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

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: Completed
• Conditions: Edema; Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: MOBIDERM

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2019
• Primary Completion (Actual): December 14, 2021
• Study Completion (Actual): February 3, 2022

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Edema
• Other Study ID 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