Strengths and limitations
COMPLICATIONS
In this study, we enrolled 105 patients. The drop-out rate at 12 months was 18% (19) and 23% (24) at 24 months. This was a higher rate than we expected, and the number of patients in the FC group was therefore lower than expected in the power analysis. However, the drop-out rate did not exceed 30% for long-term follow-up and we may conclude that the risk of bias has not increased. The sample size we used does not, however, permit convincing conclusions for infrequent outcomes, such as the difference in the rate of complications between the two studied interventions, to be made. Additionally, the SD of our primary outcome, PRWE score at 24 months, was larger than anticipated and utilized in a priori power calculation. However, the functional results remained consistent regardless of this.