Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH).

Rationale:

Hip fractures occur in 280,000 Americans (over 5,000 per week) and 36,000 Canadians (over 690 per week) annually. The number of hip fractures is likely to exceed 500,000 annually in the United States and 88,000 in Canada. The estimated annual health care costs will reach a staggering $9.8 billion in the United States and $650 million in Canada. Hip fractures are associated with a 30% mortality rate and profound temporary and sometimes permanent impairment of independence and quality of life. Worldwide, 4.5 million persons are disabled from hip fractures yearly with an expected increase to 21 million persons living with disability in the next 40 years. Advocates of hemi-arthroplasty 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 total hip arthroplasty 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.

Objective:

In patients over 50 years of age who have sustained a displaced femoral neck fracture, what is the rate of revision surgery at 24 months when a total hip arthroplasty versus hemiarthroplasty is used as the surgical treatment?

Hypothesis:

Total hip arthroplasty will have similar or lower rates of revision surgery (primary outcome) and higher functional outcome scores (secondary outcome) at 24 months compared with hemi-arthroplasty. Total hip replacement will be a cost-effective intervention.

Study Design:

Multi-centre, concealed ‘expertise-based’ randomized trial design using minimization to determine patient allocation. Surgeons across North America, South America, Europe, Australia, Asia, and Africa will participate. In conventional surgical hip fracture trials, all surgeons involved in the trial have performed both total hip arthroplasties and hemiarthroplasties based on the randomization process. We propose an alternative randomized trial design that allocates patients to surgeons with expertise in total hip arthroplasty who are committed to performing only total hip arthroplasty, or to surgeons with expertise in hemiarthroplasty who are committed to performing only hemi-arthroplasty. Based upon their expertise, surgeons will use one of two surgical strategies in patients who have sustained a displaced femoral neck fracture. The first strategy involves total hip arthroplasty (i.e., Replacement of the femoral head and hip socket). The second treatment strategy involves a hemi-arthroplasty (i.e., replacement of the femoral head only). Study personnel will monitor critical aspects of peri-operative care and rehabilitation for protocol deviations. The primary clinical outcome measure is revision surgery within 2 years of surgery. The primary health-economic outcome measure is the Cost-utility ratio of total hip arthroplasty versus hemi-arthroplasty. The secondary outcomes include healthrelated quality of life (Short Form-12, SF-12), functional outcomes and mobility (Western Ontario McMaster Osteoarthritis Index, WOMAC, and Timed Up and Go test, TUG), and health outcomes measure (EuroQol-5D, EQ-5D). Data will be collected at hospital admission (baseline), 1 week, 2 weeks, 10 weeks, 6 months, 9 months, 12 months, 18 months, and 24 months after surgery. Revision surgery rates will be independently adjudicated.

Total hip arthroplasty will have similar or lower rates of revision surgery (primary outcome) and higher functional outcome scores (secondary outcome) at 24 months compared with hemi-arthroplasty.

Baseline, Surgery, 1 week, 2 weeks, 10 weeks, 6 months, 9 months, 12 months, 18 months, 24 months.

1. Total hip replacement;

2. Hemi-arthroplasty.