Mechanical Failure of the Stryker T2 Alpha Retrograde Femoral Nail.

Abstract

Objective: To evaluate mechanical failure rates of retrograde femoral nails in the treatment of distal femur fractures.

Methods: Design: Retrospective chart review.

Setting: Urban Academic Level 1 Trauma Center.

Patient selection criteria: Included were adult patients who sustained a distal femur fracture (AO/OTA 33) who were treated with a retrograde intramedullary nail from August 2021 through September 2022.

Outcome measures and comparisons: The primary outcome was the rate of mechanical failure of the intramedullary nail defined as deformation and/or breakage of the intramedullary nail. The rate of mechanical failure was compared amongst retrograde femoral nails used at the same institution during the same time period.

Results: One hundred and twenty distal femur fractures were identified (77 native distal femur, 43 periprosthetic) that were treated with a retrograde intramedullary nail. Average patient age was 67 years (SD 15.1, range 18-96 years). Eighty-three (69.2%) of patients were female. Four mechanical nail failures (deformation and/or breakage of the intramedullary nail) were observed within six months of surgery, two in patients with native distal femur fractures, and two in patients with periprosthetic distal femur fractures. All failures occurred among forty-nine fractures treated with a newly released retrograde femoral nail, the T2 Alpha Retrograde Femoral Nail (Stryker, Mahwah, NJ). This represents an 8.2% mechanical failure rate of distal femur fractures treated with this new nail compared to no failures observed with any other nail (p=0.03).

Conclusions: Mechanical nail failures, within six months of surgery for distal femur fracture, of a new retrograde femoral nail were observed to be higher than seen with other nails. Further evaluation is needed to determine if this experience represents factors related to patient, injury, or surgical characteristics, an anomaly, or a safety signal.

Level of evidence: Therapeutic Level III. See instructions for authors for a complete description of levels of evidence.