A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 880
- 试验地点
- 47
- 主要终点
- Health Related Quality of Life
研究概览
简要总结
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.
详细描述
Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision surgery rate and complication rate. Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of femoral shaft fractures and improved function, provide compelling rationale for the conduct of a large, definitive trial.
This trial is a definitive, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- •Patients with a subtrochanteric fracture.
- •Patients with a pathologic fracture.
- •Patients with a reverse oblique fracture pattern, fracture AO Type 31-A
- •Obesity in the judgment of the attending surgeon.
- •Off-label use of the implant.
- •Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year).
- •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.
- •Patient is enrolled in another ongoing drug or surgical intervention trial.
- •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).
研究组 & 干预措施
1
Gamma3 Intramedullary Nails
干预措施: Gamma3 Intramedullary Nails (Stryker) (Procedure)
2
Sliding Hip Screws
干预措施: Sliding Hip Screws (Procedure)
结局指标
主要结局
Health Related Quality of Life
时间窗: Up to 104 weeks
To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQol-5D at 52 weeks in individuals with trochanteric fractures.
次要结局
- Fracture healing rates(Up to 104 weeks)
- Health Related Quality of Life(Up to 104 weeks)
- Revision surgery rates(Up to 104 weeks)
- Fracture-related adverse events(Up to 104 weeks)