Hip Fracture Evaluation Alternatives of Total Hip vs Hemi-arthroplasty (HEALTH)

描述(申请人提供)：28万名美国人发生髋部骨折，每周超过5000人。在接下来的40年里，髋部骨折的数量可能每年超过50万，估计每年的医疗费用将达到惊人的98亿美元。髋部骨折患者有30%的死亡率以及独立性和生活质量受损的风险。髋部骨折通常采用髋关节置换术或关节置换术。关节置换术有两种常见类型，全髋关节置换术(THA)和半关节置换术(HA)。半关节置换术(HA)的倡导者注重减少脱位率，降低深静脉血栓形成的发生率，缩短手术时间，减少出血，以及对技术要求较低的程序。支持THA的外科医生认为改善患者功能和提高生活质量是有益的。先前研究的方法学局限性，以及它们的小样本量和由此产生的较大的可信区间，使得最佳手术入路尚未解决。目的：对于50岁以上的股骨颈移位骨折患者，采用人工全髋关节置换术与羟基磷灰石置换术治疗股骨颈骨折2年后再手术率分别是多少？我们还将评估患者的功能和生活质量。研究设计：为了最大限度地提高我们的随机患者的效率，我们建议将我们正在进行的试点研究扩展到我们提议的最终随机试验的先锋阶段，该试验涉及1316名患者，包括美国总共200名遭受股骨颈骨折移位的患者。这项研究将在美国12个地点再招募100名患者，并继续跟踪初步研究中的100名患者。患者将被随机分到全髋关节置换术或HA组，并由具有该技术专业知识的外科医生进行治疗。我们将独立裁决翻修手术率，并收集出院时、1周、10周、6个月、9个月、12个月、18个月和24个月的功能结果数据。假设：我们假设在24个月时，全髋关节置换术与半关节置换术相比，再次手术率(主要结果)相似或更低，而功能结果评分(次要结果)更高。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): Hip fractures occur in 280,000 Americans, over 5,000 per week. During the next 40 years, the number of hip fractures is likely to exceed 500,000 annually, and the estimated annual health care costs will reach a Staggering $9.8 billion. Hip fracture patients are at risk of a 30% mortality rate and impairment of independence and quality of life. Hip fractures are commonly treated with hip replacement, or arthroplasty. Two common types of arthroplasty exist, total hip arthroplasty (THA) and hemi-arthroplasty (HA). Advocates of hemi-arthroplasty (HA) focus upon reduced dislocation rates, lower rates of deep vein thrombosis, shorter operating times, less blood loss, and a technically less demanding procedure. Surgeons supporting THA perceive benefits in improving patient function and improving quality of life. Methodological limitations of previous studies, as well as their small sample sizes and resulting wide confidence intervals, have left the optimal operative approach unresolved. Objectives: In patients over 50 years who have sustained a displaced femoral neck fracture, what is the rate of re-operation at 2 years when THA versus HA is used as the surgical treatment? We will also evaluate patient function and quality of life. Study Design: To maximize the efficiency of our randomized patients, we propose an expansion of our ongoing pilot study into a vanguard phase of our proposed definitive randomized trial of 1, 316 patients, including 200 total patients in the US, who have sustained a displaced femoral neck fracture. This study will recruit 100 more patients across 12 US sites, and continue to follow the 100 patients from the pilot study. Patients will be randomized to either THA or HA and treated by surgeons with expertise in that technique. We will independently adjudicate revision surgery rates and collect functional outcome data at hospital discharge, 1 week, 10 weeks, 6-, 9-, 12-, 18- and 24-months. Hypothesis: We hypothesize that total hip arthroplasty will have similar or lower rates of re-operation (primary outcome) and higher functional outcome scores (secondary outcome) at 24 months compared with hemi-arthroplasty. This trial will not only change current orthopaedic practice, but will set a benchmark for the conduct of future orthopaedic trials.