Arthroplasty, Replacement, Knee, Edema
Conditions
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.
Interventions
DEVICEMOBIDERM
Use of a MOBIDERM mobilizing band after total knee prosthesis
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee volume | Day -1 | unit: mm3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee injury and Osteoarthritis Outcome (KOOS) score | day -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 | Day -1 | degree |
| Presence of an ecchymosis in proximity to the scar | Day 5 | Yes/no |
| visual analog pain scale visual analog pain scale | Day 1 | visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt |
| Surface area of ecchymosis in proximity to the scar | Day 5 | Traced on OpSite Flexigrid® film: cm2 |
| Resolution of the ecchymosis in proximity to the scar | Day 5 | Patient and Observer Scar Assessment Scale (observer + patient) |
| Coloration of ecchymosis in proximity to the scar | Day 5 | Qualitative: red, pink, blue, purple, green, brown or yellow |
Countries
France
Outcome results
None listed