Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Post-Operative Unstable Angina
研究概览
简要总结
Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. This technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty.
In this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 55 years
- •non-pathologic, displaced subcapital femoral neck fracture
- •designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon
- •able to ambulate ten feet prior to presentation
排除标准
- •unable to walk ten feet prior to hip fracture
- •multiple extremity trauma
- •pathologic fracture of the hip (including malignancy)
- •clinically recognized acute myocardial infarction within thirty days prior to enrollment
- •previously participated in the trial
- •symptoms associated with anemia
- •pre-existing metabolic bone disease
研究组 & 干预措施
Cemented Hip Hemiarthroplasty
This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN).
干预措施: Cemented Hip Hemiarthroplasty (Device)
Press-Fit Hip Hemiarthroplasty
This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN),
干预措施: VerSys Beaded FullCoat, Zimmer (Device)
结局指标
主要结局
Post-Operative Unstable Angina
时间窗: 1 week post-operation
Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.
Post-Operative Myocardial Infarction
时间窗: 1 week post-operation
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Mortality
时间窗: 1 year
Assessment of post-operative mortality at one-year.
次要结局
- Energy/Fatigue Scale(1 year)
- Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale(1 year)