Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627770
• Other study ID #: HECVSante01
• Secondary ID: SAGE-X 19860
• Status: Completed
• Phase: N/A
• First received: February 6, 2008
• Last updated: January 28, 2009
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: Haute Ecole Cantonale Vaudoise de Santé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• knee replacement surgery

Exclusion Criteria:

• pacemaker

• cardiac defibrillator

• other metallic implant than knee arthroplasty

Study Design

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

Related Conditions & MeSH terms

• Edema

Intervention

Device:
• bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia
edema evaluation using bioimpedance

Locations

Country	Name	City	State
Switzerland	Département de l'Appareil Locomoteur - CHUV	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
Haute Ecole Cantonale Vaudoise de Santé	University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioimpedance ratio right/left		presurgery, 2 and 8 days post surgery	No