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

Not Applicable

Completed

• Conditions: Edema; Arthroplasty, Replacement, Knee
• Interventions: Device: MOBIDERM

• Registration Number: NCT03867305
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-07
• Study Start: 2019-07-26
• Primary Completion: 2021-12-14
• Status Verified: 2022-02
• Study Completion: 2022-02-03
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOBIDERM group	MOBIDERM	-

Primary Outcome Measures

Name	Time	Method
Knee volume	Month 1	unit: mm3

Secondary Outcome Measures

Name	Time	Method
visual analog pain scale visual analog pain scale	Month 1	visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
Knee injury and Osteoarthritis Outcome (KOOS) score	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.
Measurement of knee flexion / extension	Month 1	degree
Surface area of ecchymosis in proximity to the scar	Month 1	Traced on OpSite Flexigrid® film: cm2
Resolution of the ecchymosis in proximity to the scar	Month 1	Patient and Observer Scar Assessment Scale (observer + patient)
Coloration of ecchymosis in proximity to the scar	Month 1	Qualitative: red, pink, blue, purple, green, brown or yellow
Presence of an ecchymosis in proximity to the scar	Month 1	Yes/no

Trial Locations

Locations (1)

Nîmes University Hospital; 🇫🇷 Nîmes, France