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.

中文翻译：

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股骨近端股骨粗隆间骨折的髓内钉固定：连续323例患者接受了两种装置的治疗。

简介转子粗隆骨折（PFs）经常影响骨质疏松患者的下肢，并且是老年人发病和死亡的重要原因。在这项前瞻性随机对照试验中，我们比较了用两个髓内近端股骨钉治疗的PF影响的患者的功能和影像学结果以及并发症。材料我们招募了323名患有PF的受试者，根据AO / OTA系统将其分为31.A1（股骨粗隆）和31.A2（股骨粗隆）。根据骨合成装置将患者分为两组：A组，Elos-Intrauma®指甲（155例）和B组，Gamma3-Stryker®指甲（168例）。术前，收集每位患者的基线特征（性别，年龄，体重和BMI）。术中失血，注意到视觉模拟量表（VAS）的主观疼痛，审美满意度，哈里斯臀部评分（HHS），髋关节功能评分以及西安大略省和麦克马斯特大学关节炎指数（WOMAC）。评估术后骨折复位程度。每位患者至少随访12个月。结果研究组由106名男性和217名女性组成，平均年龄为85.4岁（范围：65-90，标准差（SD）为5.95）。两组之间没有性别和年龄分布的统计学差异。A组报告的术中出血量更低，分别为45 ml和51 ml（p <0.001）。手术时间无统计学差异。A组的骨折复位效果更好（p = 0.0347）。最大的差异是可比较的亚组31.A2（p = 0.032）。并发症发生频率无统计学差异，总发生率为25％（80例）。最后，在每次随访中两组之间在VAS，HHS和WOMAC评分方面没有差异。术后1年，A组患者的主观满意度指数较高，B组为7.42（SD 1.19），而B组为6.45（SD 1.35）（p <0.001）。结论Elos®指甲在短期随访中是一种可靠的装置，是Gamma3®指甲的替代选择，Gamma3®指甲已有25年的历史，该系统广受好评。术后1年，A组患者的主观满意度指数较高，B组为7.42（SD 1.19），而B组为6.45（SD 1.35）（p <0.001）。结论Elos®指甲在短期随访中是一种可靠的装置，是Gamma3®指甲的替代选择，Gamma3®指甲已有25年的历史，该系统广受好评。术后1年，A组患者的主观满意度指数较高，B组为7.42（SD 1.19），而B组为6.45（SD 1.35）（p <0.001）。结论Elos®指甲在短期随访中是一种可靠的装置，是Gamma3®指甲的替代选择，Gamma3®指甲已有25年的历史，该系统广受好评。