The Effects of Tourniquet Use in Total Knee Arthroplasty

April 24, 2015 updated by: Wang Kai, Peking University People's Hospital

The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Short-duration tourniquet group
The tourniquet was inflated immediately before cement application and deflated after its hardening
Procedure: Short-duration tourniquet
Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening
ACTIVE_COMPARATOR: Long-duration tourniquet group
The tourniquet was inflated immediately before incision and deflated after the hardening of the cement
Procedure: Long-duration tourniquet
Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative blood loss
Time Frame: within operation
within operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Thigh pain measured by Visual Analogue Scale/Score (VAS)
Time Frame: 1 day, 2 day, 1 week, 2 week and 6 week after surgery
1 day, 2 day, 1 week, 2 week and 6 week after surgery
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
1 day, 2 day, 1week, 2 week and 6 week after surgery
Postoperative blood loss measured by drainage volume
Time Frame: 1 day and 2 day after surgery
1 day and 2 day after surgery

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

Investigators

  • Study Director: Jianhao Lin, M.D., Peking University People's Hospital

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

January 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (ESTIMATE)

April 29, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUPH

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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