No abstract

Introduction: Pertrochanteric fractures (PFs) frequently affect the lower limb of osteoporotic patients and represent an important cause of morbidity and mortality in the elderly. In this prospective randomized controlled trial, we have compared functional and radiological results and complications of patients affected by PFs treated with two intramedullary proximal femoral nails. Materials: We enrolled 323 subjects with PFs, classified according to AO/OTA system as 31.A1 (pertrochanteric simple) and 31.A2 (pertrochanteric multifragmentary). Patients were divided into two groups according to the osteosynthesis devices: group A, Elos-Intrauma® nail (155 cases) and group B, Gamma 3-Stryker® nail (168 cases). Pre-operatively, the baseline characteristics of each patient (gender, age, weight and BMI) were collected. Intraoperative blood loss, subjective pain by visual analogue scale (VAS), esthetic satisfaction, functional scores of the hip by Harris Hip Score (HHS), and Western Ontario and McMaster Universities Arthritis Index (WOMAC) were noted. The post-operative degree of fracture reduction was assessed. Each patient had a minimum follow-up of 12 months. Results: The study group was composed of 106 male and 217 female with an average age of 85.4 (range, 65-90, standard deviation (SD) 5.95) years. No statistical differences about sex and age distribution were noted between the two groups. Group A reported lower intraoperative blood loss, 45 ml vs 51 ml, respectively (p < 0.001). There was not any statistical difference about operative time. Group A had a better reduction of fracture (p = 0.0347). The greatest difference was detectable comparing subgroups 31.A2 (p = 0.032). There were no statistical differences about complication frequency and the overall rate was 25% (80 cases). Finally, there was no difference in terms of VAS, HHS, and WOMAC score between the two groups on each follow-up. Patients of group A showed a higher subjective satisfaction index at 1 post-operative year, 7.42 (SD 1.19) vs 6.45 (SD 1.35) of group B (p < 0.001). Conclusion: Elos® nail is a reliable device on a short-term follow-up and represents an alternative choice to the Gamma 3® nail, a well-known and appreciated system for over 25 years.