New Viscoelastic Hydrogel Hymovis MO.RE. Single Intra-articular Injection for the Treatment of Knee Osteoarthritis in Sportsmen: Safety and Efficacy Study Results.

Andrea Bernetti,Francesco Agostini,Federica Alviti,Marco Paoloni,Federica Martella,Valter Santilli,Nicola Giordan,Massimiliano Mangone

doi:10.3389/fphar.2021.673988

Abstract

Viscosupplementation by hyaluronic acid (HA) is recommended for non-surgical management of knee osteoarthritis (OA). This study investigated the efficacy and safety of a single i.a. (32 mg/4 ml) Hymovis MO.RE. injection, a new HA derivative hydrogel, for the treatment of adult regular sports players affected by knee OA arising from overuse injuries. Patients were prospectively enrolled if regularly practicing sports and diagnosed with Kellgren-Lawrence grade I-III OA. They received a single Hymovis MO.RE. intra-articular (i.a.) injection and were evaluated 30, 90, 180, and 360 days thereafter. The assessment involved measuring changes in knee function, pain, the activity of daily living (ADL), and quality of life (QOL) by using the Knee injury and Osteoarthritis Outcome Score (KOOS), GAIT analysis, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for knee pain (WOMAC A) and function (WOMAC C), and a visual analogue scale (VAS) pain score. The study involved thirty-one patients, 23 women and eight men, whose median age was 49. KOOS function subscore, as well as GAIT cadence and velocity, showed a statistically significant increase at each time-point after injection (p < 0.0001). WOMAC, KOOS pain, symptoms, ADL, and QOL scores also significantly improved at all control visits. No severe adverse events or treatment-related events were detected. A single Hymovis MO.RE. (32 mg/4 ml) intra-articular injection provides a rapid, lasting, and safe response in regular sports players affected by knee OA, possibly representing a viable therapeutic option for this demanding patient subgroup. Further investigations are necessary to confirm these findings.

Highlights

Frequent or intense stress can cause cartilage wear and inflammation, resulting in overuse injuries (Aicale et al, 2018)
The main clinical improvement consisted in a significant increase of knee function, as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) scores, starting at day 30 and lasting over one year from treatment, according to a pattern confirmed by similar changes of the WOMAC-C score over time
The robustness of these findings is enhanced by the results of concomitant GAIT evaluations, which were consistent as they exhibited the same variation pattern of the KOOS function and WOMAC-C subjective scores: mean cadence and velocity significantly increased from the first follow-up visit

Summary

Introduction

Frequent or intense stress can cause cartilage wear and inflammation, resulting in overuse injuries (Aicale et al, 2018). These are widespread in active people and athletes, accounting for 30% of all injuries related to sports activities (Taunton et al, 2003; Yang et al, 2012; Bernetti et al, 2014). The incidence of these injuries peaks in people younger than 30 (Majewski et al, 2006). An evaluation of osteoarthritis in the early stage is essential to evaluate the most suitable treatment (Iolascon et al, 2017; Luyten et al, 2018; de Sire et al, 2020; de Sire et al, 2021)

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