Statistical analysis
EVENTS, STILL
Analysis will be conducted according to the intention-to-treat principal. The primary outcome satisfaction, a proportion, will be compared with chi-square test. For the primary outcome two-tailed tests will be applied since the null hypothesis is that there is no difference between the two reconstructive methods. Secondary outcomes assumed to be normally distributed will be compared between the two study arms using t-tests. Functional and QoL variables will be analyzed with mixed model ANOVA analysis. Time to failure will be analyzed with multivariate cox-regression analysis. Kaplan–Meier curves will be constructed and compared with log-rank tests. Repeating events, such as reoperations, will be analyzed with multivariate Poisson-regression.There is no data and safety monitoring committee since all treatment is according to established practice. We do not plan to perform any interim analysis.From a statistical point of view our choice of primary endpoint is not optimal because we have no reason to expect any difference between the two study arms. Still, to our opinion, this is the most important outcome measure.