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

About this trial
This is an interventional treatment trial for Blood Loss focused on measuring tourniquet, total knee arthroplasty, blood loss
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
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
NCT ID
NCT02429713
First Posted
April 15, 2015
Last Updated
April 24, 2015
Sponsor
Peking University People's Hospital
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
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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
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The Effects of Tourniquet Use in Total Knee Arthroplasty
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