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Does Tourniquet Use in Total Knee Replacement Improve Fixation

Sponsor
Per Aspenberg (Other)
Overall Status
Completed
CT.gov ID
NCT01470482
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
45
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: No use of tourniquet
  • Procedure: Tourniquet
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Does Tourniquet Use in Total Knee Replacement Improve Fixation
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. View protocol record [2 years]

      Measures the migration of the knee prosthesis

    Secondary Outcome Measures

    1. View Protocol Record [2 years]

      Meassures of total bledding, ROM, KOOS, Pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Motala hospital Motala Sweden

    Sponsors and Collaborators

    • Per Aspenberg

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Per Aspenberg, Professor, University Hospital, Linkoeping
    ClinicalTrials.gov Identifier:
    NCT01470482
    Other Study ID Numbers:
    • Ledin01
    • VR - 2009-6725).
    First Posted:
    Nov 11, 2011
    Last Update Posted:
    Jun 9, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Per Aspenberg, Professor, University Hospital, Linkoeping
    Total knee
    Tourniquet
    Blood loss
    pain
    range of motion
    Additional relevant MeSH terms:
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Jun 9, 2015