Eligibility
One hundred ninety-two patients were screened, and 188 patients were included and randomly assigned to a group; enrolment included 94 in the investigational group and 94 in the control group. Three patients were not implanted with a device, resulting in 185 patients in the FAS. Accounting for drop-outs, there were 164 patients in the PPS, including 81 in the TFNA group and 83 in the PFNA-II group. Reasons for exclusion prior to final assignments to the FAS and PPS groups are shown in Fig. 