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. Over 60 clinical sites in Canada, the United States, Europe, Australia, New Zealand, and Africa are participating in the trial.
HEALTH is a multicentre, randomized controlled trial in which 1,500 patients with displaced femoral neck fractures were randomized 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 minimization to ensure balance between intervention groups for the following factors: age, pre-fracture living, pre-fracture functional status, American Society for Anesthesiologists (ASA) Class, and clinical site. Data analysts and the HEALTH Steering Committee are blinded to the surgical allocation throughout the trial.
The results of the HEALTH trial will make an important contribution to orthopaedic surgical literature and are likely to lead to changes in orthopaedic practice. Identifying the optimal approach to arthroplasty has the potential to improve the lives of hundreds of thousands of patients and to reduce the economic burden associated with hip fractures. If this trial shows that one approach is superior to the other, it will revolutionize the treatment of hip fractures globally and may potentially lead to the establishment of new clinical guidelines for treatment of displaced femoral neck fractures. In addition to the clinical impact, the HEALTH trial also has the potential to impact orthopaedic trial conduct. Through this trial, we will build collaborative relationships among countries and between clinical centres. This trial will also contribute to challenging the dogma that surgical trials are doomed to be confined to small single centre initiatives.