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The Effects of Tourniquet Use in Total Knee Arthroplasty

Primary Purpose

Blood Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short-duration tourniquet
Long-duration tourniquet
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring tourniquet, total knee arthroplasty, blood loss

Eligibility Criteria

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

Inclusion Criteria:

  • patients aged 50 years or over
  • classified as American Society of Anesthesiologists ASA 1-2.

Exclusion Criteria:

  • coagulopathy,
  • uncontrolled hypertension,
  • peripheral vascular disease and
  • patients with BMI≥35

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Short-duration tourniquet group

    Long-duration tourniquet group

    Arm Description

    The tourniquet was inflated immediately before cement application and deflated after its hardening

    The tourniquet was inflated immediately before incision and deflated after the hardening of the cement

    Outcomes

    Primary Outcome Measures

    Intraoperative blood loss

    Secondary Outcome Measures

    Thigh pain measured by Visual Analogue Scale/Score (VAS)
    Thigh swelling measured by circumference 10 cm proximal to the patella
    Postoperative blood loss measured by drainage volume

    Full Information

    First Posted
    April 15, 2015
    Last Updated
    April 24, 2015
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02429713
    Brief Title
    The Effects of Tourniquet Use in Total Knee Arthroplasty
    Official Title
    The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.
    Detailed Description
    Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Loss
    Keywords
    tourniquet, total knee arthroplasty, blood loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Short-duration tourniquet group
    Arm Type
    Experimental
    Arm Description
    The tourniquet was inflated immediately before cement application and deflated after its hardening
    Arm Title
    Long-duration tourniquet group
    Arm Type
    Active Comparator
    Arm Description
    The tourniquet was inflated immediately before incision and deflated after the hardening of the cement
    Intervention Type
    Procedure
    Intervention Name(s)
    Short-duration tourniquet
    Intervention Description
    Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening
    Intervention Type
    Procedure
    Intervention Name(s)
    Long-duration tourniquet
    Intervention Description
    Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement
    Primary Outcome Measure Information:
    Title
    Intraoperative blood loss
    Time Frame
    within operation
    Secondary Outcome Measure Information:
    Title
    Thigh pain measured by Visual Analogue Scale/Score (VAS)
    Time Frame
    1 day, 2 day, 1 week, 2 week and 6 week after surgery
    Title
    Thigh swelling measured by circumference 10 cm proximal to the patella
    Time Frame
    1 day, 2 day, 1week, 2 week and 6 week after surgery
    Title
    Postoperative blood loss measured by drainage volume
    Time Frame
    1 day and 2 day after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients aged 50 years or over classified as American Society of Anesthesiologists ASA 1-2. Exclusion Criteria: coagulopathy, uncontrolled hypertension, peripheral vascular disease and patients with BMI≥35
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianhao Lin, M.D.
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21161177
    Citation
    Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
    Results Reference
    background
    PubMed Identifier
    23018303
    Citation
    Hernandez AJ, Almeida AM, Favaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. doi: 10.6061/clinics/2012(09)12.
    Results Reference
    background

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    The Effects of Tourniquet Use in Total Knee Arthroplasty

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