Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH):
A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck Fractures

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.
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 occur in 18.000 Dutch citizens annually.
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.

In patients over 60 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 hemi-arthroplasty is used as the surgical treatment?
Hypothesis: We hypothesize that 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.

We propose a multi-centre, concealed *expertise-based* randomized trial design
using minimization to determine patient allocation. In conventional surgical
hip fracture trials, all surgeons involved in the trial have performed both
total hip arthroplasties and hemi-arthroplasties 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
hemi-arthroplasty 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.

Potential Impact of Study: this trial will not only change current orthopaedic
practice, but will set a benchmark for the conduct of future orthopaedic
trials.

Hemiarthroplasty versus Total Hip Arthroplasty

Surgeons worldwide are currently using both surgical techniques (i.e., total
hip arthroplasties and hemi-arthroplasties). Arthroplasty has been used for
over 5 decades in the management of displaced femoral neck fractures.
Arthroplasty procedures (as with any surgical procedure of the lower extremity)
have potential risks that include wound infection, DVT, neurovascular injury,
compartment syndrome, and death. All patients eligible for the trial; however,
require surgical treatment. We will monitor all adverse events following
treatment across both arms. Our independent Data Monitoring Committee (DMC) and
Data Safety and management Committee (DSMC) will review this information at
regular intervals.