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Minerva Ortopedica e Traumatologica 2020 June;71(2):45-55

DOI: 10.23736/S0394-3410.20.03967-3

Copyright © 2020 EDIZIONI MINERVA MEDICA

lingua: Inglese

Dose-response of hyaluronate-based viscoelastic hydrogels for the treatment of knee osteoarthrosis: a prospective, randomized, comparative clinical trial

Karel PAVELKA 1, Andrea BERNETTI 2 , Nicola GIORDAN 3, Eva DOKOUPILOVÁ 4, Valter SANTILLI 2

1 Institute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic; 2 Department of Physical Medicine and Rehabilitation, Sapienza University, Rome, Italy; 3 Clinical Research Department, Fidia Farmaceutici, Abano Terme, Italy; 4 Medical Plus Rheumatology and Osteology Center, Uherské Hradiště, Czech Republic



BACKGROUND: A hyaluronate formulation for viscosupplementation, Hymovis (HYADD 4) has been proposed for treating osteoarthritis (OA) through a single injection instead of two. This study aimed to compare the safety and performance of two different doses of a single Hymovis injection to those of Synvisc-One, a well-known single-injection formulation.
METHODS: Sixty OA patients were prospectively recruited and randomly assigned to a single injection of Hymovis 4 mL/32mg (N.=20, age 63±9 years) or 6 mL/48 mg (N.=22, age 67±8 years), or Synvisc-One 6 mL/48 mg (N.=20, age 64±10 years), and assessed through the Western Ontario McMaster University Osteoarthritis index (WOMAC) on a monthly basis up to 6 months.
RESULTS: Two patients treated with Synvisc-One withdrew due to injection site joint inflammation. A significant improvement in OA symptoms was observed for all study groups at all time points following injection. No significant differences were observed among the treatment groups for all the study performance and safety endpoints.
CONCLUSIONS: One injection of Hymovis 4 mL/32 mg was as safe and effective as one injection of Synvisc-One 6 mL/48 mg and should be the preferred dosage in the treatment of symptomatic knee OA by single intra-articular injection.


KEY WORDS: Knee osteoarthritis; Hyaluronic acid; Viscosupplementation

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