Retrospective cohort study analyzing outcomes of the SIGN Fin Nail in adult femoral fractures using the retrograde approach.

ABSTRACT

Purpose: There is high burden of long bone fractures in low- and middle-income countries (LMICs). Given a limited availability of fluoroscopy in LMICs, the Surgical Implant Generation Network (SIGN) developed two types of intramedullary nails the SIGN standard nail and the SIGN Fin Nail. A limited number of studies have analyzed healing outcomes with the SIGN Fin Nail and the current study is the largest one to date. The purpose of this study is to compare outcomes between the SIGN standard nail and SIGN Fin Nails in adult femoral shaft fractures treated with a retrograde approach. Method: A retrospective cohort study of adults with femoral shaft fractures was performed using the Sign Online Surgical Database (SOSD). The primary outcome was achieving full painless weight bearing and the secondary outcomes assessed were radiographic healing and infection. A propensity-score adjustment was performed for potential confounders and effect modification due to fracture location was tested using a Mantel-Haenszel test for heterogeneity. Results: Of 19,928 adults with femoral shaft fractures, 2,912 (14.7%) had the required 6-month follow-up to be included. The overall propensity score weighted relative risk between the Fin and Standard Nail for achieving painless weight-bearing was 0.99, 95% CI [0.96-1.03] and for radiographical healing was 0.99, 95%CI [0.97-1.02]. The propensity score weighted relative risk for infection was 1.30, 95% [0.85-1.97]. Use of the Fin nail was also significantly associated with shorter surgery times (p < 0.005, effect size = 24 min). Sub-group analysis based on fracture location and injury cause demonstrated no change in relative risk. Conclusion: The Fin nail showed no change in relative risk in terms of achieving full painless weightbearing or radiographic healing compared to the standard nail for retrograde nailing of femoral shaft fractures in adults. The heterogeneous nature of the cohort and large sample size allow for generalizability and add to a growing base of literature supporting use of the Fin Nail for retrograde femoral nailing. However, there are limitations as we could not correct for comminution at the fracture site or measure radiographic alignment or shortening.