Safety and efficacy of a novel cephalomedullary nail femoral shaft fractures: a retrospective observational cohort in 33 patients

BACKGROUND: Despite advances in femoral shaft fracture fixation, the nonunion rate remains relatively high; and there is limited data on the efficacy and failure rate of specific implants. A novel cephalomedullary nail provides the ability to treat femur shaft fractures in isolation, with associated ipsilateral femur injuries, and provides various options for proximal and distal fixation exists on the market; but literature remains limited on the safety and efficacy of this implant. The aim of this study is to evaluate the early failure rate of this cephalomedullary nail, while comparing the nonunion rate to what is currently presented in the literature. This study is the first of its kind in evaluation of a specific implant for treatment of femoral shaft fractures and ipsilateral pathology. METHODS: Patients over 18 years of age, with traumatic femur shaft fractures, treated with this particular cephalomedullary nail and available for a minimum of 3-month follow-up were included for analysis. Data was collected by retrospective chart review and review of existing radiographs. Demographic data, injury details, AO/OTA fracture classification, and implant details were recorded for each patient. Primary outcome measured was implant failures (screw or nail breakage). Secondary outcomes measured included malunion, nonunion, deep infection, post-operative complications, and need for reoperation. RESULTS: Of the 33 patients included for analysis, 1 patient went on to non-union. There were no cases of implant failure. The single nonunion was a high-energy mechanism, open fracture, and higher level AO/OTA classification. The remaining 32 reached radiographic union at 3 months. CONCLUSION: The nonunion rate of this novel cephalomedullary nail is comparable to what is reported in the literature. This nail is a safe and effective implant to treat femoral shaft fractures with a variety of ipsilateral femoral shaft injuries and reliably leads fracture union. Further studies are needed analyzing implant failure and comparing specific implants.