To confirm the structure-modulating properties of ACS4-ACS6 in gonathrosis by measuring the modifications in minimum joint space width, the mean thickness and the mean surface of the cartilage in internal femorotibial function.
This was a double blind prospective study versus placebo including 300 symptomatic patients with internal femorotibial gonathrosis. The measurements were made with a semi-automatic method validated from digitalized radiological images taken at two years in each patient.
There was an equal number of dropouts in the 2 groups (40 in the ACS4-ACS6 group and 41 in the placebo group). After 2 years, there was a significant difference, with worsening of the affection in the placebo group. In the group treated with ACS4-ACS6, there was no significant variation in all the radiological parameters, which remained remarkably stable. When comparing the 2 groups, the statistical analysis revealed a significant difference in the ACS4-ACS6 group with maintenance of the cartilage analyzed, not only in the intent-to-treat patients but also in the per protocol population.
ACS4-ACS6 is superior to the placebo with regard to the stabilization of minimum joint space width of the internal femorotibial articular space, the mean thickness and the surface.