Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

January 28, 2009 updated by: Haute Ecole de Santé Vaud

Validation of a Procedure Using Bioimpedance to Measure the Edema of Lower Leg of Patients After Total Knee Surgery

The purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current measurement techniques of edema are not adapted or not convenient for assessment in the post surgical environment. Developement of a convenient, quick and reliable method could be useful to facilitate edema evaluation in this context.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • 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

  • Switzerland
      • Lausanne, Switzerland, 1005
        • Département de l'Appareil Locomoteur - CHUV

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

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knee replacement surgery

Exclusion Criteria:

  • pacemaker
  • cardiac defibrillator
  • other metallic implant than knee arthroplasty

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bioimpedance ratio right/left
Time Frame: presurgery, 2 and 8 days post surgery
presurgery, 2 and 8 days post surgery

Collaborators and Investigators

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

Sponsor

Haute Ecole de Santé Vaud

Collaborators

University of Lausanne Hospitals
University of Applied Sciences of Western Switzerland

Investigators

  • Principal Investigator: Claude A Pichonnaz, physiother., Haute Ecole de Santé Vaud
  • Study Director: Brigitte M Jolles, PhD MER MSc, Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
  • Principal Investigator: Correvon Marc, Engineer, Haute Ecole Vaudoise d'Ingénierie et de Gestion

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, 2008

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (ESTIMATE)

March 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HECVSante01
  • SAGE-X 19860

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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