Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)

One type of hip fracture, called a femoral neck fracture, involves a break in the narrow part
of the femur bone where the head of the femur is joined to the main shaft. The break can be
either undisplaced, which involves very little separation at the fracture site, or displaced,
in which there is substantial separation. Surgeons agree that the best surgical procedure for
an undisplaced fracture is internal fixation, in which a mechanical implant reconnects the
two separated segments of bone. For displaced fractures, surgeons usually choose between
internal fixation and a hip joint replacement.

There is more than one way to perform internal fixation. The majority of orthopaedic surgeons
currently favor the use of multiple small diameter cancellous screws. However, an alternative
method that uses a single large diameter screw attached to a sideplate, called a sliding hip
screw, has been gaining popularity and might reduce post-surgical complications and the need
for revision surgery. Which surgical method is best for the patient is unknown. This study
will compare the use of multiple small diameter cancellous screws versus a single sliding hip
screw on rates of revision surgery 2 years after patients sustain femoral neck fractures and
undergo internal fixation. The study will also compare the impact of the two different
surgical procedures on the overall health, function, and quality of life of patients. Results
from this study may impact current orthopaedic practice.

Participation in this study will last 2 years. Before surgery, participants will complete a
baseline assessment that will include x-rays, a medical history review, and a physical
examination. Participants will then be randomly assigned to undergo one of two types of
internal fixation surgeries for repairing their hip fractures. In one group of participants,
surgeons will use at least two small cancellous threaded screws that have a diameter of at
least 6.5 mm. In the other group of participants, surgeons will use a single large diameter
screw that is partially threaded. This screw, called a sliding hip screw, will be affixed to
the femur bone with a sideplate, and there will be no other fixations. All surgeons, who will
need to meet certain criteria to partake in the study, will follow the manufacturers'
technique guidelines for using either type of screw. Specific aspects of both the
pre-operative and post-operative care, such as the use of antibiotics and calcium
supplementation, will be standardized for all participants.

Follow-up assessments will be completed either by phone or in-person at the hospital or
clinic. They will occur 1, 2, and 10 weeks after surgery and 6, 9, 12, 18, and 24 months
after surgery. All assessments will include questionnaires and interviews on health status,
hip function, pain, and revision surgery. Some of the in-person assessments will also include
x-rays.

Inclusion Criteria:

- Fracture of femoral neck

- Operative treatment within 4 days for displaced fractures

- Operative treatment within 7 days for nondisplaced fractures

- Ambulatory before the injury

- Low energy trauma, such as falls from a sitting or standing position

- No other major trauma

Exclusion Criteria:

- Unsuited for both surgical treatments

- Associated major injuries of the lower extremities

- Retained hardware around the hip

- Infection around the hip

- Bone metabolic disorder (except for osteoporosis)

- Moderate or severe cognitive impairment

- Parkinson's disease or dementia

- Unable to complete the 2-year follow-up