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

Arthroplasty, Replacement, Knee Clinical Trial

— MOBŒDEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867305
• Other study ID #: IDIL/2017/SP-01
• Status: Completed
• Phase: N/A
• Start date: July 26, 2019
• Est. completion date: February 3, 2022

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 3, 2022
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Edema

Intervention

Device:
• MOBIDERM
Use of a MOBIDERM mobilizing band after total knee prosthesis

Locations

Country	Name	City	State
France	Nîmes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee volume	unit: mm3	Day -1
Primary	Knee volume	unit: mm3	Day 0
Primary	Knee volume	unit: mm3	Day 1
Primary	Knee volume	unit: mm3	Day 5
Primary	Knee volume	unit: mm3	Day 15
Primary	Knee volume	unit: mm3	Month 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Measurement of knee flexion / extension	degree	Day -1
Secondary	Measurement of knee flexion / extension	degree	Day 0
Secondary	Measurement of knee flexion / extension	degree	Day 5
Secondary	Measurement of knee flexion / extension	degree	Day 15
Secondary	Measurement of knee flexion / extension	degree	Month 1
Secondary	Presence of an ecchymosis in proximity to the scar	Yes/no	Day 5
Secondary	Presence of an ecchymosis in proximity to the scar	Yes/no	Day 15
Secondary	Presence of an ecchymosis in proximity to the scar	Yes/no	Month 1
Secondary	Coloration of ecchymosis in proximity to the scar	Qualitative: red, pink, blue, purple, green, brown or yellow	Day 5
Secondary	Coloration of ecchymosis in proximity to the scar	Qualitative: red, pink, blue, purple, green, brown or yellow	Day 15
Secondary	Coloration of ecchymosis in proximity to the scar	Qualitative: red, pink, blue, purple, green, brown or yellow	Month 1
Secondary	Surface area of ecchymosis in proximity to the scar	Traced on OpSite Flexigrid® film: cm2	Day 5
Secondary	Surface area of ecchymosis in proximity to the scar	Traced on OpSite Flexigrid® film: cm2	Day 15
Secondary	Surface area of ecchymosis in proximity to the scar	Traced on OpSite Flexigrid® film: cm2	Month 1
Secondary	Resolution of the ecchymosis in proximity to the scar	Patient and Observer Scar Assessment Scale (observer + patient)	Day 5
Secondary	Resolution of the ecchymosis in proximity to the scar	Patient and Observer Scar Assessment Scale (observer + patient)	Day 15
Secondary	Resolution of the ecchymosis in proximity to the scar	Patient and Observer Scar Assessment Scale (observer + patient)	Month 1