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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drainage Tube
Tranexamic Acid
Sodium Chloride 0.9%
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Qilu hospital of Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No Drainage

Drainage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative blood loss
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Haemoglobin
Reactive blood loss
Hematocrit
Reactive blood loss
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.
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.
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.
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.
Circumference of shank Postoperative Day One
indirectly reflects the latent blood loss
Circumference of shank Postoperative Day Three
indirectly reflects the latent blood loss
Circumference of shank Postoperative Day Five
indirectly reflects the latent blood loss
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
Number of Incision infection
The incision was red, swollen, hot and painful, and the blood routine showed that the leukocyte was increased.
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.
Number of delayed healing of the incision.
On the 14th day after operation, the incision did not heal.
Volume of drainage
Reactive blood loss

Secondary Outcome Measures

Activated partial thromboplastin time
Assessment of coagulation function in patients
Prothrombin time
Assessment of exogenous coagulation system
Concentration of D-dimer
Assessment of thrombotic diseases
Concentration of Fibrinogen
Assessment of coagulation function in patients

Full Information

First Posted
May 6, 2019
Last Updated
February 16, 2020
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT03954860
Brief Title
Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Official Title
Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Drainage
Arm Type
Experimental
Arm Description
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.
Arm Title
Drainage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Drainage Tube
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TXA
Intervention Description
Tranexamic acid (TXA) is an anti-fibrinolytic drugcan,which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9%
Other Intervention Name(s)
sodium chloride solution
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Postoperative blood loss
Description
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
Time Frame
The third day after operation
Title
Haemoglobin
Description
Reactive blood loss
Time Frame
The third day after operation
Title
Hematocrit
Description
Reactive blood loss
Time Frame
The third day after operation
Title
Hospital for special surgery knee score
Description
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
Title
Visual Analogue Scale Postoperative Day One
Description
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
Title
Visual Analogue Scale Postoperative Day Three
Description
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
Title
Visual Analogue Scale Postoperative Day Five
Description
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
Title
Circumference of shank Postoperative Day One
Description
indirectly reflects the latent blood loss
Time Frame
Postoperative Day One
Title
Circumference of shank Postoperative Day Three
Description
indirectly reflects the latent blood loss
Time Frame
Postoperative Day Three
Title
Circumference of shank Postoperative Day Five
Description
indirectly reflects the latent blood loss
Time Frame
Postoperative Day Five
Title
Number of blood transfusions
Description
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
Title
Number of Incision infection
Description
The incision was red, swollen, hot and painful, and the blood routine showed that the leukocyte was increased.
Time Frame
postoperative 3 month
Title
Number of hematoma formation
Description
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
Title
Number of delayed healing of the incision.
Description
On the 14th day after operation, the incision did not heal.
Time Frame
On the 14th day after operation
Title
Volume of drainage
Description
Reactive blood loss
Time Frame
Postoperative Day One
Secondary Outcome Measure Information:
Title
Activated partial thromboplastin time
Description
Assessment of coagulation function in patients
Time Frame
The third day after operation
Title
Prothrombin time
Description
Assessment of exogenous coagulation system
Time Frame
The third day after operation
Title
Concentration of D-dimer
Description
Assessment of thrombotic diseases
Time Frame
The third day after operation
Title
Concentration of Fibrinogen
Description
Assessment of coagulation function in patients
Time Frame
The third day after operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peilai Liu, Ph.D
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Qilu hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.
Citations:
PubMed Identifier
30245067
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.
Results Reference
background
PubMed Identifier
29939895
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.
Results Reference
background
PubMed Identifier
28355682
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.
Results Reference
background
PubMed Identifier
25750137
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.
Results Reference
background
PubMed Identifier
29257010
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.
Results Reference
background
PubMed Identifier
30985612
Citation
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.
Results Reference
background
PubMed Identifier
30915773
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.
Results Reference
background
PubMed Identifier
30871289
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.
Results Reference
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PubMed Identifier
32172314
Citation
Li S, Yang J, Watson C, Lu Q, Zhang M, Miao Z, Luo D, Liu P. Drainage relieves pain without increasing post-operative blood loss in high tibial osteotomy: a prospective randomized controlled study. Int Orthop. 2020 Jun;44(6):1037-1043. doi: 10.1007/s00264-020-04530-z. Epub 2020 Mar 14.
Results Reference
derived

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

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