How comparable is so-called standard fracture fixation with an identical implant? A prospective experience with the antegrade femoral nail in South Africa and Europe.

摘要

BACKGROUND: The utilisation and consequences of standardised operative procedures may importantly differ between different healthcare systems. This is the first investigation comparing the treatment and outcome of femoral shaft fractures stabilised with an identical implant between trauma centres in 2 continents (Europe, EU and South Africa, SA). METHODS: Following standardised introduction of the technique, the prospective, observational multicentre study enrolled 175 patients who underwent intramedullary fracture fixation using the antegrade femoral nail (AFN) for femoral shaft fractures. Eleven EU hospitals recruited 86 patients and 1 SA centre 89 patients in the study period. Comparison of epidemiologic data, operative characteristics as well as subjective (e.g., pain, SF-36) and objective (e.g., X-ray, range of motion [ROM]) 3-month and 1-year outcomes were performed (p<0.05). RESULTS: Compared to EU centres, several significant differences were observed in SA: (1) on average, patients operated on were younger, had less concomitant diseases and had more severe open fractures; (2) operative stabilisation was more often undertaken by young, unsupervised residents, with shorter operating and intraoperative fluoroscopy times; (3) mean hospital stay was shorter, with less recorded complications, but a higher loss to follow-up rate. Non- or malunion rates and subjective outcomes were similar for both groups, with the physical component of the SF-36 at the 1-year follow-up not fully restoring to baseline values. CONCLUSIONS: Our investigation demonstrates the importance of several major differences between 2 different regions of the world in the treatment of femoral shaft fractures, despite involving only high level trauma centres and using an identical implant. The intercontinental comparison of results from clinical studies should be interpreted very carefully considering the heterogeneity of populations and clinical settings.