Risk of Revision After Hip Fracture Fixation Using DePuy Synthes Trochanteric Fixation Nail or Trochanteric Fixation Nail Advanced

Abstract

Background: Prior reports of the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) revealed a potential mode of fatigue failure at the proximal screw aperture following fixation of extracapsular hip fractures. We sought to compare the revision risk between the TFNA and its prior-generation forebear, the Trochanteric Fixation Nail (TFN).Methods: A retrospective cohort study was performed using data from a U.S. integrated health-care system's hip fracture registry. The study sample comprised patients who underwent cephalomedullary nail fixation for hip fracture with a TFN (n = 4,007) or TFNA (n = 3,972) from 2014 to 2019. We evaluated the charts and radiographs for patients who underwent any revision. Multivariable Cox regression was used to evaluate the risk of revision related to the index fracture.Results: At the 3-year follow-up, the cumulative probability of revision related to the index fracture was 1.8% for the TFN and 1.9% for the TFNA. After adjustment for covariates, no difference was observed in revision risk (hazard ratio [HR], 1.18 [95% confidence interval (CI), 0.80 to 1.75]; p = 0.40) for the TFNA compared with the TFN. The TFNA was associated with a higher risk of revision for nonunion than the TFN (HR, 1.86 [95% CI, 1.11 to 3.12]; p = 0.018). At the 3-year followup, implant breakage was 0.06% for the TFN and 0.2% for the TFNA; with regard to aperture failures related to the index fracture, there were 1 failure for the TFN group and 3 failures for the TFNA group.Conclusions: In a large cohort from a U.S. hip fracture registry, the TFNA had an overall revision rate that was similar to that of the earlier TFN, with implant breakage being a rare revision reason for both groups. Chart and radiographic review found that the TFNA was associated with a higher risk of revision for nonunion.Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence. Implant breakage remains a risk after operative fixation of extracapsular proximal femoral fractures using cephalomedullary nails and is estimated to occur in 2% to 3% of cases despite contemporary implant designs 1-3 . Although earlier modes of failure may be less common, the continued evolution and introduction of new cephalomedullary nails have the potential to yield unexpected unique failure patterns. Furthermore, in spite of advances in design, a revision surgical procedure for lateral implant prominence, implant cut-out, or nonunion remains a risk 4-6 .As with other cephalomedullary designs, the DePuy Synthes Trochanteric Fixation Nail (TFN) has been associated with revision for blade or screw cut-out in the head, although these observations were only described in single-center series [4][5][6][7][8] . With multiple design changes to better accommodate the osseous anatomy of the proximal part of the femur, the Synthes Trochanteric Fixation Nail Advanced (TFNA) was introduced in 2014 as a successor to the TFN 9 . The specific modifications to the TFNA included a reduction of the proximal dia...

Demographic and clinical profile of patients treated with proximal femoral nails – a 10-year analysis of more than 40,000 Cases

“…This finding is in line with other papers that reported approximately 5% reoperations after IM nail use [16]. Goodnough et al reported a 1.8-1.9% revision rate, but the definition of revision in this paper was limited to operations "in which a component was removed and/or replaced" [9]. Our definition was broader and included any reoperation of the hip.…”

“…This device is different from other marketed nails as it was designed with a smaller proximal diameter -to allow greater preservation of native bone-but also a far stronger material, to reduce risk of breakage. As expected, a recent study looking at rate of nail breakage from TFNA vs that of other devices revealed no difference, and a 7,979 patients study from the Kaiser healthcare system further confirmed this finding [8,9].…”

“…Our study was designed to understand the characteristics of patients treated with intramedullary nails, for proximal femur fracture. Recent studies have demonstrated that TFNA nails had similar revision and breakage risks, compared to other devices [8,9]. Our study was thus design to further understand the patient population, overall healthcare utilization and readmission rates, in patients treated with TFNA vs comparators.…”

Defining Cephalomedullary Nail Breakage Rates: A Systematic Review and Meta-Analysis

“…Only 2 studies accounted for censoring of patients due to death. 13,15 In contrast, the rate could potentially be lower than reported, such as if breakages were diagnosed when they did not occur (coding or documentation errors) or partial capture of patients at risk (missing patients that had the implants inserted).…”

“…[14][15][16] The fourth study detected revisions defined as any operation after index procedure in which a component was removed and/or replaced; however, it did not specify how the database was queried for that outcome. 13 Those patients then had a hospital record review.…”