Outcome Comparison Between PFNA and InterTAN in Intertrochanteric Fractures
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
The purpose of this study is to determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture.
详细描述
With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.
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
- Double (Participant, Outcomes Assessor)
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
- •Adult men or women aged 18 years and older (with no upper age limit).
- •Fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- •Operative treatment of fractures within 14 days of presenting to the emergency room.
- •Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- •Anticipated medical optimalization for operative fixation of the hip.
- •Provision of informed consent by patient or legal guardian.
- •No other major trauma.
排除标准
- •Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- •Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- •Retained hardware around the affected hip.
- •Infection around the hip (i.e., soft tissue or bone).
- •Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
- •Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
- •Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. 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 support.
研究组 & 干预措施
Stable intertrochanteric fracture
The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.
干预措施: PFNA (Device)
Stable intertrochanteric fracture
The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.
干预措施: InterTAN (Device)
Unstable intertrochanteric fracture
The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.
干预措施: PFNA (Device)
Unstable intertrochanteric fracture
The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.
干预措施: InterTAN (Device)
结局指标
主要结局
Quality of life
时间窗: six months
Assessment the quality of life by SF-36 (The Short Form Health Survey), ADL (Activities of Daily Living), FIM (Functional Independence Measure).
次要结局
- Bone healing condition(Six months)
研究者
Peifu Tang
Chief, Professor
Chinese PLA General Hospital