Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Drainage Tube
* Drug: Tranexamic Acid
* Drug: Sodium Chloride 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 5. Patients with allergies and patients allergic to TXA.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No Drainage<br>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. | Drug: Tranexamic Acid<br>* Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.<br>* Other names: TXA;Drug: Sodium Chloride 0.9%<br>* 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 .<br>* Other names: sodium chloride solution;|
| Active Comparator: Drainage<br>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. | Other: Drainage Tube<br>* 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.<br>Drug: Tranexamic Acid<br>* Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.<br>* Other names: TXA;Drug: Sodium Chloride 0.9%<br>* 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 .<br>* Other names: sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative blood loss | Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume. | The third day after operation | 
| Haemoglobin | Reactive blood loss | The third day after operation | 
| Hematocrit | Reactive blood loss | 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. | 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. | 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. | 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. | Postoperative Day Five | 
| Circumference of shank Postoperative Day One | indirectly reflects the latent blood loss | Postoperative Day One | 
| Circumference of shank Postoperative Day Three | indirectly reflects the latent blood loss | Postoperative Day Three | 
| Circumference of shank Postoperative Day Five | indirectly reflects the latent blood loss | 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 | 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. | 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. | postoperative 3 month | 
| Number of delayed healing of the incision. | On the 14th day after operation, the incision did not heal. | On the 14th day after operation | 
| Volume of drainage | Reactive blood loss | Postoperative Day One | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activated partial thromboplastin time | Assessment of coagulation function in patients | The third day after operation | 
| Prothrombin time | Assessment of exogenous coagulation system | The third day after operation | 
| Concentration of D-dimer | Assessment of thrombotic diseases | The third day after operation | 
| Concentration of Fibrinogen | Assessment of coagulation function in patients | The third day after operation |