Cemented Versus Uncemented Arthroplasty in Elderly Patients With Displaced Femoral Neck Fractures: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Harris Hip Score
研究概览
简要总结
The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties.
The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.
详细描述
Femoral neck fracture is a common cause of suffering and premature mortality among the elderly. Riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction.
Mortality and morbidity varies between undisplaced and displaced femoral neck fractures.
Different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). The treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws.
The treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. Treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries.
Fixation of the femoral component with bone-cement is standard procedure in Europe today. To avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. These uncemented stems are mostly older design with poor track records. The use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •displaced fracture of the femoral neck
- •independent living
- •independent ambulation (with or without walking aids)
排除标准
- •pathological fracture
- •severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively
- •preexisting ipsilateral hip disease
- •neurological disease (e.g. M. Parkinson)
- •psychiatric disease which makes understanding or following instructions impossible
- •history of drug and alcohol abuse
结局指标
主要结局
Harris Hip Score
时间窗: 12 month
Our primary outcome variable is the Harris Hip Score at 12 month follow up. Harris Hip Score is an investigator reported tool evaluating hip function in four dimensions: Pain, function, absence of deformity and range of motion
次要结局
- Health related quality of life(12 month)
- Radiological follow up(12 month)
研究者
Christian Inngul
Consultant orthopeadic surgery
Stockholm South General Hospital