Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity,
and in some cases, mortality. Currently the most common method of surgical treatment includes
the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting
evidence regarding which device has a lower revision surgery rate and complication rate.
Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of
femoral shaft fractures and improved function, provide compelling rationale for the conduct
of a large, definitive trial.

This trial is a definitive, multi-center, concealed randomized controlled trial. Surgeons
will use one of the two surgical strategies in patients who have sustained a trochanteric
fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will
occur at the time of hospital admission, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104
weeks.

Inclusion Criteria:

1. Adult men or women aged 18 years and older (with no upper age limit).

2. An intertrochanteric fracture (stable or unstable), AO Type 31-A1 or 31-A2, confirmed
with anteroposterior and lateral hip radiographs, computed tomography, or magnetic
resonance imaging (MRI).

3. Low energy fracture (defined as a fall from standing height).

4. No other major trauma.

5. Patient was ambulatory prior to fracture, though they may have used an aid such as a
cane or a walker.

6. Anticipated medical optimization of the patient for operative fixation of the proximal
femur.

7. Operative treatment within 7 days after the trauma.(Operative treatment should take
place as soon as possible as permitted by each institution's standard of care.)

8. Provision of informed consent by patient or proxy.

Exclusion Criteria:

1. Associated major injuries of the lower extremity (i.e., ipsilateral and/or
contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of
the ankle, knee, or hip).

2. Retained hardware around the affected proximal femur.

3. Infection around the proximal femur (i.e., soft tissue or bone).

4. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's
disease, renal osteodystrophy, or osteomalacia).

5. Patients with Parkinson's disease severe enough to increase the likelihood of falling
or severe enough to compromise rehabilitation.

6. Patients with a subtrochanteric fracture.

7. Patients with a pathologic fracture.

8. Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3.

9. Obesity in the judgment of the attending surgeon.

10. Off-label use of the implant.

11. Patients with a previous history of frank dementia that would interfere with
assessment of the primary outcome (i.e., EQ-5D at 1 year).

12. Likely problems, in the judgment of the Site Investigators, with maintaining
follow-up. We will, for example, exclude patients with no fixed address, those who
report a plan to move out of town in the next year, or intellectually challenged
patients without adequate family support.

13. Patient is enrolled in another ongoing drug or surgical intervention trial.

14. If the attending surgeon believes that there is another reason to exclude this patient
from INSITE. This reason will be documented on the case report forms (CRFs).