Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial

作者：Mohit Bhandari, P.J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, HEALTH Investigators · 发表于：BMJ Open · 年份：2015 · DOI：10.1136/bmjopen-2014-006263 · 被引用次数：76 · 研究领域：Hip and Femur Fractures、Bone fractures and treatments、Bone health and osteoporosis research

INTRODUCTION: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures. METHODS AND ANALYSIS: HEALTH is a multicentre, randomised controlled trial where 1434 patients, 50 years of age or older, with displaced femoral neck fractures from international sites are randomised to receive either THA or HA. Exclusion criteria include associated major injuries of the lower extremity, hip infection(s) and a history of frank dementia. The primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes, patient quality of life, mortality and hip-related complications-both within 2 years of the initial surgery. We are using minimisation to ensure balance between intervention groups for the following factors: age, prefracture living, prefracture functional status, American Society for Anesthesiologists (ASA) Class and centre number. Data analysts and the HEALTH Steering Committee ar...