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

Abstract

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 are blinded to the surgical allocation throughout the trial. Outcome analysis will be performed using a χ(2) test (or Fisher's exact test) and Cox proportional hazards modelling estimate. All results will be presented with 95% CIs.

Ethics and dissemination: The HEALTH trial has received local and McMaster University Research Ethics Board (REB) approval (REB#: 06-151).

Results: Outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences. We will communicate trial results to all participating sites. Participating sites will communicate results with patients who have indicated an interest in knowing the results.

Trial registration number: The HEALTH trial is registered with clinicaltrials.gov (NCT00556842).

Keywords: ORTHOPAEDIC & TRAUMA SURGERY; SURGERY.

Figure 1

Expertise-based randomised controlled trial. An expertise-based randomised controlled trial design randomises participants to surgeons with expertise in surgery A or to surgeons with expertise in surgery B.

Figure 2

Schedule of events. *Complete forms when and/or if applicable.

Figure 3

Strategies to enhance follow-up rates.