Evaluation of safety and efficacy of Hylan G-F 20 (Synvisc-One®) in patients with knee osteoarthritis in clinical practice

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Combined therapy of osteoarthritis (OA) includes intra-articular injections of hyaluronic acid. A prospective observational multicenter noncomparative study was conducted in compliance with routine clinical practice in patients with knee OA I–III stages in order to assess 1-year long-term safety and efficacy of Hylan G-F 20 (Synvisc-One®, one injection of 6 mL). Patients came for observation at 3, 6, and 12 months after intra-articular injection of Hylan G-F 20. The primary objective of the study was evaluation of pain severity while walking and rest by using the WOMAC VA3.1 (Western Ontario and McMaster Universities Osteoarthritis Index) scale after 26 and 52 weeks compared to baseline. Quality of life was measured by EQ-5D (EuroQuality of Life—five dimensions); patient’s general condition was measured by PTGA (Patient Global Assessment) and COGA (Clinical Observer Global Assessment). Results of the study were based on data of 121 patients (79.51% — women, 21.49% — men), mean age 62.97 ± 12.47 years. Positive clinical response was observed in 12 months (52 weeks) after Hylan GF-20 administration: pain severity versus baseline was decreased by 48.92% (p < 0.001) as per WOMAC A, stiffness in the joints versus baseline by 49.72% (p < 0.001) as per WOMAC B, difficulties in the daily life versus baseline by 41.54% (p < 0.001) as per WOMAC C. Seven adverse events were detected in five patients (4%), and one serious adverse event (cardiovascular abnormalities) was noticed during the entire study that was unrelated to the study drug. The extent of clinical response did not correlate with the stage of osteoarthritis. The quality of life was improved by 35.28% (p < 0.001) according to the questionnaire EQ-5D. The general condition of the patients was improved by 37.50% (p < 0.001) as per COGA and 42,86% (p < 0.001) as per PTGA. No patients were discontinued the study due to adverse event or any other reasons. Intra-articular injections of Hylan G-F 20 6 mL were associated with acceptable safety and efficacy, and the therapeutic effect was observed up to 52 weeks.

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About the authors

Gennadiy V. Kuropatkin

Samara Hospital “Mother and Child – IDK”

Email: kuropatkin.gennady@gmail.com

Russian Federation, Samara

MD, Head of the Orthopedics Department

Ildar F. Ahtyamov

Kazan State Medical University

Author for correspondence.
Email: yalta60@mail.ru

Russian Federation, Kazan

MD, PhD, professor, Head of the Department of Traumatology, Orthopedics and Surgery of Extreme Conditions

Marina L. Stanislav

V.A. Nasonov Research Institute of Rheumatology

Email: marista@bk.ru

Russian Federation, Moscow

MD, PhD, Leading researcher

Vladimir A. Kushnir

Polyclinics No.3 of General Management Department of the President of the Russian Federation

Email: Drkushnir01@gmail.com

Russian Federation, Moscow


Igor G. Belenkiy

Pavlov University; Alexander Hospital

Email: Belenkiy.trauma@mail.ru

Russian Federation, Saint Petersburg

MD, PhD, Professor of the Department of Traumatology and Orthopedics; Head of the Department of Traumatology No.1 

Sergey S. Kopenkin

Pirogov Medical University

Email: Serko2001@mail.ru

Russian Federation, Moscow

MD, associate professor of the Department of Traumatology and Orthopedics and Military Surgery

Vartan O. Tamazyan

Central City Clinical Hospital

Email: vartantamazyan@yandex.ru

Russian Federation, Reutov


Natalya N. Vezikova

Petrozavodsk State Medical University

Email: Vezikov23@mail.ru

Russian Federation, Petrozavodsk

MD, PhD, Professor, Head of the Department of Hospital Therapy

Vasiliy V. Klyuchevskiy

Yaroslavl State Medical University

Email: Kluchevsky@inbox.ru

Russian Federation, Yaroslavl

MD, associate professor of the Department of Traumatology and Orthopedics


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Supplementary files

Supplementary Files Action
Fig. 1. Dynamics of pain at rest and walking (WOMAC VA3.1 section A). 1 — pain when walking, 2 — pain at rest

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Fig. 2. Assessment of therapy efficacy by patient and doctor (visual analogue scale). 1 — patient, 2 — doctor

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Copyright (c) 2020 Kuropatkin G.V., Ahtyamov I.F., Stanislav M.L., Kushnir V.A., Belenkiy I.G., Kopenkin S.S., Tamazyan V.O., Vezikova N.N., Klyuchevskiy V.V.

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