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Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

Primary Purpose

Edema

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia
Sponsored by
Haute Ecole de Santé Vaud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Edema focused on measuring Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • knee replacement surgery

Exclusion Criteria:

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

Sites / Locations

  • Département de l'Appareil Locomoteur - CHUV

Outcomes

Primary Outcome Measures

bioimpedance ratio right/left

Secondary Outcome Measures

Full Information

First Posted
February 6, 2008
Last Updated
January 28, 2009
Sponsor
Haute Ecole de Santé Vaud
Collaborators
University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00627770
Brief Title
Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance
Official Title
Validation of a Procedure Using Bioimpedance to Measure the Edema of Lower Leg of Patients After Total Knee Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Haute Ecole de Santé Vaud
Collaborators
University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema
Keywords
Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia
Intervention Description
edema evaluation using bioimpedance
Primary Outcome Measure Information:
Title
bioimpedance ratio right/left
Time Frame
presurgery, 2 and 8 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: knee replacement surgery Exclusion Criteria: pacemaker cardiac defibrillator other metallic implant than knee arthroplasty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude A Pichonnaz, physiother.
Organizational Affiliation
Haute Ecole de Santé Vaud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brigitte M Jolles, PhD MER MSc
Organizational Affiliation
Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Correvon Marc, Engineer
Organizational Affiliation
Haute Ecole Vaudoise d'Ingénierie et de Gestion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département de l'Appareil Locomoteur - CHUV
City
Lausanne
ZIP/Postal Code
1005
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25907994
Citation
Pichonnaz C, Bassin JP, Lecureux E, Currat D, Jolles BM. Bioimpedance spectroscopy for swelling evaluation following total knee arthroplasty: a validation study. BMC Musculoskelet Disord. 2015 Apr 25;16:100. doi: 10.1186/s12891-015-0559-5.
Results Reference
derived

Learn more about this trial

Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

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