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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.
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BACKGROUND: The reduced concentration of hyaluronic acid in the synovial fluid, leading to impairment of joint function and painful symptomatology during knee osteoarthritis (OA), can be restored by using injectable formulations of hyaluronic acid (HA) and chondroitin sulfate (CS), variable for relative composition, HA/CS molecular modifications, and injection protocols. The present study aims to assess the safety and performance of the intra-articular (IA) viscosupplementing agent HYALGO, a formulation combining 40 mg/mL HA (>1700 kDa) and 40 mg/mL CS, in the treatment of patients suffering from knee OA. METHODS: 74 patients affected by knee lesions classified as grade II and III according to Kellgren and Lawrence classification were prospectively recruited and treated with three HYALGO injections (2 mL) given one week apart. Visual analogue scale (VAS) pain changes were monitored at each injection and over-time at 6, 14, and 26 weeks of follow-up. Secondary endpoints were: Western Ontario McMaster University Osteoarthritis index (WOMAC), Patient's Global Assessment (PGA) score, Clinical Observer Global Assessment (COGA) score, Outcome Measures in Rheumatology Committee (OMERACT) and Osteoarthritis Research Society International (OARSI) responders rates. Patients were also assessed for changes in their ultrasound joint scores according to the criteria of the OMERACT US Task Force Group. RESULTS: Pain reduction was statistically significant starting from the first IA injection. Mean pain reduction from baseline to week 26 was -90.6%. At 26 weeks, WOMAC Pain was reduced by -62.7%, WOMAC Stiffness by -47.2%, WOMAC Physical Function by -54.1%; Total WOMAC by -53.8%. The VAS PGA change from baseline was -48.0 [mm] and VAS COGA -41.0 [mm]. Responders at week 26 were 78.4%. Ultrasound parameters (joint effusion, synovial thickness, and popliteal cysts) improved or remained stable from baseline to week 6. CONCLUSIONS: Three injections of HYALGO were safe and effective to manage symptomatic knee OA, with a beneficial effect that increased progressively over time, peaking 6 months after injection.
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INTRODUCTION: The current study compares two hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance, for the treatment of wrinkles. MATERIALS AND METHODS: This is a single-center, double-blind randomized controlled study. Inclusion criteria consisted of subjects with bilateral nasolabial wrinkles. Each subject was treated with both products: One was applied on the right side and the other on the left side of the face. The quantity of product injected and any problems or local reactions (erythema, edema, pain or itching) were recorded and reassessed at 3 and 6 months and then monthly until complete absorption of the product. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used for the assessment, as well as an ultrasound measurement of the skin thickness. RESULTS: Complete data were available for 59 subjects. At 3 and 6 months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them. No resulting significant differences were observed on skin thickness among the two products, which were completely reabsorbed in 285 ± 34 days (Ial System Duo) and 277 ± 34 days (Belotero Basic/Balance; Student's t test: p = 0.2181). No significant differences were observed with regard to the subject's satisfaction and adverse events. CONCLUSIONS: The Ial System Duo achieves long-term permanence (more than 9 months confirmed by ultrasound) in correction of moderate and severe wrinkles, similar to Belotero Basic/Balance. Both products showed a high safety profile and a high degree of subject and physician satisfaction. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .