NL-OMON44033已完成不适用
A Multi-Center Randomized Controlled Trial of Intramedullary Nails versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip - INSITE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Stryker
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult men or women aged 18 years and older (with no upper age limit).
- •2. A trochanteric fracture (stable or unstable) 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
- •7. Operative treatment within 7 days after the trauma*.
- •8. Provision of informed consent by patient or proxy.
- •*Operative treatment should take place as soon as possible as permitted by each
- •institution*s standard of care.
排除标准
- •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 rond de aangedane proximale 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.
- •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 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
- •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.
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