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

全髋关节置换术与半髋关节置换术的髋部骨折评估替代方案（健康）

• 批准号: 8729466
• 负责人: THOMAS A. EINHORN
• 金额: --
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-15 至 2016-02-08
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8729466
• 关键词: Advocate; American; Arthroplasty; Australia; Benchmarking; Canada; Case Report Form; Confidence Intervals; Data; Data Quality; Deep Vein Thrombosis; Degenerative polyarthritis; Dislocations; Economic Burden; Europe; Evaluation; Event; Femoral Fractures; Femoral Neck Fractures; Funding; Future; Health; Health Care Costs; Hemorrhage; Hip Fractures; Hip region structure; Hospitals; Impairment; Individual; Infection; Lead; Left; Maintenance; Manuals; North America; Online Systems; Ontario; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Patients; Phase; Pilot Projects; Procedures; Prosthesis Loosenings; Protocols documentation; Quality of life; Questionnaires; Randomized; Recruitment Activity; Repeat Surgery; Reporting; Research Design; Research Personnel; Risk; Sample Size; Site; Surgeon; System; Techniques; Testing; Time; United States National Institutes of Health; Western Ontario and McMaster Universities Arthritis Index; adjudicate; adjudication; base; cost effectiveness; design; follow-up; functional outcomes; health related quality of life; hip replacement arthroplasty; improved; improved functioning; indexing; innovation; mortality; operation; pilot trial; primary outcome; public health relevance; randomized trial; secondary outcome

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.

描述（由申请人提供）：髋部骨折在美国发生280,000例，每周超过5,000例。在接下来的40年里，髋部骨折的数量每年可能超过50万例，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%的死亡率和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治疗。存在两种常见的髋关节置换术，全髋关节置换术（THA）和半髋关节置换术（HA）。半关节置换术（HA）的支持者关注于降低脱位率、降低深静脉血栓形成率、缩短手术时间、减少出血量以及技术要求较低的手术。支持THA的外科医生认为THA在改善患者功能和改善生活质量方面有好处。先前研究的方法局限性，以及它们的小样本量和广泛的置信区间，使得最佳的操作方法无法解决。目的：在50岁以上的股骨颈移位骨折患者中，采用THA与HA作为手术治疗时，2年后再次手术的比率是多少？我们也会评估病人的功能和生活质量。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出的确定性随机试验的先锋阶段，其中包括美国的200名持续移位的股骨颈骨折患者。这项研究将在美国12个地点招募100多名患者，并继续跟踪来自试点研究的100名患者。患者将被随机分配到THA或HA，并由具有该技术专长的外科医生进行治疗。我们将独立判断翻修手术率，并收集出院时、1周、10周、6、9、12、18和24个月的功能结局数据。假设：我们假设与半髋关节置换术相比，全髋关节置换术在24个月时具有相似或更低的再手术率（主要结局）和更高的功能结局评分（次要结局）。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进行设定一个基准。