Early Complications of a Novel Retrograde Intramedullary Femoral Nail in the Treatment of Femur Fractures.

Objectives: To determine the early implant failure rate of a novel retrograde intramedullary femoral nail.

Methods:

Design: Retrospective cohort study.

Setting: Academic level 1 trauma center.

Patients selection criteria: Patients aged 18 years and older with an acute OTA/AO 32-A, 32-B, 32-C, and 33-A fractures or periprosthetic distal femur fracture from April 2018 to April 2022 were included in the study. The 2 interventions compared were the Synthes Expert retrograde/antegrade femoral nail (or control implant) versus the next-generation retrograde femoral nail (RFN)-advanced retrograde femoral nail (RFNA or experimental implant) (Synthes, West Chester, PA).

Outcome measures and comparisons: Early implant-related complications between the experimental and control implants were assessed including locking screw back out, screw breakage, intramedullary nail failure, need for secondary surgery, and loss of fracture reduction.

Results: Three hundred fourteen patients were identified with a mean age of 31.0 years, and 62.4% of the patients being male. Open fractures occurred in 32.5% of patients with 3.8% of injuries being distal femur periprosthetic fractures. Fifty-six patients were in the experimental group and 258 patients in the control group. Mean follow-up was 46.8 weeks for the control cohort and 21.0 weeks for the experimental cohort. Distal interlocking screw back out occurred in 23.2% (13 of 56) of the experimental group patients and 1.9% (5 of 258) of the control group patients ( P < 0.0001). Initial diagnosis of interlocking screw back out occurred at an average of 3.2 weeks postoperatively (range, 2-12 weeks). Fifty-four percent of patients who sustained screw back out underwent a secondary operation to remove the symptomatic screws (12.5% of all patients treated with the experimental implant required an unplanned secondary operation due to screw back out). A logistic regression model was used to predict screw back out and found the experimental implant group was 4.3 times as likely to experience distal locking screw back out compared with the control group ( P = 0.01).

Conclusions: The retrograde femoral nail-advanced implant was associated with a significantly higher rate of screw back out with a substantial number of unplanned secondary surgeries compared with the previous generation of this implant.

Level of evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.