEs) were recorded throughout the study. An effect size of 30% and 50% reduction in Lequesne index and Pain VAS scores was evaluated for each patient to ascertain the number of patients achieving partial remission of symptoms and functional impairment by the use of intra-articular hyaluronic acid in hip osteoarthritis. One hundred and fourteen patients completed the 6-month follow-up and received a total of 142 injections. A statistically significant reduction in Lequesne index scores, VAS pain scores and NSAID consumption was observed at all time-points (p < 0.05). No systemic, severe or even moderate side effects were observed. Only 7 patients reported mild local reaction at the injection site, consisting of mild pain and localized warmth, which resolved spontaneously without any additional medication. This study provides evidence of the efficacy and tolerability of Sinovial® Forte 1.6% in the treatment of patients affected by symptomatic hip OA. Sinovial® Forte may also offer economical benefits, owing to the reduction in NSAID consumption associated with this treatment. The percentage of patients achieving the effect size of 30% and 50% reduction in Lequesne index and pain VAS scores encourages the use of intra-articular hyaluronic acid in patients with hip osteoarthritis. Copyright ©by BIOLIFE, s.a.s.
Intraarticular ultrasound-guided injection of sinovial® forte 1.6% in patients affected by symptomatic hip osteoarthritis: Effectiveness and safety in a large cohort of patients
PALMIERI, Annalisa;CARINCI, Francesco;ZOLLINO, Ilaria;ZAMBONI, Paolo;
2012
Abstract
The aim of this prospective observational study is to assess the efficacy and safety profile of intra-articular Sinovial® Forte 1.6% administered under ultrasound-guidance in a large cohort of patients affected by symptomatic hip osteoarthritis (OA). Patients with symptomatic hip OA referred to our clinic in 2008-2010 received one 4 ml (2 vials) intra-articular injection of Sinovial® Forte 1.6% under ultrasound guidance. Patients were followed-up every 3 months for a total of 6 months and were offered an optional, additional injection at the 3-month follow-up visit if clinically justified. At each visit, pain scores [0-10 Visual Analogue Scale (pain VAS)], Lequesne index scores and NSAID intake were recorded. Adverse events (AEs) were recorded throughout the study. An effect size of 30% and 50% reduction in Lequesne index and Pain VAS scores was evaluated for each patient to ascertain the number of patients achieving partial remission of symptoms and functional impairment by the use of intra-articular hyaluronic acid in hip osteoarthritis. One hundred and fourteen patients completed the 6-month follow-up and received a total of 142 injections. A statistically significant reduction in Lequesne index scores, VAS pain scores and NSAID consumption was observed at all time-points (p < 0.05). No systemic, severe or even moderate side effects were observed. Only 7 patients reported mild local reaction at the injection site, consisting of mild pain and localized warmth, which resolved spontaneously without any additional medication. This study provides evidence of the efficacy and tolerability of Sinovial® Forte 1.6% in the treatment of patients affected by symptomatic hip OA. Sinovial® Forte may also offer economical benefits, owing to the reduction in NSAID consumption associated with this treatment. The percentage of patients achieving the effect size of 30% and 50% reduction in Lequesne index and pain VAS scores encourages the use of intra-articular hyaluronic acid in patients with hip osteoarthritis. Copyright ©by BIOLIFE, s.a.s.I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
