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

February 16, 2020 updated by: Qilu Hospital of Shandong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • TXA
Drug: 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 .
Other Names:
  • sodium chloride solution
Active Comparator: 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.
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.
Other Names:
  • TXA
Drug: 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 .
Other Names:
  • sodium chloride solution
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale Postoperative Day One
Time Frame: 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
Postoperative blood loss
Time Frame: The third day after operation
Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
The third day after operation
Volume of drainage
Time Frame: Postoperative Day One
Reactive blood loss
Postoperative Day One
Haemoglobin
Time Frame: The third day after operation
Reactive blood loss
The third day after operation
Hematocrit
Time Frame: The third day after operation
Reactive blood loss
The third day after operation
Hospital for special surgery knee score
Time Frame: 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.
postoperative 3 month
Visual Analogue Scale Postoperative Day Three
Time Frame: 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
Time Frame: 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
Time Frame: Postoperative Day One
indirectly reflects the latent blood loss
Postoperative Day One
Circumference of shank Postoperative Day Three
Time Frame: Postoperative Day Three
indirectly reflects the latent blood loss
Postoperative Day Three
Circumference of shank Postoperative Day Five
Time Frame: Postoperative Day Five
indirectly reflects the latent blood loss
Postoperative Day Five
Number of blood transfusions
Time Frame: 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
Postoperative Day Three
Number of Incision infection
Time Frame: postoperative 3 month
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
Time Frame: 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.
postoperative 3 month
Number of delayed healing of the incision.
Time Frame: On the 14th day after operation
On the 14th day after operation, the incision did not heal.
On the 14th day after operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Chair: Peilai Liu, Ph.D, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (Actual)

May 17, 2019

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 16, 2020

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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