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.
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.
A POWERFUL IMPACT
SYNOLIS VA® has a powerful impact on knee OA symptoms
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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