Treatment of Reverse Oblique Intertrochanteric or Subtrochanteric Fractures With a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc) or Trochanteric Nails. A Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Compare the functional outcome and abductor muscle strength measured with Lafayette Manual Muscle Tester in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.
研究概览
简要总结
The purpose of this study is to compare the abductor muscle strength measured with a dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.
"Proximal femur locking plates" stands for both the PF-LCP (Synthes) and the PeriLoc (Smith & Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Patients with closed or type 1 open reverse oblique intertrochanteric fractures (AO 31 - A3) or subtrochanteric fractures (transverse fracture line, main fracture line maximum 5 cm distal from the lesser trochanter; proximal extension of fracture allowed)
- •Definitive fracture fixation with either a proximal femur locking plate or an intertrochanteric nail within 4 days after accident
- •Signed written informed consent (by the subject or legal guardian) 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 displacement of a femoral neck fracture
- •Additional fracture of one of the lower extremities that significantly affects the functional outcome
- •Additional injury of the lower limb that significantly affects the functional outcome
- •Fractures of the upper extremity if it affects the mobility of the patient
- •Type 2 or 3 open fracture
- •Drug or alcohol abuse
- •Active malignancy
- •ASA class V and VI
- •Inability to walk independently prior to injury
- •Neurological and psychiatric disorders that would preclude reliable assessment
- •Patient is not able to come to the regular FUs
- •Patients who have participated in any other device or drug related clinical trial within the previous month
- •Pregnancy (tested with a urine pregnancy test) or women planning to conceive within the study period
结局指标
主要结局
Compare the functional outcome and abductor muscle strength measured with Lafayette Manual Muscle Tester in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.
时间窗: one year
As hip abductors are the most important muscles around the hip joint, the primary outcome parameter will involve objectively measuring hip abductor strength. Muscle strength will be assessed with a portable handheld dynamometer (Model 01163, Lafayette Instrument Company, Lafayette, IN, USA).
次要结局
- Pain scores on the Visual Analog Scale(one year)
- Surgical details(Initial hospitalization)
- Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)(Initial hospitalization)
- Patient outcome(one year)
- Local complications(one year)
- Patient satisfaction with the Visual Analogue Scale(one year)
- Abductor muscle function with the Trendelenburg sign analysis(one year)
- Quality of reduction(one year)
- Revision rate(one year)
- Systemic or general complications(one year)