Fig 1.
FAS = Full Analysis Set; ITT = Intention-to-Treat; n = number of patients; PP = Per Protocol.
Table 1.
Patient demographics and baseline characteristics (Intention-to-Treat population).
Fig 2.
Evolution of the WOMAC pain subscale during the 6-month trial.
The two graphs represent data of the Per Protocol dataset (a) and Full Analysis Set (b). They are presented as means of observed cases ± standard deviation. Sodium hyaluronate group: saltire with dashed line; control group: hollow circle with dotted line; n = number of patients; WOMAC A = Western Ontario and McMaster Universities Osteoarthritis Index pain subscale.
Table 2.
Primary and secondary efficacy criteria at 6 months post injection (Per Protocol dataset).
Fig 3.
Non-inferiority of sodium hyaluronate vs hylan G-F 20 in the Per Protocol dataset and Full Analysis Set.
Point estimates and 95% confidence interval of the intergroup difference in the primary efficacy endpoint (change from baseline in WOMAC A at 6 months). FAS = Full Analysis Set; PP = Per Protocol dataset; WOMAC A = Western Ontario and McMaster Universities Osteoarthritis Index pain subscale.
Fig 4.
Evolution of the secondary efficacy criteria during the 6-month trial (Per Protocol dataset).
The four graphs represent WOMAC stiffness subscale (a), WOMAC function subscale (b), Lequesne index (c) and patient global assessment of disease activity (d). Data are presented as means of observed cases ± standard deviation. Sodium hyaluronate: saltire with dashed line; control group: hollow circle with dotted line; PtGA = patient global assessment of disease activity; WOMAC B, C = Western Ontario and McMaster Universities Osteoarthritis Index stiffness, function subscales.
Table 3.
Safety outcomes in the patients who received an injection of the investigational product.
Table 4.
Summary of changes from baseline in pain at 6 months post treatment in previous published studies.