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
| Autor: | Serafino Carta, Cosimo Costantino, Nicola Voglino, Mattia Fortina, Rocco Papalia, Vincenzo Salini, Francesco Sadile |
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| Přispěvatelé: | Papalia, Rocco, Salini, Vincenzo, Voglino, Nicola, Fortina, Mattia, Carta, Serafino, Sadile, Francesco, Costantino, Cosimo |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
business.industry Visual analogue scale Hyaluronic acid Sodium hyaluronate Osteoarthritis medicine.disease Rheumatology Treatment chemistry.chemical_compound Sodium chondroitin Tolerability chemistry Anesthesia Internal medicine Orthopedic surgery medicine Immunology and Allergy Chondroitin Hip osteoarthritis Intra-articular Adverse effect business Original Research |
| Zdroj: | Rheumatology and Therapy |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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