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

Study Overview
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Brief Summary
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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.

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

Conditions
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Edema, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: MOBIDERM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOBIDERM group<br> | Device: MOBIDERM<br>* Use of a MOBIDERM mobilizing band after total knee prosthesis<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee volume | unit: mm3 | Day -1 | 
| Knee volume | unit: mm3 | Day 0 | 
| Knee volume | unit: mm3 | Day 1 | 
| Knee volume | unit: mm3 | Day 5 | 
| Knee volume | unit: mm3 | Day 15 | 
| Knee volume | unit: mm3 | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog pain scale visual analog pain scale | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | degree | Day -1 | 
| Measurement of knee flexion / extension | degree | Day 0 | 
| Measurement of knee flexion / extension | degree | Day 5 | 
| Measurement of knee flexion / extension | degree | Day 15 | 
| Measurement of knee flexion / extension | degree | Month 1 | 
| Presence of an ecchymosis in proximity to the scar | Yes/no | Day 5 | 
| Presence of an ecchymosis in proximity to the scar | Yes/no | Day 15 | 
| Presence of an ecchymosis in proximity to the scar | Yes/no | Month 1 | 
| Coloration of ecchymosis in proximity to the scar | Qualitative: red, pink, blue, purple, green, brown or yellow | Day 5 | 
| Coloration of ecchymosis in proximity to the scar | Qualitative: red, pink, blue, purple, green, brown or yellow | Day 15 | 
| Coloration of ecchymosis in proximity to the scar | Qualitative: red, pink, blue, purple, green, brown or yellow | Month 1 | 
| Surface area of ecchymosis in proximity to the scar | Traced on OpSite Flexigrid® film: cm2 | Day 5 | 
| Surface area of ecchymosis in proximity to the scar | Traced on OpSite Flexigrid® film: cm2 | Day 15 | 
| Surface area of ecchymosis in proximity to the scar | Traced on OpSite Flexigrid® film: cm2 | Month 1 | 
| Resolution of the ecchymosis in proximity to the scar | Patient and Observer Scar Assessment Scale (observer + patient) | Day 5 | 
| Resolution of the ecchymosis in proximity to the scar | Patient and Observer Scar Assessment Scale (observer + patient) | Day 15 | 
| Resolution of the ecchymosis in proximity to the scar | Patient and Observer Scar Assessment Scale (observer + patient) | Month 1 |