Primary endpoint
31-A1, fracture, OA, 31-A2 and 31-A3
The primary endpoint was fracture union at 24 weeks postoperatively. In the FAS, there were a total of 93 patients in the TFNA group, of which 11 (11.8%) did not have an assessment for the measurement of fracture union at 24 weeks after surgery; there were a total of 92 patients in the PFNA-II group, of which 7 (7.6%) did not have an assessment for the measurement of fracture union at 24 weeks after surgery.Based on analysis of the actual data collected from patients (non-missing data), all 82 patients in the TFNA group had fracture union, and all 85 patients in the PFNA-II group had fracture union, resulting in a fracture union rate of 100% at 24 weeks after surgery in both groups. When the Newcombe–Wilson scoring method was used, the fracture union rate difference between the TFNA group and the PFNA-II group was 0. The two-sided 95% CI [− 4.48%; 4.32%] was within the 10% threshold of non-inferiority, indicating that the TFNA group was not inferior to the PFNA-II group.Examples of each of the fracture classes and implantations of the TFNA and PFNA-II devices with comparable union are shown in Fig. Examples of X-ray images pre-op and 24 weeks post-op for 3 OA classifications (31-A1, 31-A2 and 31-A3) in 2 groups. Abbreviations: 