Internal Fixation or Joint Replacement Therapy for Hip Fracture Patients Over 75 Years Old Combined With Multiple Internal Medicine Complications: a Prospective, Multicenter, Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Intertrochanteric Fractures
- 发起方
- Peking University People's Hospital
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bleeding related index
- 最后更新
- 8年前
概览
简要总结
To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.
详细描述
Patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. The unstable fractures were A2 and A3 (31 A2.2 and 3, and 31 A3.3) according to the AO classification. The investigators will use a prospective randomized approach to determine the treatment procedure for patients. The patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. All patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. The two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. The investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.
研究者
baoguojiang
Dean of Peking University People's Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association
Peking University People's Hospital
入排标准
入选标准
- •Intertrochanteric fractures of the femur need surgery
- •Male and female, age more than 75 years old
- •Combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders
- •The patient is still able to tolerate surgery through the anaesthesia and related department assessment
- •Signed written informed consent
排除标准
- •No complications associated with internal medicine
- •Mild fracture displacement and conservative treatment required
- •Multiple trauma involving more than one organ system
- •Known to have progressive malignant neoplasms
- •It is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study
结局指标
主要结局
Bleeding related index
时间窗: Three days after the operation
Postoperative drainage volume and bleeding volume during operation（Unit: ml）
次要结局
- Joint rehabilitation index(Three months after the operation)
- Functional rehabilitation index(Three months after the operation)
- Surgical related index(Three days after the operation)
- Complication rate(Three monthes after the operation)