Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled (MOBŒDEM)

February 10, 2022 updated by: Centre Hospitalier Universitaire de Nīmes

Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled Pilot Study

We hypothesize that the use of MOBIDERM® after total knee prosthesis allows a greater and faster resorption of periarticular edema:

  • improvement of knee flexion;
  • faster functional gain;
  • faster decrease in postoperative pain by decreasing tissue tension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • Nîmes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient requiring a first total knee prosthesis (scheduled between Tuesday and Friday).
  • Patient that has given his/her free and informed consent and signed the consent form.
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old (≥) and under 90 years old (<).

Exclusion Criteria:

  • The subject is in a period of exclusion determined by a previous study (therapeutic study)
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • The patient is allergic to latex bandages.
  • The subject has contralateral amputation, pressure ulcers, severe Obstructive Arteriopathy of Lower Limbs, lymphoedema or thromboembolic event of the lower limb (ipsilateral and / or contralateral / superficial or deep or detected by postoperative Doppler).
  • The subject has chronic or active wounds or any cause that hinders normal rehabilitation or the application of a bandage.
  • patient with a stroke / Disabling Neurological Pathology, Chronic Immunological Pathology / Systemic Disease.
  • patient with Hepatic insufficiency.
  • patient with Venous insufficiency (stages 3 and 4).
  • The patient is on dialysis.
  • The subject has cognitive or behavioral disorders (Parkinson's disease, cerebellar syndrome, opposition, agitation, dementia).
  • The subject has a history of knee surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: MOBIDERM group
Device: MOBIDERM
Use of a MOBIDERM mobilizing band after total knee prosthesis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee volume
Time Frame: Day -1
unit: mm3
Day -1
Knee volume
Time Frame: Day 0
unit: mm3
Day 0
Knee volume
Time Frame: Day 1
unit: mm3
Day 1
Knee volume
Time Frame: Day 5
unit: mm3
Day 5
Knee volume
Time Frame: Day 15
unit: mm3
Day 15
Knee volume
Time Frame: Month 1
unit: mm3
Month 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
visual analog pain scale visual analog pain scale
Time Frame: Day 1
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Day 1
visual analog pain scale visual analog pain scale
Time Frame: Day 3
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Day 3
visual analog pain scale visual analog pain scale
Time Frame: Day 5
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Day 5
visual analog pain scale visual analog pain scale
Time Frame: Day 15
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Day 15
visual analog pain scale visual analog pain scale
Time Frame: Month 1
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Month 1
Knee injury and Osteoarthritis Outcome (KOOS) score
Time Frame: day -1
The Knee injury and Osteoarthritis Outcome Score (KOOS) is an instrument for measuring patient-reported outcomes. It assesses short-term and long-term consequences of knee injuries and consequences of primary osteoarthritis.The KOOS has 42 elements grouped into five distinct subscales: KOOS Pain ; KOOS Symptoms; KOOS Function, daily life; KOOS Activities, sports and recreation; KOOS quality of life. The KOOS score is a percentage from 0 to 100, with 0 representing extreme problems and 100 representing no problem.
day -1
Knee injury and Osteoarthritis Outcome (KOOS) score
Time Frame: day 15
The Knee injury and Osteoarthritis Outcome Score (KOOS) is an instrument for measuring patient-reported outcomes. It assesses short-term and long-term consequences of knee injuries and consequences of primary osteoarthritis.The KOOS has 42 elements grouped into five distinct subscales: KOOS Pain ; KOOS Symptoms; KOOS Function, daily life; KOOS Activities, sports and recreation; KOOS quality of life. The KOOS score is a percentage from 0 to 100, with 0 representing extreme problems and 100 representing no problem.
day 15
Knee injury and Osteoarthritis Outcome (KOOS) score
Time Frame: month 1
The Knee injury and Osteoarthritis Outcome Score (KOOS) is an instrument for measuring patient-reported outcomes. It assesses short-term and long-term consequences of knee injuries and consequences of primary osteoarthritis.The KOOS has 42 elements grouped into five distinct subscales: KOOS Pain ; KOOS Symptoms; KOOS Function, daily life; KOOS Activities, sports and recreation; KOOS quality of life. The KOOS score is a percentage from 0 to 100, with 0 representing extreme problems and 100 representing no problem.
month 1
Measurement of knee flexion / extension
Time Frame: Day -1
degree
Day -1
Measurement of knee flexion / extension
Time Frame: Day 0
degree
Day 0
Measurement of knee flexion / extension
Time Frame: Day 5
degree
Day 5
Measurement of knee flexion / extension
Time Frame: Day 15
degree
Day 15
Measurement of knee flexion / extension
Time Frame: Month 1
degree
Month 1
Presence of an ecchymosis in proximity to the scar
Time Frame: Day 5
Yes/no
Day 5
Presence of an ecchymosis in proximity to the scar
Time Frame: Day 15
Yes/no
Day 15
Presence of an ecchymosis in proximity to the scar
Time Frame: Month 1
Yes/no
Month 1
Coloration of ecchymosis in proximity to the scar
Time Frame: Day 5
Qualitative: red, pink, blue, purple, green, brown or yellow
Day 5
Coloration of ecchymosis in proximity to the scar
Time Frame: Day 15
Qualitative: red, pink, blue, purple, green, brown or yellow
Day 15
Coloration of ecchymosis in proximity to the scar
Time Frame: Month 1
Qualitative: red, pink, blue, purple, green, brown or yellow
Month 1
Surface area of ecchymosis in proximity to the scar
Time Frame: Day 5
Traced on OpSite Flexigrid® film: cm2
Day 5
Surface area of ecchymosis in proximity to the scar
Time Frame: Day 15
Traced on OpSite Flexigrid® film: cm2
Day 15
Surface area of ecchymosis in proximity to the scar
Time Frame: Month 1
Traced on OpSite Flexigrid® film: cm2
Month 1
Resolution of the ecchymosis in proximity to the scar
Time Frame: Day 5
Patient and Observer Scar Assessment Scale (observer + patient)
Day 5
Resolution of the ecchymosis in proximity to the scar
Time Frame: Day 15
Patient and Observer Scar Assessment Scale (observer + patient)
Day 15
Resolution of the ecchymosis in proximity to the scar
Time Frame: Month 1
Patient and Observer Scar Assessment Scale (observer + patient)
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDIL/2017/SP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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