ACTRN12612000520831终止未知
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 个研究点目标入组 736 人开始时间: 2012年5月16日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 736
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
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 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).
研究者
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