股骨近端抗旋转髓内钉内固定治疗股骨转子间骨折的安全性和有效性:前瞻性病例系列临床试验方案

Safety and effectiveness of proximal femoral nail antirotation for the treatment of intertrochanteric femoral fracture: study protocol for a prospective case series

背景:老年股骨转子间骨折的根本原因是骨质疏松,表现为骨质量的减退和骨强度的降低,使内固定器与骨之间的锚合力降低,也是内固定失效导致手术失败的主要原因。股骨近端特殊解剖结构和生物力学要求内固定必须具备抗内翻应力和防止近端骨折块旋转应力两种基本功能,减少髋内翻的发生是治疗目的之一。目的:客观验证微创股骨近端防旋型髓内钉治疗长管状骨骨折的有效性与安全性。方法:研究为单中心、前瞻性、前后对照、病例系列研究,目的在于验证微创股骨近端防旋型髓内钉治疗长管状骨骨折的有效性与安全性,试验在中国安徽,安徽医科大学附属巢湖医院骨科完成;纳入研究为诊断明确的股骨转子间骨折患者20例,给予股骨近端抗旋转髓内钉内固定治疗。研究方案取得中国安徽医科大学附属巢湖医院伦理委员会的书面批准,且符合世界医学会制订的《赫尔辛基宣言》,且已在ClinicalT rials.gov注册(NCT02880501)。患者对试验内容知情同意。结果与结论:试验的主要结局为股骨近端防旋型髓内钉植入后3和6个月出现植入相关安全性问题患者的百分率,表现为患部疼痛、伤口不愈合、切口感染、取钉时大体观察到内固定物周围软组织有炎症反应、组织增生及出现纤维囊壁等情况;次要结局为植入后3和6个月X射线平片检查评估骨折愈合情况、Harris髋关节评分评估髋关节功能,手术中情况包括手术时间、术中出血量、术中透视次数,欧洲五维健康量表评价患者的生活质量,Barthel指数评估患者的日常生活活动能力。目前关于防旋型髓内钉内固定治疗股骨转子间骨折的临床研究类型主要是回顾性系列病例研究,也可见部分回顾性随机对照试验,这些并非此类疾病临床研究的主流。此次拟开展前瞻性系列病例研究,以规范化的前瞻性设计,验证防旋型髓内钉内固定治疗股骨转子间骨折的安全性和有效性。

BACKGROUND： The root cause of intertrochanteric femoral fracture in elderly patients is osteoporosis manifested by reduced bone strength, decreased bone mineral density, and subsequently decreased anchoring between the internal fixator and bone. This is also a major cause of ineffective internal fixation and leads to surgical failure. Because of the special anatomical structure and biomechanical requirements of the proximal femur, internal fixation must have two basic functions, to prevent inversion and rotation of the proximal fractured femur. Reducing the incidence of coxa vara is also one of the treatment objectives. OBJECTIVE： To validate the safety and effectiveness of minimally invasive proximal femoral nail antirotation （PFNA） in the treatment of intertrochanteric femoral fracture. METHODS： This is a single-center, prospective, self-controlled case series. The objective of this study is to validate the safety and effectiveness of minimally invasive PFNA in the treatment of intertrochanteric femoral fracture. Twenty patients with intertrochanteric femoral fracture scheduled to undergo PFNA implantation will be recruited from the Department of Orthopedics, Chaohu Hospital of Anhui Medical University in China. The study protocol has been approved by the Ethics Committee of Chaohu Hospital of Anhui Medical University, China and will be performed in accordance with the guidelines of the Declaration of I-lelsinki, formulated by the World Medical Association. All patients will provide the written informed consent. This trial was registered at ClinicalTrials.gov （NCT02880501）. RESULTS AND CONCLUSION： The primary outcome measure of this study is the percentage of patients having PFNA implantation-related safety problems manifested as pain in the affected region, wound nonunion, incisional infection, and gross findings observed at the time of nail removal, including inflammatory reaction, tissue proliferation, and the appearance of a fibrous capsule wall 3 and 6 months after PFNA implantation. The secondary outcome measures are operative time, intraoperative blood loss, duration of intraoperative fluoroscopy, patients＇ quality of life evaluated by the EuroQol five-dimension questionnaire and the Barthel Index of Activities of Daily Living, fracture healing examined by X-ray images, and hip joint function evaluated by Harris hip scores 3 and 6 months after PFNA implantation. The currently reported clinical studies on PFNA for the treatment of intertrochanteric femoral fracture are mainly case series, a few of which are retrospective, randomized, controlled trials. Here, we will perform a normalized prospective case series to validate the safety and effectiveness of PFNA in the treatment of intertrechanteric femoral fracture.