Discussion
factures or subtrochanteric fractures, blood loss, fracture, femur fractures, fractures
BLOOD LOSS, SECONDARY, ADVERSE EVENTS, POSTOPERATIVE COMPLICATIONS
In terms of the primary outcome, it was found that the healing rate based on the collected patient data (non-missing data) was 100% in both the TFNA group and the PFNA-II group. We believe that our high degree of fracture union was at least partly attributable to the stringent exclusion criteria shown in Table Regarding secondary outcomes, information was collected for the revision and reoperation rates at 24 weeks after surgery, as well as the SF-12, Harris Hip, and EQ-5D Scores. There were not revisions or reoperations in either group. Clinical outcome scores were statistically indistinguishable, indicating no signification differences between either implant. In addition to these clinical outcomes, the apparent equivalence of surgical markers such as blood loss and surgery time supported the non-inferiority of the TFNA compared to the PFNA-II.During the study, all intra- and post-operative AEs were recorded and evaluated for relationship to the device or procedure. With a total of 18 and 16 SAEs occurring in the TFNA and PFNA-II groups, respectively, it was shown that the safety profile of TFNA demonstrated no significant difference from the PFNA-II. No device-related adverse events were identified in the clinical study.Regarding the operability of both the TFNA and PFNA-II devices, surgeons’ assessments of the two products across various stages of handling were found to be virtually identical. Because differences in healing rates and Harris scores and safety between blades and screws were found to be insignificant, the selection of blades or screws depended upon the preference of surgeons. The static locking option was not collected because the surgeons only used that option when the AO classification of the fracture was A3 or if there were other unstable fractures, less than 10% of the patients studied (Table The average age of our patients was 77.8 years for the TFNA group and 74.1 years for the PFNA-II group, in excellent agreement with the average age of 77.1 of the 190,560 patients confirmed as having various classes of hip fracture obtained from the Urban Employee Basic Medical Insurance and Urban Resident Basic Medical Insurance databases, covering over 95% of the whole urban population of China [In agreement with our findings, Yoon et al. reported an excellent outcome for the TFNA concerning safety and the surgical treatment of proximal femur fractures in Korea. Specifically, 100% bone union was observed with no early postoperative complications, no implant failures, and no cases of revision surgery [Compared to outcome measures of the PFNA-II, PFNA, InterTAN, and Gamma intramedullary nails, the performance of the TFNA in several parameters appears to be equivalent to several values reported in the literature. Table Performance comparisons of TFNA, PFNA, PFNA-II, InterTan, and Gamma Intramedullary nails in the treatment of intertrochanteric fractures of the proximal femurBold numbers are the outcomes from the current studyAbbreviations: The absence of implant breakages in our findings may be related to the paucity of type A3 fractures included in our study groups. In contrast with our prospective study, Lambers et al. [Further support regarding the safety of the TFNA device was obtained through a study of retrieved data from a large US healthcare database containing inpatient discharges from geographically diverse hospitals in both urban and rural areas. Since 2012, the database has received contributions of data from over 700 hospitals. The study compared data from the TFNA to a comparison group, which included the Stryker Gamma3 and Zimmer Natural Nail (non-TFNA group). During the study period, implantations with 14,370 TFNA nails were identified and compared with implantations of 8260 non-TFNA nails. When the risk data were balanced, the risk of breakage in 18 months was equivalent in subgroup analyses involving pertrochanteric factures or subtrochanteric fractures [This was the first randomized controlled trial demonstrating the noninferiority of fracture union rates for the TFNA system to an established device in China. The noninferiority approach to benchmarking offers an immediate comparison of implanted devices using a reference standard, featuring advantages compared to standard Kaplan–Meier analyses [