Does Tourniquet Use in Total Knee Replacement Improve Fixation

June 8, 2015 updated by: Per Aspenberg
Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.

We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.

Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.

Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

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

  • Sweden
      • Motala, Sweden
        • Motala 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

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary or secondary osteoarthritis without other severe disease (ASA 1-2).

Exclusion Criteria:

  • were inability to give informed consent,
  • rheumatic arthritis,
  • malignancy,
  • coagulation disorder or medical treatment influencing the coagulation,
  • liver disease,
  • severe heart disease or bilateral operation.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: No Tourniquet
We compare tourniquet or not in knee surgery
Procedure: No use of tourniquet
Tourniquet is not applied i 25 pts
Other Names:
  • No Tourniquet
Active Comparator: Tourniquet
We compare tourniquet or not in knee surgery
Procedure: Tourniquet
Use of tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
View protocol record
Time Frame: 2 years
Measures the migration of the knee prosthesis
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
View Protocol Record
Time Frame: 2 years
Meassures of total bledding, ROM, KOOS, Pain
2 years

Collaborators and Investigators

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

Sponsor

Per Aspenberg

Investigators

  • Study Director: Per Aspenberg, MD,PhD, Linkoeping University

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

August 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 3, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ledin01
  • VR - 2009-6725). (Other Identifier: EPN Linköping M59-06)

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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