Single-Dose Intra-Articular Administration of a Hybrid Cooperative Complex of Sodium Hyaluronate and Sodium Chondroitin
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ORIGINAL RESEARCH
Single-Dose Intra-Articular Administration of a Hybrid Cooperative Complex of Sodium Hyaluronate and Sodium Chondroitin in the Treatment of Symptomatic Hip Osteoarthritis: A Single-Arm, Open-Label, Pilot Study Rocco Papalia . Vincenzo Salini . Nicola Voglino . Mattia Fortina . Serafino Carta . Francesco Sadile . Cosimo Costantino Received: October 1, 2020 / Accepted: November 7, 2020 Ó The Author(s) 2020
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 nonsulphated 1.6% of biotechnological origin (HASC) for the treatment of patients with R. Papalia (&) Department of Orthopaedics and Traumatology, Campus Bio-Medico University of Rome, Rome, Italy e-mail: [email protected] V. Salini Department of Orthopaedics and Traumatology, San Raffaele Hospital, Vita-Salute University, Milan, Italy N. Voglino Orthopaedics and Trauma, Alto Tevere Hospital, Citta` di Castello, Perugia, Italy M. Fortina S. Carta Department of Orthopaedics and Traumatology, Siena University Hospital, Siena, Italy F. Sadile Division of Orthopaedic Service, Department of Public Health, ‘‘Federico II’’ Naples University Medical School, Naples, Italy C. Costantino Department of Medicine and Surgery, University of Parma, Parma, Italy
radiographically confirmed symptomatic hip OA and moderate-to-severe pain. Methods: In this prospective, multicenter, openlabel, 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
Rheumatol Ther
symptomatic hip OA. Keywords: Hip osteoarthritis; Hyaluronic acid; Intra-articular; Sodium chondroit
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