Figure 6.

Non inferiority or clinical equivalence.

The graph illustrates the difference between the ARTHRUM and the EQUIVALENTS groups, for each WOMAC sub-score, at all observation times. Positive results are in favour of ARTHRUM. The squares represent the mean difference (MD) – filled in red for the main criterion – and the vertical bars represent the 95% CI. The orange and green lines respectively represent the non-inferiority limit for ARTHRUM (which is always observed) and its superiority limit. When the 95% CI intervals are totally between these two limits, it is reasonable to infer clinical equivalence between ARTHRUM and EQUIVALENTS devices. But when the upper bound of the CI interval is above the green limit, one can assume a combined non-inferiority and superiority of ARTHRUM. Also, when the lower bound of CI is above zero. a statistical superiority of ARTHRUM over EQUIVALENTS is observed (p<0.05).