ACTRN12612000520831
Terminated
未知
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation (INSITE):A multi-centre randomized controlled trial to assess the impact of intramedullary nails versus sliding hip screws on health-related quality of life in patients with intertrochanteric fractures of the hip
Stryker Australia Ptd Ltd0 sites736 target enrollmentMay 16, 2012
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Stryker Australia Ptd Ltd
- Enrollment
- 736
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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