Can a Multimodal Approach Improve the Outcome of Patients With a Proximal Femoral Fracture?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- postoperative complications
研究概览
简要总结
This study is designed to compare the outcome of patients with proximal femoral fractures with different perioperative regimes: a group with a multimodal intervention and a control group.
详细描述
Femoral neck fractures constitute both a social and economic challenge. The one year mortality of affected patients amounts to 33%, wherein cardio-vascular complications are the major contributor. It is an objective of the present study to investigate whether a multi-modal perioperative intervention can improve the outcome of these patients.
We plan to carry out a prospective randomized controlled clinical study. Patients with an age above 60 years and proximal femoral fractures (femoral neck fractures or pertrochanteric femoral fractures) are to be included. These are divided into two groups, K and M. General anaesthesia is applied to both groups. In group K a commonly used therapy will be applied whereas in group M an intesified perioperative care will be carried out. The objectives are to provide sufficient analgesia, normotonia and normothermia. Hence, a femoral catheter is applied for pain therapy already preoperatively. Moreover, the pulmonal situation is improved by means of oxygen as needed. The cardiovascular situation is evaluated and optimized by means of extended hemodynamic monitoring both pre- and postoperatively. If needed, the nutrition of the patients is supplemented with highly caloric drinks.
A primary common endpoint is the appearance of postoperative complications. These include cardiovascular, cerebrovascular, pulmonal, renal and surgical complications. Secondary endpoints are mortality, duration of the stay at the hospital and intensive care duration. It is the objective of the study to reduce the probability for at least one postoperative complication from 50% to 25% (α=0,05 and 1-β=0,80). To this end 132 patients would have to be included in the study.
All participants are to be contacted by phone one year after the surgery and their health situation is to be determined.
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
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proximal femoral fracture (femoral neck fracture/ pertrochanteric femoral fracture)
- •Age ≥ 60 years
- •written informed consent
排除标准
- •pathological fracture
- •multiple trauma
- •fracture during a hospital stay due to a different disease
研究组 & 干预措施
K group
commonly used therapy
M group
multimodal intervention
干预措施: PulsioFlex® Monitoring (Device)
结局指标
主要结局
postoperative complications
时间窗: The participants will be followed for the duration of hospital stay, an expected average of 14 days
postoperative complications: cardiovascular, cerebrovascular, pulmonal, renal and surgical complications
次要结局
- duration of the stay at the hospital(1 year)
- intensive care duration(1 year)
- mortality(1 year)
