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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Edema; Arthroplasty, Replacement, Knee

Treatments: Device: MOBIDERM

Study type: Interventional

Funder types: Other

Identifiers

NCT03867305

IDIL/2017/SP-01

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

MOBIDERM group

Experimental group

Treatment:

Device: MOBIDERM

Control group

No Intervention group