Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery

March 2, 2014 updated by: Narunas Porvaneckas, Vilnius University

Influence of the Intraoperative Tourniquet Application Method on the Perioperative Blood Loss, Frequency of Transfusion and Close Postoperative Outcomes in Primary Total Knee Arthroplasty Patients

Different strategies of tourniquet application during elective primary total knee arthroplasty are thought to be associated with different outcomes. In that context, the study investigates different tactics in the search of optimal application of the tourniquet and the related fluid management during 24 perioperative hours.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The optimal application of tourniquet should reduce perioperative blood loss, create bloodless operative field, improve cementing technique and shorten surgery time. Meanwhile, inadequate application may increase the risk of deep vein thrombosis and pulmonary thromboembolism. Previous attempts to compare the tourniquet strategies in respect to the perioperative blood loss did not show significant difference. The investigators use the volume loading test aiming to optimize the fluid status and obtain the hemoglobin concentration in the conditions of standardized plasma dilution. The test is deployed just before the surgery and after postoperative 24 hrs in ICU. Functional outcomes and possible length of hospital stay is also evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, LT-04130
        • Republic Vilnius University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with osteoarthritis of the knee undergoing total knee arthroplasty with spinal-epidural anesthesia
  • Age > 50 and < 80 years
  • ASA (American Society of Anesthesiology Classification) II physical status
  • Signed informed consent form

Exclusion Criteria:

  • History of a bleeding disorder
  • Current chronic anticoagulation therapy
  • History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
  • Anemia before surgery required blood transfusion
  • ASA I, ASA>=III physical status
  • Age < 50 and > 80 years
  • BMI (Body Mass Index) < 20 and > 40kg/m2
  • Intravascular fluid infusion within 24 hours before study
  • Chronic non-steroidal anti-inflammatory drug use (more than 6month daily use)
  • Rheumatoid arthritis
  • Diabetes mellitus
  • Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
  • Alcohol intake 5 U daily
  • Contraindication to epidural catheter insertion
  • Surgery not by project surgeon
  • Participation in the other study
  • Active malignancy
  • Previous open knee surgery

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: I tourniquet tactic
Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after bone cement set.
Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Names:
  • Volume loading test
OTHER: II tourniquet tactic
Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.
Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Names:
  • Volume loading test
OTHER: III tourniquet tactic
Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after wound closure
Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Names:
  • Volume loading test
OTHER: IV control group
Do not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.
Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Names:
  • Volume loading test

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perioperative blood loss.
Time Frame: Before (baseline) the surgery and 24 hrs postoperatively
The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.
Before (baseline) the surgery and 24 hrs postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Wound healing
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Hemodilution
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Cardiac stroke volume
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Body temperature
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Pain (Visual Analog Scale)
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Number of opiate injections
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Straight-leg raising test
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Timed up and go test
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Knee flexion, extension, extension lag
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Knee swelling
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively
Complications
Time Frame: Within 6 days postoperatively
Within 6 days postoperatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vilnius University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Narunas Porvaneckas, PhD, Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP-001

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