Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 18
- 主要终点
- Mobility measured with the "timed up & go"-test during hospital stay.
研究概览
简要总结
The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.
详细描述
To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 75 years and older
- •Closed unstable trochanteric fracture: AO 31 - A2 and A3
- •Low energy trauma (e.g.fall from standing height)
- •Definitive fracture fixation within 72 hrs. after admission
- •Indication for PFNA fixation (with or without augmentation)
- •Ability to walk independently (walking aids are allowed) prior to injury
- •Signed written informed consent and agreement to attend the planned FUs
- •Able to understand and read country national language at an elementary level
排除标准
- •Pathologic fracture
- •Polytrauma
- •Any additional fracture
- •Open fracture
- •Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- •Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
- •ASA class V and VI
- •Any implant at the same hip
- •Hemiplegia
- •Patients with legal guardian
- •Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month
- •Fractures and injuries opening into the articulation and vascular structure
- •Infection
- •Patients with clotting disorders
- •Patients with severe cardiac and / or pulmonary insufficiency
- •Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, N,N-dimethyl-p-toluidine)
- •Perforation of the femoral head into the joint with the guide wire used for the PFNA blade
- •Risk of potential leakage into the joint identified by using contrast fluid (PFNA Augmentation group only)
- •Intraoperative decision to use implants other than PFNA
结局指标
主要结局
Mobility measured with the "timed up & go"-test during hospital stay.
时间窗: 5 to 7 days postoperative
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again. Patient-perceived pain and exertion will be assessed after the test.
次要结局
- Local adverse events and revision rate(one year)
- Functional independence(1 week prior to operation)
- Pain(one year)
- Mortality(one year)
- Walking ability(one year)
- Systemic adverse events(one year)
- Timed up & go-test at follow-ups(one year)
- Quality of life(one year)
- Fracture risk prior to injury(1 week prior to operation)
- Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).(Intraoperative)
- Duration of hospital stay(one year)
- Return to pre-fracture residential status(one year)
- Implant migration(one year)
- Comorbidity(1 week prior to operation)