2 results
Approved WMOPending
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
Approved WMORecruiting
Primary goal: mean linear wear of the cross-linked polyethylene F.A.L. cup compared to the mean linear wear of the standard polyethylene F.A.L. cup at 5 years postoperatively. Secondary goals:1. mean linear wear (millimeters/year) at 1 year, 3 years…