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
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Bleeding related index
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Joint replacement
Intertrochanteric fracture patients were treated with joint replacement surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed.
干预措施: Joint replacement surgery (Procedure)
Intramedullary nail fixation
Intertrochanteric fracture patients were treated with intramedullary nail fixation surgery.The postoperative drainage volume, blood transfusion volume, intraoperative blood loss, operative time, early weight bearing time will be recorded, and postoperative pulmonary infection, urinary tract infection, bedsore incidence and postoperative functional rehabilitation will be observed.
干预措施: Intramedullary nail fixation (Procedure)
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)
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