CLINICAL PERFORMANCE

CLINICAL EVIDENCE
SYNOLIS VA®

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Synolis VA® clinical performance on pain and safety at 6 months

This clinical trial has demonstrated an efficacy equivalence between Synolis VA® and Synvisc One® on symptoms of knee OA (osteoarthritis) at 6 months.

CLINICAL STUDY DESIGN

  • Prospective, multicenter, phase IIIb, comparative, randomized, double-blinded study.
  • 201 women and men aged 40 to 85 years, with Kellgren-Lawrence grade II to III uni- or bilateral tibiofemoral OA according to the ACR (American College of Rheumatology) criteria, and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain on VAS (Visual Analogue Scale) of at least 40 mm.
  • Endpoints measured at days: 28, 84 and 168.
  • The primary endpoint was the change from baseline in WOMAC Pain at Day 168. The lower margin of non-inferiority was pre-specified at -8 mm. The per-protocol population (PP) set was used for the principal analysis.

CONTINUOUS PAIN REDUCTION

Equivalent efficacy to SYNVISC ONE after 6 months.

SYNOLIS VA® has a 61.8% of WOMAC pain decrease compared to baseline at 6 months.1

WOMAC PAIN GRAPH

A SIGNIFICANT PAIN REDUCTION FOR PATIENTS

After 1 week, A significant and fast pain relief 1

There is a pain reduction for patients having a severe VAS pain at baseline.
Graph WOMAC PAIN ITT

REDUCTION OF CO-MEDICATION

The SYNOLIS VA® injection allowed to a significant number of patients to stop co-medication.

Stopping co-medication suggest a positive cost-benefit outcome.

1

A POWERFUL IMPACT

SYNOLIS VA® has a powerful impact on knee OA symptoms

From the 1st to the 6th month the pain reduction was improved of 16.7% in parallel of stiffness and joint impairement improvements which allow the patient to have a better quality of life. 1

Graph WOMAC TOTAL

CONCLUSION

Over the 6 months study period, Synolis VA® was equivalent to the most prescribed and studied device (Synvisc One®), while it demonstrated a significant and fast pain relief with 41% WOMAC pain decrease at day 7, and allowed a significant number of patients to reduce co-medication, suggesting a positive cost-benefit outcome. 1

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Download the poster by clicking on the picture.

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