Secondary endpoints
fracture
ADVERSE EVENTS, SECONDARY
Secondary endpoints included (a) clinical outcomes: SF-12, Harris Hip Score, and EQ-5D, (b) adverse events (type and frequency) compared between investigational and control groups, (c) 24-weeks revision rate (removal of any component for any reason), and (d) 24-weeks reoperation rate (secondary surgery at the fracture site[s] performed for any reason). In addition, assessments were collected on the surgeon’s evaluation of product operability during the index procedure.SF-12 scores were summarized for both treatment groups at baseline, and at the 12- and 24-weeks follow-up visits. In addition, SF-12 scores were summarized for change from baseline. An ANCOVA model was used with the change from baseline as the outcome variable. The treatment group was an independent variable, and the baseline value was the concomitant variable. The Harris Hip Score was only collected at the 12- and 24-weeks follow-up visits. The 12- and 24-weeks scores were summarized and compared between groups using the t test. Qualitative outcomes were compared between groups using either a Chi-square test or Fisher’s exact probability test. The EQ-5D Health Index (HI) was based upon Japanese population coefficients.