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Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01559532
First Posted: March 21, 2012
Last Update Posted: March 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
  Purpose
This is an observational study to analyze the influence of surgery duration and tourniquet time in the incidence of deep venous thrombosis (DVT) in patients that had undergone total knee arthroplasty (TKA).

Condition
Deep Vein Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Tourniquet Use and Surgery Duration on the Incidence of Deep Vein Thrombosis in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Deep vein thrombosis [ Time Frame: 7 days ]
    Deep vein thrombosis confirmed by ascending venography performed 7 days after total knee arthroplasty.


Enrollment: 78
Study Start Date: February 2008
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ATK patients
Patients from our institution that underwent cemented TKA for degenerative knee disorders.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Seventy-eight consecutive patients from our institution underwent cemented TKA for degenerative knee disorders and then underwent AV, for which they gave informed consent, at a point between 7 and 12 days after surgery, after having been discharged from the hospital.
Criteria

Inclusion Criteria:

  • patients that underwent cemented total knee arthroplasty

Exclusion Criteria:

  • post-operative infection
  • inadequate follow-up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559532


Locations
Brazil
Orthopedics Department - University of Sao Paulo General Hospital
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Director: Arnaldo J Hernandez, Prof. Dr. Orthopedics and Traumatology Department - University of Sao Paulo General Hospital
  More Information

Publications:

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01559532     History of Changes
Other Study ID Numbers: 222
First Submitted: March 13, 2012
First Posted: March 21, 2012
Last Update Posted: March 21, 2012
Last Verified: March 2012

Keywords provided by University of Sao Paulo General Hospital:
Deep vein thrombosis
Thromboembolism
Tourniquet
Knee prosthesis.

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases