Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Volume of drainage
研究概览
简要总结
The objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube The clinical scores of patients and their possible risks were tracked. The investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. The implementation of the study will provide a new perioperative blood loss control program for High Tibial Osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.
详细描述
The condition of the patients was evaluated, and the total length of both lower limbs, anteroposterior position of knee and Mri of knee were included. The preoperative dose of tranexamic acid was calculated according to body weight of 20 mg / kg, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and after incision closure, 30 ml of normal saline solution containing 2 g of tranexamic acid was injected through drainage tube or subcutaneously. Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Arthroscopy was first used to further confirm the cartilage defect, and a new type of lower limb alignment meter and a customized precise osteotomy template were used to perform the osteotomy according to the preoperative plan. One group was not placed drainage tube, the other group was placed drainage tube. Visual analogue pain score (Vas) and American Special Surgical Hospital (HSS) knee function score were recorded 3 month after surgery. Throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.
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 (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Simple knee medial compartment osteoarthritis High tibial osteotomy.
- •With varus deformity, medial proximal tibia angle <85°
- •Unilateral High tibial osteotomy
- •informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process
排除标准
- •patients who underwent other knee surgery within 6 months
- •Preoperative combined anemia (Hb<100g/l)
- •Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
- •Patient with preoperative coagulation abnormalities
- •Patients with allergies and patients allergic to TXA.
研究组 & 干预措施
No Drainage
The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. No drainage tube was placed after operation.
干预措施: Tranexamic Acid (Drug)
No Drainage
The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. No drainage tube was placed after operation.
干预措施: Sodium Chloride 0.9% (Drug)
Drainage
The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Drainage tube should be placed after operation.
干预措施: Drainage Tube (Other)
Drainage
The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Drainage tube should be placed after operation.
干预措施: Tranexamic Acid (Drug)
Drainage
The preoperative dose of tranexamic acid was calculated according to 20 mg / kg body weight, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and 30 ml saline containing 2 g tranexamic acid was applied to the local area before loosening the tourniquet.Postoperative intravenous drip of 100 ML sodium chloride solution containing 20 mg / kg tranexamic acid. Drainage tube should be placed after operation.
干预措施: Sodium Chloride 0.9% (Drug)
结局指标
主要结局
Volume of drainage
时间窗: Postoperative Day One
Reactive blood loss
Haemoglobin
时间窗: The third day after operation
Reactive blood loss
Visual Analogue Scale Postoperative Day One
时间窗: Postoperative Day One
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Hospital for special surgery knee score
时间窗: postoperative 3 month
HSS is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Visual Analogue Scale Postoperative Day Three
时间窗: Postoperative Day Three
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day Five
时间窗: Postoperative Day Five
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Circumference of shank Postoperative Day One
时间窗: Postoperative Day One
indirectly reflects the latent blood loss
Hematocrit
时间窗: The third day after operation
Reactive blood loss
Circumference of shank Postoperative Day Five
时间窗: Postoperative Day Five
indirectly reflects the latent blood loss
Number of delayed healing of the incision.
时间窗: On the 14th day after operation
On the 14th day after operation, the incision did not heal.
Postoperative blood loss
时间窗: The third day after operation
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Circumference of shank Postoperative Day Three
时间窗: Postoperative Day Three
indirectly reflects the latent blood loss
Number of blood transfusions
时间窗: Postoperative Day Three
If the hemoglobin was \<80 g/l, allogeneic blood was transfused, and the number of blood transfusions were recorded.0 means no blood transfusion, and the larger the number is, the more blood transfusion.The maximum number does not exceed the total number of patients
Number of hematoma formation
时间窗: postoperative 3 month
After operation, the incision is swollen and has wave motion, but it is not hot or painful, and there will be blood outflow during puncture.
Number of Incision infection
时间窗: postoperative 3 month
The incision was red, swollen, hot and painful, and the blood routine showed that the leukocyte was increased.
次要结局
- Concentration of Fibrinogen(The third day after operation)
- Prothrombin time(The third day after operation)
- Concentration of D-dimer(The third day after operation)
- Activated partial thromboplastin time(The third day after operation)