Abstract
INTRODUCTION: Intra-articular (i.a.) hyaluronic acid is an accepted conservative therapy for knee osteoarthritis (OA). This study evaluated the safety and efficacy of a single i.a. injection of an innovative formulation of sodium hyaluronate 2.4% plus sodium chondroitin non-sulphated 1.6% of biotechnological origin (HA-SC) for the treatment of patients with radiographically confirmed symptomatic hip OA and moderate-to-severe pain. METHODS: In this prospective, multicenter, open-label, pilot study, HA-SC was administered using a standard ultrasound-guided procedure. Adverse events, global/local evaluation of tolerability, and use of rescue analgesics were recorded. Efficacy endpoints included visual analogue scale (VAS) measurement of hip pain, changes in Lequesne's algofunctional Index, and assessment of global status. RESULTS: Treatment was well tolerated; adverse device events of moderate-to-severe intensity, most commonly, injection site pain/localized arthralgia occurred in 20.8% of subjects. Global evaluation of tolerability was rated as excellent or good (75.0%), fair (16.7%), and poor (8.3%) by subjects and 77.1, 14.6, and 8.3%, respectively, by investigators. There was a rapid and significant decrease in hip pain after a single injection; VAS pain score decreased from a mean of 67.5 mm at baseline to 29.3 mm by day 7, with the effects sustained during 6 months of follow-up (P < 0.0001). There were significant improvements in Lequesne's Index for hip OA total scores at all time points during follow-up (P < 0.0001). The majority of subjects reported 'Very much improved' or 'Slightly improved' global improvement at any time point. Use of rescue paracetamol was generally low. CONCLUSIONS: A single i.a. injection of an innovative HA-SC formulation was well tolerated, safe, and effective in the treatment of symptomatic hip OA.