EdemaNCT00627770
Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance
A study testing bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia in people with Edema, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Edema
- What is being tested?
- bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- knee replacement surgery
Who cannot join
- pacemaker
- cardiac defibrillator
- other metallic implant than knee arthroplasty
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Département de l'Appareil Locomoteur - CHUV
Lausanne, 1005
About this study
Official title: Validation of a Procedure Using Bioimpedance to Measure the Edema of Lower Leg of Patients After Total Knee Surgery
The purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty
Read the 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.
- Conditions
- Edema
- Being tested
- bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia
- Keywords
- Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioimpedance spectroscopy ImpediMed SFB7 Brisbane AustraliaDevice
edema evaluation using bioimpedance
What is being measured
The primary outcome is the main question the study is designed to answer.
bioimpedance ratio right/left
Measured: presurgery, 2 and 8 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals
- Investigators
- Claude A Pichonnaz, physiother., Principal investigator, Haute Ecole de Santé VaudBrigitte M Jolles, PhD MER MSc, Study director, Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFLCorrevon Marc, Engineer, Principal investigator, Haute Ecole Vaudoise d'Ingénierie et de Gestion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627770
- Sponsor's protocol ID
- HECVSante01
- Other IDs
- SAGE-X 19860
- Status last verified
- Jan 2009
- First submitted
- 6 Feb 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25907994
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Procedure Using Bioimpedance to Measure the Edema of Lower Leg of Patients After Total Knee Surgery
- ClinicalTrials.gov ID
- NCT00627770
- Acronym / sponsor ID
- HECVSante01
- Conditions
- Edema
- Keywords
- Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland, University of Lausanne Hospitals
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- knee replacement surgery
Key exclusion criteria (3 listed)
- pacemaker
- cardiac defibrillator
- other metallic implant than knee arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australiaedema evaluation using bioimpedance | Device | – |
Primary outcome
bioimpedance ratio right/left
Time frame: presurgery, 2 and 8 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
- Derived from this study: PubMed 25907994Pichonnaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude A Pichonnaz, physiother. principal investigator
Haute Ecole de Santé Vaud
Brigitte M Jolles, PhD MER MSc study director
Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
Correvon Marc, Engineer principal investigator
Haute Ecole Vaudoise d'Ingénierie et de Gestion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia in people with Edema, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bioimpedance ratio right/left (time frame: presurgery, 2 and 8 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2009; AzTrials last refreshed its copy on 28 Oct 2026.