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NCT Number: NCT03954860

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu hospital of Shandong University

Jinan, Shandong, 250014, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drainage Tube

Other

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

Drug

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

Sodium chloride 0.9%

Drug

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

Primary outcomes

  1. Postoperative blood loss

    Time frame: The third day after operation

    Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.

  2. Haemoglobin

    Time frame: The third day after operation

    Reactive blood loss

  3. Hematocrit

    Time frame: The third day after operation

    Reactive blood loss

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Circumference of shank Postoperative Day One

    Time frame: Postoperative Day One

    indirectly reflects the latent blood loss

  9. Circumference of shank Postoperative Day Three

    Time frame: Postoperative Day Three

    indirectly reflects the latent blood loss

  10. Circumference of shank Postoperative Day Five

    Time frame: Postoperative Day Five

    indirectly reflects the latent blood loss

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. Volume of drainage

    Time frame: Postoperative Day One

    Reactive blood loss

Secondary outcomes

  1. Activated partial thromboplastin time

    Time frame: The third day after operation

    Assessment of coagulation function in patients

  2. Prothrombin time

    Time frame: The third day after operation

    Assessment of exogenous coagulation system

  3. Concentration of D-dimer

    Time frame: The third day after operation

    Assessment of thrombotic diseases

  4. Concentration of Fibrinogen

    Time frame: The third day after operation

    Assessment of coagulation function in patients

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 17, 2019
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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