Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

• Sponsor: Haute Ecole de Santé Vaud (Other)
• Overall Status: Completed
• CT.gov ID: NCT00627770
• Collaborator: University of Applied Sciences of Western Switzerland (Other), University of Lausanne Hospitals (Other)
• Enrollment: 34
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 3.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Edema	Device: bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Outcome Measures

Primary Outcome Measures

1. bioimpedance ratio right/left [presurgery, 2 and 8 days post surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• knee replacement surgery

Exclusion Criteria:

• pacemaker

• cardiac defibrillator

• other metallic implant than knee arthroplasty

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Département de l'Appareil Locomoteur - CHUV	Lausanne		Switzerland	1005

Sponsors and Collaborators

• Haute Ecole de Santé Vaud
• University of Applied Sciences of Western Switzerland
• University of Lausanne Hospitals

Investigators

• Principal Investigator: Claude A Pichonnaz, physiother., Haute Ecole de Santé Vaud
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00627770
• Other Study ID Numbers: HECVSante01; SAGE-X 19860
• First Posted: Mar 3, 2008
• Last Update Posted: Jan 29, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Physical Therapy - Therapeutics - Edema; Arthroplasty replacement knee; Treatment outcome
• Additional relevant MeSH terms: Edema

Study Results

No Results Posted as of Jan 29, 2009