Fixation using Alternative Implants for the Treatment of Hip Fractures: A Multi-c

描述(由申请人提供)： 项目摘要每年有28万美国人(每周超过5000人)和3.6万加拿大人(每周超过690人)发生髋部骨折。髋部骨折与一年内30%的死亡率和严重的暂时性、有时是永久性的独立性和生活质量损害有关。全世界每年有450万人因髋部骨折而致残，预计未来40年将增加到2100万人。髋部骨折的住院天数比任何其他肌肉骨骼损伤都要多，占因骨折而住院的总天数的三分之二以上。在全球所有致残原因中，髋部骨折造成的伤残调整寿命损失年数排在前10位。确定最佳内固定方法可能会改善数以万计的患者的生活。我们的主要目标是评估滑动髋部螺钉固定与中空螺钉固定对股骨颈骨折患者2年内翻修手术率的影响。我们的次要目标是确定LIKE(缩写形式-12，SF-12)、功能结果(西部安大略省麦克马斯特骨关节炎指数，WOMAC)和健康效用(Euro-QOL-5D，EQ-5D)对健康相关质量的影响。我们提出了一个多中心，隐蔽的随机试验设计，使用最小化来确定患者分配。外科医生将使用两种手术策略中的一种来治疗股骨颈骨折。第一种方法包括用多个小直径松质骨螺钉(即松质骨钉组)固定骨折。第二种治疗策略包括用带侧板的单个大直径螺钉(即滑动髋部螺丝钉组)固定骨折。研究人员将监测围术期护理和康复的关键方面，以发现方案偏差。我们将在患者出院时、术后2周、10周、3个月、6个月、9个月、12个月、18个月和24个月对患者进行评估。主要结果是在初次手术后2年内进行翻修手术。次要结果包括患者的生活质量(简明表格-12，SF-12)、功能(西安大略省麦克马斯特骨关节炎指数，WOMAC)和健康效用(EuroQol-5D，EQ-5D)。我们将定期独立裁决翻修手术率，最长可达2年。这项试验不仅将改变目前的整形外科实践，而且将为未来整形外科试验的进行设定一个基准。

DESCRIPTION (provided by applicant): Project Summary Hip fractures occur in 280,000 Americans (over 5,000 per week) and 36,000 Canadians (over 690 per week) annually. Hip fractures are associated with a 30% mortality rate at 1 year and profound temporary, and sometimes permanent, impairment of independence and quality of life. Worldwide, 4.5 million persons are disabled from hip fractures yearly with an expected increase to 21 million persons living with disability in the next 40 years. Hip fractures account for more hospital days than any other musculoskeletal injury and represent more than two thirds of all hospital days due to fractures. The disability adjusted life-years lost as a result of hip fractures ranks in the top 10 of all cause disability globally. Identifying the optimal approach to internal fixation is likely to improve the lives of tens of thousands of patients. Our primary objective is to assess the impact of sliding hip screws versus cannulated screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures. Our secondary objective is to determine the impact on health-related quality of like (Short Form-12, SF-12), functional outcomes (Western Ontario McMaster Osteoarthritis Index, WOMAC) and health utility (Euro-Qol-5D, EQ-5D). We propose a multi-center, concealed randomized trial design using minimization to determine patient allocation. Surgeons will use one of two surgical strategies in patients who have sustained a femoral neck fracture. The first strategy involves fixation of the fracture with multiple small diameter cancellous screws (i.e., cancellous screw group). The second treatment strategy involves fixation of the fracture with a single larger diameter screw with a side plate (i.e., sliding hip screw group). Study personnel will monitor critical aspects of peri-operative care and rehabilitation for protocol deviations. We will assess patients at hospital discharge, 2 weeks, 10 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery. The primary outcome is revision surgery within 2 years of the initial surgery. The secondary outcomes include patient quality of life (Short Form-12, SF-12), function (Western Ontario McMaster Osteoarthritis Index, WOMAC), and health utility (EuroQol-5D, EQ-5D). We will independently adjudicate revision surgery rates at regular intervals up to 2 years. This trial will not only change current orthopaedic practice, but will set a benchmark for the conduct of future orthopaedic trials.