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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
The drainage tube drainage to guide the pus, blood and liquid accumulated between human tissues or in body cavity outside the body of High tibial osteotomy'patients.
Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
Sodium Chloride 0.9% is a solution of sodium chloride, which has the same osmotic pressure as animal or human plasma in physiological experiments or clinics, and can be used to dilute Tranexamic Acid .
Qilu hospital of Shandong University
Jinan, Shandong, China
Postoperative blood loss
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Time frame: The third day after operation
Haemoglobin
Reactive blood loss
Time frame: The third day after operation
Hematocrit
Reactive blood loss
Time frame: The third day after operation
Hospital for special surgery knee score
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.
Time frame: postoperative 3 month
Visual Analogue Scale 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.
Time frame: Postoperative Day One
Visual Analogue Scale 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.
Time frame: Postoperative Day Three
Visual Analogue Scale 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.
Time frame: Postoperative Day Five
Circumference of shank Postoperative Day One
indirectly reflects the latent blood loss
Time frame: Postoperative Day One
Circumference of shank Postoperative Day Three
indirectly reflects the latent blood loss
Time frame: Postoperative Day Three
Circumference of shank Postoperative Day Five
indirectly reflects the latent blood loss
Time frame: Postoperative Day Five
Number of blood transfusions
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
Time frame: Postoperative Day Three
Number of Incision infection
The incision was red, swollen, hot and painful, and the blood routine showed that the leukocyte was increased.
Time frame: postoperative 3 month
Number of hematoma formation
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.
Time frame: postoperative 3 month
Number of delayed healing of the incision.
On the 14th day after operation, the incision did not heal.
Time frame: On the 14th day after operation
Volume of drainage
Reactive blood loss
Time frame: Postoperative Day One
Activated partial thromboplastin time
Assessment of coagulation function in patients
Time frame: The third day after operation
Prothrombin time
Assessment of exogenous coagulation system
Time frame: The third day after operation
Concentration of D-dimer
Assessment of thrombotic diseases
Time frame: The third day after operation
Concentration of Fibrinogen
Assessment of coagulation function in patients
Time frame: The third day after operation
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