Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

This study has been completed.

Sponsor:

Collaborators:

University of Applied Sciences of Western Switzerland

University of Lausanne Hospitals

Information provided by:

Haute Ecole Cantonale Vaudoise de Santé

ClinicalTrials.gov Identifier:

NCT00627770

First received: February 6, 2008

Last updated: January 28, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2008

Last Updated Date

January 28, 2009

Start Date ^ICMJE

January 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

bioimpedance ratio right/left [ Time Frame: presurgery, 2 and 8 days post surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00627770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Edema

Intervention ^ICMJE

Device: bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia

edema evaluation using bioimpedance

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

knee replacement surgery

Exclusion Criteria:

pacemaker
cardiac defibrillator
other metallic implant than knee arthroplasty

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00627770

Other Study ID Numbers ^ICMJE

HECVSante01, SAGE-X 19860

Has Data Monitoring Committee

Responsible Party

Claude Pichonnaz/ HES-professor and physiotherapist, HECVSanté (University of Applied Sciences in Health)

Study Sponsor ^ICMJE

Haute Ecole Cantonale Vaudoise de Santé

Collaborators ^ICMJE

University of Applied Sciences of Western Switzerland
University of Lausanne Hospitals

Investigators ^ICMJE

Principal Investigator:	Claude A Pichonnaz, physiother.	Haute Ecole Cantonale Vaudoise de Santé
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

Information Provided By

Haute Ecole Cantonale Vaudoise de Santé

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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