10 years of real-world data: long-term efficacy and safety of HyalOne® for hip osteoarthritis.

Abstract

Background: Hip osteoarthritis (OA) is a leading cause of disability in older adults, yet long-term, non-surgical treatment options remain limited. Viscosupplementation with intra-articular hyaluronic acid has shown promise, but evidence for its sustained efficacy in hip OA is scarce. This study evaluates the 10-year efficacy and safety of repeated ultrasound (US)-guided injections of HyalOne^®/Hyalubrix^® 60 in patients with symptomatic hip OA.

Methods: A retrospective, observational, open-label study was conducted on 681 patients with symptomatic hip OA treated with HyalOne^® between 2010 and 2013, with follow-up through 2023. Patients received one US-guided intra-articular injection every 6 months, with additional injections as needed. Pain and functional outcomes were assessed using the Visual Analogue Scale and the Lequesne Index. Non-steroidal anti-inflammatory drug (NSAID) consumption and adverse events were also monitored.

Results: Overall, 481 patients completed the 10-year follow-up. Pain reduction was observed across all age and body mass index groups, with the highest improvement in patients under 40 years old (-54.3%). Functional status improved significantly, with the greatest reduction in Lequesne Index scores observed in patients over 80 years old (-32.5%). NSAID use decreased by 84% in younger patients and by 62-71% in older patients or those with obesity. No major systemic adverse events were reported, and transient local reactions occurred in 4% of patients.

Conclusions: This study provides the first real-world evidence of the sustained efficacy and safety of a 10-year US-guided HyalOne^® injection regimen in managing hip OA, highlighting significant improvements in pain, function and NSAID reduction across diverse patient populations.