Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation (NCT01380444) | Clinical Trial Compass
CompletedNot Applicable
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation
United States880 participantsStarted 2011-12
Plain-language summary
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult men or women aged 18 years and older (with no upper age limit).
✓. 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).
✓. Low energy fracture (defined as a fall from standing height).
✓. No other major trauma.
✓. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
✓. Anticipated medical optimization of the patient for operative fixation of the proximal femur.
✓. 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.)
✓. Provision of informed consent by patient or proxy.
Exclusion criteria
✕. 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).
✕. Retained hardware around the affected proximal femur.
✕. Infection around the proximal femur (i.e., soft tissue or bone).
✕. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).