NCT00627770

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

10 months

First QC Date

February 6, 2008

Last Update Submit

January 28, 2009

Conditions

Edema

Keywords

Physical Therapy - Therapeutics - EdemaArthroplasty replacement kneeTreatment outcome

Outcome Measures

Primary Outcomes (1)

  • bioimpedance ratio right/left

    presurgery, 2 and 8 days post surgery

Interventions

bioimpedance spectroscopy ImpediMed SFB7 Brisbane AustraliaDEVICE

edema evaluation using bioimpedance

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • knee replacement surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de l'Appareil Locomoteur - CHUV

Lausanne, 1005, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 25907994DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claude A Pichonnaz, physiother.

    Haute Ecole de Santé Vaud

    PRINCIPAL INVESTIGATOR

  • Brigitte M Jolles, PhD MER MSc

    Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL

    STUDY DIRECTOR

  • Correvon Marc, Engineer

    Haute Ecole Vaudoise d'Ingénierie et de Gestion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2008

First Posted

March 3, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

CH(1)