Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

This study is currently recruiting participants.

Verified by Haute Ecole Cantonale Vaudoise de Santé, July 2008

Sponsors and Collaborators:	Haute Ecole Cantonale Vaudoise de Santé University of Applied Sciences of Western Switzerland University of Lausanne Hospitals
Information provided by:	Haute Ecole Cantonale Vaudoise de Santé
ClinicalTrials.gov Identifier:	NCT00627770

Purpose

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

Condition	Intervention
Edema	Device: bioimpedance spectroscopy (device : ImpediMed Imp SFB7, Brisbane, Australia)

MedlinePlus related topics: Edema Knee Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Validation of a Procedure Using Bioimpedance to Measure the Edema of Lower Leg of Patients After Total Knee Surgery

Further study details as provided by Haute Ecole Cantonale Vaudoise de Santé:

Primary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

edema evaluation using bioimpedance

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

knee replacement surgery

Exclusion Criteria:

pacemaker
cardiac defibrillator
other metallic implant than knee arthroplasty

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627770

Contacts

Contact: Claude A Pichonnaz, physiother.

004121314 69 35

cpichonn@hecvsante.ch

Locations

Switzerland
Département de l'Appareil Locomoteur - CHUV	Recruiting
Lausanne, Switzerland, 1005
Contact: Claude A Pichonnaz, physiother. 0041 21 3146935 cpichonn@hecvsante.ch
Contact: Bassin Jean-Philippe, physiother. 0041 21 3146928 jbassin@hecvsante.ch
Sub-Investigator: Jean-Philippe Bassin, physiothera.
Sub-Investigator: Damien Currat, physiothera.
Sub-Investigator: Tanniger Sébastien, Engineer

Sponsors and Collaborators

Haute Ecole Cantonale Vaudoise de Santé

University of Applied Sciences of Western Switzerland

University of Lausanne Hospitals

Investigators

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

More Information

Responsible Party:	HECVSanté (University of Applied Sciences in Health) ( Claude Pichonnaz/ HES-professor and physiotherapist )
Study ID Numbers:	HECVSante01, SAGE-X 19860
Study First Received:	February 6, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00627770
Health Authority:	Switzerland: Federal Office of Public Health

Keywords provided by Haute Ecole Cantonale Vaudoise de Santé:

Physical Therapy - Therapeutics - Edema
Arthroplasty replacement knee
Treatment outcome

Study placed in the following topic categories:

Signs and Symptoms
Edema

ClinicalTrials.gov processed this record on January 16, 2009