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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954860
• Other study ID #: 2019041
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: May 2019
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Simple knee medial compartment osteoarthritis High tibial osteotomy.

2. With varus deformity, medial proximal tibia angle <85°

3. Unilateral High tibial osteotomy

4. 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:

1. patients who underwent other knee surgery within 6 months

2. Preoperative combined anemia (Hb<100g/l)

3. Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases

4. Patient with preoperative coagulation abnormalities 5. Patients with allergies and patients allergic to TXA.

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Other:
• Drainage Tube
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.

Drug:
• Tranexamic Acid
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%
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 .

Locations

Country	Name	City	State
China	Qilu hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (8)

Chan JJ, Cirino CM, Huang HH, Poeran J, Mazumdar M, Parsons BO, Anthony SG, Galatz LM, Cagle PJ Jr. Drain Use is Associated with Increased Odds of Blood Transfusion in Total Shoulder Arthroplasty: A Population-Based Study. Clin Orthop Relat Res. 2019 Jul;477(7):1700-1711. doi: 10.1097/CORR.0000000000000728. — View Citation

Huang Z, Xie X, Li L, Huang Q, Ma J, Shen B, Kraus VB, Pei F. Intravenous and Topical Tranexamic Acid Alone Are Superior to Tourniquet Use for Primary Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Dec 20;99(24):2053-2061. doi: 10.2106/JBJS.16.01525. — View Citation

Kim KI, Kim HJ, Kim GB, Bae SH. Tranexamic acid is effective for blood management in open-wedge high tibial osteotomy. Orthop Traumatol Surg Res. 2018 Nov;104(7):1003-1007. doi: 10.1016/j.otsr.2018.07.019. Epub 2018 Sep 20. — View Citation

Legnani C, Oriani G, Parente F, Ventura A. Reducing transfusion requirements following total knee arthroplasty: effectiveness of a double infusion of tranexamic acid. Eur Rev Med Pharmacol Sci. 2019 Mar;23(5):2253-2256. doi: 10.26355/eurrev_201903_17273. — View Citation

Nishitani K, Kuriyama S, Nakamura S, Ito H, Matsuda S. A Multivariate Analysis on the Effect of No Closed Suction Drain on the Length of Hospital Stay in Total Knee Arthroplasty. Knee Surg Relat Res. 2019 Mar 1;31(1):25-30. doi: 10.5792/ksrr.18.013. — View Citation

Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378. — View Citation

Suh DW, Kyung BS, Han SB, Cheong K, Lee WH. Efficacy of Tranexamic Acid for Hemostasis in Patients Undergoing High Tibial Osteotomy. J Knee Surg. 2018 Jan;31(1):50-55. doi: 10.1055/s-0037-1600091. Epub 2017 Mar 29. — View Citation

Zhang Q, Zhang Q, Guo W, Liu Z, Cheng L, Zhu G. No need for use of drainage after minimally invasive unicompartmental knee arthroplasty: a prospective randomized, controlled trial. Arch Orthop Trauma Surg. 2015 May;135(5):709-13. doi: 10.1007/s00402-015-2192-z. Epub 2015 Mar 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative blood loss	Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.	The third day after operation
Primary	Haemoglobin	Reactive blood loss	The third day after operation
Primary	Hematocrit	Reactive blood loss	The third day after operation
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Circumference of shank Postoperative Day One	indirectly reflects the latent blood loss	Postoperative Day One
Primary	Circumference of shank Postoperative Day Three	indirectly reflects the latent blood loss	Postoperative Day Three
Primary	Circumference of shank Postoperative Day Five	indirectly reflects the latent blood loss	Postoperative Day Five
Primary	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
Primary	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
Primary	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
Primary	Number of delayed healing of the incision.	On the 14th day after operation, the incision did not heal.	On the 14th day after operation
Primary	Volume of drainage	Reactive blood loss	Postoperative Day One
Secondary	Activated partial thromboplastin time	Assessment of coagulation function in patients	The third day after operation
Secondary	Prothrombin time	Assessment of exogenous coagulation system	The third day after operation
Secondary	Concentration of D-dimer	Assessment of thrombotic diseases	The third day after operation
Secondary	Concentration of Fibrinogen	Assessment of coagulation function in patients	The third day after operation