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

使用替代植入物进行固定治疗髋部骨折：Multi-c

• 批准号: 7515956
• 负责人: Marc F. Swiontkowski
• 金额: $ 34.72万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7515956
• 关键词: Accounting; American; Applications Grants; Asia; Australia; Benchmarking; Caliber; Canada; Caring; Degenerative polyarthritis; Depth; Disabled Persons; Failure; Femoral Neck Fractures; Fracture; Fracture Fixation; Funding; Future; Health; Hip Fractures; Hip region structure; Hospitals; Human Resources; Impairment; Implant; Individual; Infection; Institutes; Length of Stay; Life; Methods; Monitor; Necrosis; Ontario; Operative Surgical Procedures; Orthopedics; Outcome; Patients; Persons; Protocols documentation; Quality of life; Questionnaires; Randomized Controlled Clinical Trials; Rate; Rehabilitation therapy; Research; Research Personnel; Score; Side; Site; Slide; South America; Surgeon; United States; Week; adjudicate; design; disability; disability-adjusted life years; functional outcomes; health related quality of life; improved; indexing; mortality; musculoskeletal injury; sample fixation; trial comparing

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.

描述（由申请人提供）： 髋关节骨折发生在280，000美国人（每周超过5，000）和36，000加拿大人（每周超过690）每年。髋关节骨折与1年内30%的死亡率相关，并严重暂时性，有时是永久性的独立性和生活质量受损。全世界每年有450万人因髋部骨折致残，预计今后40年将增加到2 100万残疾人。髋部骨折比任何其他肌肉骨骼损伤占更多的住院天数，占骨折住院天数的三分之二以上。髋部骨折导致的残疾调整生命年损失在全球所有原因残疾中排名前十。确定内固定的最佳方法可能会改善成千上万患者的生活。我们的主要目的是评估滑动髋螺钉与空心螺钉固定对股骨颈骨折患者2年翻修手术率的影响。我们的次要目的是确定对健康相关质量（简表-12，SF-12）、功能结局（西安大略麦克马斯特骨关节炎指数，WOMAC）和健康效用（Euro-Qol-5D，EQ-5D）的影响。我们提出了一个多中心，隐藏的随机试验设计，使用最小化来确定患者分配。外科医生将在股骨颈骨折患者中使用两种手术策略之一。第一种策略涉及用多个小直径松质骨螺钉固定骨折（即，松质骨螺钉组）。第二种治疗策略涉及用带有侧板的单个较大直径螺钉固定骨折（即，滑动髋螺钉组）。研究人员将监测围手术期护理和康复的关键方面是否存在方案偏离。我们将在出院时、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。主要结局是初次手术后2年内的翻修手术。次要结局包括患者生活质量（简表-12，SF-12）、功能（西安大略麦克马斯特骨关节炎指数，WOMAC）和健康效用（EuroQol-5D，EQ-5D）。我们将定期独立判定翻修手术率，最长2年。这项试验不仅将改变目前的骨科实践，而且将为未来骨科试验的开展设定基准。