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

描述（由申请人提供）： 问题的范围：28万美国人发生髋关节骨折，每周超过5,000人。在接下来的40年里，每年髋骨骨折的人数可能超过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%的死亡率和独立性和生活质量受损的风险。治疗选择：髋关节骨折通常采用髋关节置换术或关节成形术治疗。存在两种常见类型的关节置换术-全髋关节置换术（THA）和半髋关节置换术（HA）。半关节置换术（HA）的倡导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、减少失血量和降低手术技术要求。支持THA的外科医生认识到改善患者功能和提高生活质量的益处。以往研究的方法学局限性，以及样本量小和置信区间宽，使得最佳手术入路尚未解决。目的：初步研究：评估进行一项大型随机试验的可行性（招募、依从性和随访），该试验比较了50岁以上接受THA或HA治疗的移位股骨颈骨折患者。连续性研究：在50岁以上的移位性股骨颈骨折患者中，使用THA与HA作为手术治疗时，2年时的再次手术率是多少？我们还将评估患者的功能和生活质量。研究设计：我们提出了一项PILOT研究，以评估多中心、隐蔽随机试验设计的可行性，比较全髋关节置换术（THA）与半髋关节置换术（HA）治疗移位性股骨颈骨折患者。本初步研究将在10个美国研究中心招募100例患者：（1）Boston Medical Center，Boston，MA，（2）Lahey Medical Center，Burlington，MA，（3）Greenville Hospital Systems，Greenville，SC，（4）University of辛辛那提，辛辛那提，OH，（5）East Texas Medical Center，泰勒，TX，（6）托马斯杰斐逊医院，费城，PA，（7）迈阿密谷医院，代顿，OH，（8）马约诊所，罗切斯特，MN，（9）圣伊丽莎白健康中心，扬斯敦，OH，和（10）杜克大学医学中心，达勒姆，NC。患者将被随机分配到THA或HA组，并由具有该技术专业知识的外科医生进行治疗。我们将独立判定翻修手术率，并收集初步研究出院时、2周、10周、3个月、6个月、9个月和12个月的功能结局数据。假设：对于该试验，我们假设我们的招募估计、患者随访、研究依从性和数据质量将足够高，以支持大型关键RCT的可行性。对于大型试验，我们假设与半髋关节置换术相比，全髋关节置换术在24个月时的再次手术率（主要结局）相似或更低，功能结局评分（次要结局）更高。潜在影响：本试验不仅将改变当前的骨科实践，而且将为未来骨科试验的开展设定基准。

DESCRIPTION (provided by applicant): Scope of the Problem: 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. Treatment Options: 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: Pilot Study: To assess the feasibility (recruitment, compliance, and follow-up) of conducting a large randomized trial comparing patients over age 50 years with a displaced femoral neck fracture treated with either THA or HA. Definitive Study: In patients over 50 years who have sustained a displaced femoral neck fracture, what is the rate of reoperation 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: We propose a PILOT study to evaluate the feasibility of a multicenter, concealed randomized trial design, comparing total hip arthroplasty (THA) versus hemi-arthroplasty (HA) in patients with displaced femoral neck fractures. This pilot study will recruit 100 patients, across 10 US sites: (1) Boston Medical Center, Boston, MA, (2) Lahey Medical Center, Burlington, MA, (3) Greenville Hospital Systems, Greenville, SC, (4) University of Cincinnati, Cincinnati, OH, (5) East Texas Medical Center, Tyler, TX, (6) Thomas Jefferson Hospital, Philadelphia, PA, (7) Miami Valley Hospital, Dayton, OH, (8) Mayo Clinic, Rochester, MN, (9) St. Elizabeth Health Center, Youngstown, OH, and (10) Duke University Medical Center, Durham, NC. 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, 2 weeks, 10 weeks, 3, 6, 9, and 12 months for the pilot study. Hypothesis: For this pilot, we hypothesize that our recruitment estimates, patient follow-up, study compliance, and data quality will be sufficiently high to support feasibility of a large pivotal RCT. For the large trial, 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. Potential Impact: This trial will not only change current orthopaedic practice, but will set a benchmark for the conduct of future orthopaedic trials.