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

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ClinicalTrials.gov Identifier: NCT03954860
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE August 6, 2018
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Postoperative blood loss [ Time Frame: The day after the operation ]
    Total blood loss preoperative blood volume =(preoperative hematocrit-postoperative Hematocrit) + transfusion volume.
  • Haemoglobin [ Time Frame: The day after the operation ]
    Reactive blood loss
  • Hematocrit [ Time Frame: The day after the operation ]
    Reactive blood loss
  • Activated partial thromboplastin time [ Time Frame: The day after the operation ]
    Assessment of coagulation function in patients
  • Prothrombin time [ Time Frame: The day after the operation ]
    Assessment of exogenous coagulation system
  • Concentration of D-dimer [ Time Frame: The day after the operation ]
    Assessment of thrombotic diseases
  • Concentration of Fibrinogen [ Time Frame: The day after the operation ]
    Assessment of coagulation function in patients
  • Hospital for special surgery knee score [ Time Frame: postoperative 1 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.
  • Color doppler ultrasound of lower limb blood vessel [ Time Frame: Through study completion, an average of 1 year ]
    To determine if any thrombosis were formed
  • 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.
  • Visual Analogue Scale Postoperative Day Two [ Time Frame: Postoperative Day Two ]
    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 [ 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03954860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Circumference of shank Postoperative Day One [ Time Frame: Postoperative Day One ]
    indirectly reflects the latent blood loss
  • Circumference of shank Postoperative Day Two [ Time Frame: Postoperative Day Two ]
    indirectly reflects the latent blood loss
  • Circumference of shank Postoperative Day Three [ Time Frame: Postoperative Day Three ]
    indirectly reflects the latent blood loss
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
Official Title  ICMJE Effect of no Drainage Tube on Blood Loss and Recovery After High Tibial Osteotomy
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 1.2 g of diluted saline solution containing tranexamic acid was dripped 20 ml before loosening tourniquet Postoperative intravenous drip of 100 ML sodium chloride solution containing 0.8 g 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 1 month after surgery. Throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • 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.
    Other Name: 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 Name: sodium chloride solution
Study Arms  ICMJE
  • 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 20 ml saline containing 1.2 g tranexamic acid was applied to the local area before loosening the tourniquet Postoperative intravenous drip of 100 ML sodium chloride solution containing 0.8 g tranexamic acid. No drainage tube was placed after operation.
    Interventions:
    • Drug: Tranexamic Acid
    • Drug: Sodium Chloride 0.9%
  • 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 20 ml saline containing 1.2 g tranexamic acid was applied to the local area before loosening the tourniquet Postoperative intravenous drip of 100 ML sodium chloride solution containing 0.8 g tranexamic acid. Drainage tube should be placed after operation.
    Interventions:
    • Other: Drainage Tube
    • Drug: Tranexamic Acid
    • Drug: Sodium Chloride 0.9%
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 6, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. be in good physical condition and able to tolerate surgery;
  2. according to the diagnostic criteria ("diagnostic criteria of Osteoarthritis" , Chinese Society of Rheumatology, 2010) , patients with knee osteoarthritis were definitely diagnosed;
  3. the presence of significant extraarticular deformity;
  4. The contralateral compartment had good cartilage;
  5. the course of diagnosis of Gonarthritis was more than 6 months
  6. 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 with acute joint injury, tuberculosis of the knee joint, tumor, rheumatism and rheumatoid knee arthritis;
  2. patients with serious primary diseases such as heart, brain, blood vessel, liver, kidney and hemopoietic system, mental disease;
  3. allergic constitution and drug allergy to tranexamic acid;
  4. having uncontrolled infection during the active period (positive for HIV, hepatitis B and Hepatitis C virus) ;
  5. other open operations related to knee manipulation within 6 months;
  6. prior to this study, subjects were subjected to other clinical trials;
  7. failure to meet the inclusion criteria, failure to comply with the protocol, inability to assess efficacy, or incomplete information that affects efficacy or safety assessment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: songlin Li, bachelor 053182166541 ext 0086 bysonglin@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954860
Other Study ID Numbers  ICMJE 2019041
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The datasets used and/or analysed during the current study are available from the overall study officials on reasonable request.
Responsible Party Qilu Hospital of Shandong University
Study Sponsor  ICMJE Qilu Hospital of Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Peilai Liu, Ph.D Qilu Hospital of Shandong University
PRS Account Qilu Hospital of Shandong University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP