NCT02627040Unknown不适用
A Prospective Randomized Trial of Intertrochanteric Femoral Fractures Treated With a Single Screw Versus a Two-integrated Screw Cephalo-medullary Nail.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Hip Function
研究概览
简要总结
The main goal of the study is to determine which cephalomedullary nail results in a better functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.
详细描述
Primary Hypotheses:
Patients who maintain their initial fracture reduction and subsequent position over time with minimal femoral neck shortening and varus will demonstrate significantly improved functional abilities, including gait and abductor function.
Secondary Objective:
- Whether radiographic differences in femoral neck shortening and varus collapse translate into a worse functional outcome to the patient.
- Whether there are differences in mortality between treatments
- Whether there is a time frame follow up after which there is no difference in outcomes.
- Evaluate the device used for fracture stabilization as a potentially contributing factor for maintenance of normal or near-normal abductor function and gait.
Primary Outcome:
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients surgically treated for an intertrochanteric femur fracture at Tampa General Hospital.
- •Skeletally mature patients over the age of 60; both genders.
- •Community ambulators.
排除标准
- •Patients with ipsilateral lower extremity injury
- •Patients under age 60
- •Co-existent, severe knee or back problems
- •Muscle contracture around the knee or hip joint
- •Individuals who have had TKA within 6 months
- •Body mass index (BMI; kg/m2) >40
- •Suspicious of pathologic fracture (tumor in origin)
- •Pre-op mobility: Non ambulatory; ambulatory indoors with living support
- •Cognitive impairment or dementia
- •Prisoners or impending incarceration
- •Homeless or no stable address.
结局指标
主要结局
Hip Function
时间窗: 6 months post-operatively
Hip Function measured with Harris Hip Score.
次要结局
- Hip Pain(6 months post-operatively)
- Functional outcome(6 months post-operatively)
- Walking ability(3 months post-operatively)
- Hip range of motion(6 months post-operatively)
研究者
研究点 (4)
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