Non-Inferiority of a Single Injection of Sodium Hyaluronate Plus Sorbitol to Hylan G-F20: A 6-Month Randomized Controlled Trial

Several viscosupplement treatments are available for patients suffering from painful osteoarthritis (OA) of the knee, but few comparative clinical trials have been conducted. The primary objective trial was to demonstrate non-inferiority Synolis VA (80 mg hyaluronic acid and 160 sorbitol) (Group HA1) Synvisc-One (48 hylan GF-20) HA2) at Day 168 in terms pain relief efficacy with knee OA (Kellgren Lawrence radiological stage II or III) whom oral treatment analgesics, NSAIDs weak opioids provided insufficient responses were poorly tolerated. This a prospective, multicentre, comparative, randomized, double-blinded comparing two previously indicated viscosupplements, HA1 HA2. average VAS score (1–100) 62.5 baseline (Day 0). randomized into parallel groups 0 followed until 168. They received one injection either end point evolution Western Ontario McMaster University (WOMAC) index D168 groups. One secondary points daily assessment this by patient 7 days following thereafter 14. other WOMAC pain, stiffness, function total scores assessed 28, 84 At 168, satisfaction evaluator using Likert scale (7 points). Moreover, number strict responders each group evaluated according Osteoarthritis Research Society International (OARSI) Standing Committee Clinical Trials Response Criteria Initiative Outcome Measures Rheumatology (OMERACT) criteria (OMERACT-OARSI). per protocol (PP) population used analysis. A 202 randomized. predominantly female (66%). median age whole 65 years, body mass 27.4 kg/m2. No statistically significant differences between observed any demographic criteria. 197 had no violations (94 103 HA2 group). decreased groups: − 29.2 ± 24.1 (SD) 31.6 25.5 group, confirming (P = 0.57 difference groups). Regarding points, 14, all outcomes except stiffness 28 favour HA2). rate comparable 79% 77% Both products well Serious adverse events reported four 3 group. In trial, we confirmed compared score. Safety satisfying 2017-A00034-49.