ISRCTN96308751
Completed
未知
Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE): a multicenter randomized controlled trial
Stryker Trauma GmbH (Germany)0 sites736 target enrollmentOctober 18, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Trochanteric fracture
- Sponsor
- Stryker Trauma GmbH (Germany)
- Enrollment
- 736
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 05/04/2012:
- •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
- •Previous inclusion criteria:
Exclusion Criteria
- •Current exclusion criteria as of 05/04/2012:
- •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
Outcomes
Primary Outcomes
Not specified
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