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
  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 ImpediMed SFB7 Brisbane Australia

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

Resource links provided by NLM:


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 ]

Enrollment: 34
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Claude Pichonnaz/ HES-professor and physiotherapist, HECVSanté (University of Applied Sciences in Health)
ClinicalTrials.gov Identifier: NCT00627770     History of Changes
Other Study ID Numbers: HECVSante01, SAGE-X 19860
Study First Received: February 6, 2008
Last Updated: January 28, 2009
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

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014