Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled (MOBŒDEM)
Primary Purpose
Edema, Arthroplasty, Replacement, Knee
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MOBIDERM
Sponsored by
About this trial
This is an interventional other trial for Edema
Eligibility Criteria
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.
Sites / Locations
- Nîmes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MOBIDERM group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Knee volume
unit: mm3
Knee volume
unit: mm3
Knee volume
unit: mm3
Knee volume
unit: mm3
Knee volume
unit: mm3
Knee volume
unit: mm3
Secondary Outcome Measures
visual analog pain scale visual analog pain scale
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
visual analog pain scale visual analog pain scale
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
visual analog pain scale visual analog pain scale
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
visual analog pain scale visual analog pain scale
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
visual analog pain scale visual analog pain scale
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Knee injury and Osteoarthritis Outcome (KOOS) score
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.
Knee injury and Osteoarthritis Outcome (KOOS) score
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.
Knee injury and Osteoarthritis Outcome (KOOS) score
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.
Measurement of knee flexion / extension
degree
Measurement of knee flexion / extension
degree
Measurement of knee flexion / extension
degree
Measurement of knee flexion / extension
degree
Measurement of knee flexion / extension
degree
Presence of an ecchymosis in proximity to the scar
Yes/no
Presence of an ecchymosis in proximity to the scar
Yes/no
Presence of an ecchymosis in proximity to the scar
Yes/no
Coloration of ecchymosis in proximity to the scar
Qualitative: red, pink, blue, purple, green, brown or yellow
Coloration of ecchymosis in proximity to the scar
Qualitative: red, pink, blue, purple, green, brown or yellow
Coloration of ecchymosis in proximity to the scar
Qualitative: red, pink, blue, purple, green, brown or yellow
Surface area of ecchymosis in proximity to the scar
Traced on OpSite Flexigrid® film: cm2
Surface area of ecchymosis in proximity to the scar
Traced on OpSite Flexigrid® film: cm2
Surface area of ecchymosis in proximity to the scar
Traced on OpSite Flexigrid® film: cm2
Resolution of the ecchymosis in proximity to the scar
Patient and Observer Scar Assessment Scale (observer + patient)
Resolution of the ecchymosis in proximity to the scar
Patient and Observer Scar Assessment Scale (observer + patient)
Resolution of the ecchymosis in proximity to the scar
Patient and Observer Scar Assessment Scale (observer + patient)
Full Information
NCT ID
NCT03867305
First Posted
March 6, 2019
Last Updated
February 10, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03867305
Brief Title
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled
Acronym
MOBŒDEM
Official Title
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
February 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema, Arthroplasty, Replacement, Knee
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MOBIDERM group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
MOBIDERM
Intervention Description
Use of a MOBIDERM mobilizing band after total knee prosthesis
Primary Outcome Measure Information:
Title
Knee volume
Description
unit: mm3
Time Frame
Day -1
Title
Knee volume
Description
unit: mm3
Time Frame
Day 0
Title
Knee volume
Description
unit: mm3
Time Frame
Day 1
Title
Knee volume
Description
unit: mm3
Time Frame
Day 5
Title
Knee volume
Description
unit: mm3
Time Frame
Day 15
Title
Knee volume
Description
unit: mm3
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
visual analog pain scale visual analog pain scale
Description
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Time Frame
Day 1
Title
visual analog pain scale visual analog pain scale
Description
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Time Frame
Day 3
Title
visual analog pain scale visual analog pain scale
Description
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Time Frame
Day 5
Title
visual analog pain scale visual analog pain scale
Description
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Time Frame
Day 15
Title
visual analog pain scale visual analog pain scale
Description
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Time Frame
Month 1
Title
Knee injury and Osteoarthritis Outcome (KOOS) score
Description
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.
Time Frame
day -1
Title
Knee injury and Osteoarthritis Outcome (KOOS) score
Description
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.
Time Frame
day 15
Title
Knee injury and Osteoarthritis Outcome (KOOS) score
Description
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.
Time Frame
month 1
Title
Measurement of knee flexion / extension
Description
degree
Time Frame
Day -1
Title
Measurement of knee flexion / extension
Description
degree
Time Frame
Day 0
Title
Measurement of knee flexion / extension
Description
degree
Time Frame
Day 5
Title
Measurement of knee flexion / extension
Description
degree
Time Frame
Day 15
Title
Measurement of knee flexion / extension
Description
degree
Time Frame
Month 1
Title
Presence of an ecchymosis in proximity to the scar
Description
Yes/no
Time Frame
Day 5
Title
Presence of an ecchymosis in proximity to the scar
Description
Yes/no
Time Frame
Day 15
Title
Presence of an ecchymosis in proximity to the scar
Description
Yes/no
Time Frame
Month 1
Title
Coloration of ecchymosis in proximity to the scar
Description
Qualitative: red, pink, blue, purple, green, brown or yellow
Time Frame
Day 5
Title
Coloration of ecchymosis in proximity to the scar
Description
Qualitative: red, pink, blue, purple, green, brown or yellow
Time Frame
Day 15
Title
Coloration of ecchymosis in proximity to the scar
Description
Qualitative: red, pink, blue, purple, green, brown or yellow
Time Frame
Month 1
Title
Surface area of ecchymosis in proximity to the scar
Description
Traced on OpSite Flexigrid® film: cm2
Time Frame
Day 5
Title
Surface area of ecchymosis in proximity to the scar
Description
Traced on OpSite Flexigrid® film: cm2
Time Frame
Day 15
Title
Surface area of ecchymosis in proximity to the scar
Description
Traced on OpSite Flexigrid® film: cm2
Time Frame
Month 1
Title
Resolution of the ecchymosis in proximity to the scar
Description
Patient and Observer Scar Assessment Scale (observer + patient)
Time Frame
Day 5
Title
Resolution of the ecchymosis in proximity to the scar
Description
Patient and Observer Scar Assessment Scale (observer + patient)
Time Frame
Day 15
Title
Resolution of the ecchymosis in proximity to the scar
Description
Patient and Observer Scar Assessment Scale (observer + patient)
Time Frame
Month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nîmes University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled
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