Clinical trial NCT03867305: Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled
Official title: Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Arthroplasty, Replacement, Knee
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Knee volume
timeFrame: Day -1
measure: Knee volume
timeFrame: Day 0
measure: Knee volume
timeFrame: Day 1
measure: Knee volume
timeFrame: Day 5
measure: Knee volume
timeFrame: Day 15
measure: Knee volume
timeFrame: Month 1
Secondary outcomes:
measure: visual analog pain scale visual analog pain scale
timeFrame: Day 1
measure: visual analog pain scale visual analog pain scale
timeFrame: Day 3
measure: visual analog pain scale visual analog pain scale
timeFrame: Day 5
measure: visual analog pain scale visual analog pain scale
timeFrame: Day 15
measure: visual analog pain scale visual analog pain scale
timeFrame: Month 1
measure: Knee injury and Osteoarthritis Outcome (KOOS) score
timeFrame: day -1
measure: Knee injury and Osteoarthritis Outcome (KOOS) score
timeFrame: day 15
measure: Knee injury and Osteoarthritis Outcome (KOOS) score
timeFrame: month 1
measure: Measurement of knee flexion / extension
timeFrame: Day -1
measure: Measurement of knee flexion / extension
timeFrame: Day 0
measure: Measurement of knee flexion / extension
timeFrame: Day 5
measure: Measurement of knee flexion / extension
timeFrame: Day 15
measure: Measurement of knee flexion / extension
timeFrame: Month 1
measure: Presence of an ecchymosis in proximity to the scar
timeFrame: Day 5
measure: Presence of an ecchymosis in proximity to the scar
timeFrame: Day 15
measure: Presence of an ecchymosis in proximity to the scar
timeFrame: Month 1
measure: Coloration of ecchymosis in proximity to the scar
timeFrame: Day 5
measure: Coloration of ecchymosis in proximity to the scar
timeFrame: Day 15
measure: Coloration of ecchymosis in proximity to the scar
timeFrame: Month 1
measure: Surface area of ecchymosis in proximity to the scar
timeFrame: Day 5
measure: Surface area of ecchymosis in proximity to the scar
timeFrame: Day 15
measure: Surface area of ecchymosis in proximity to the scar
timeFrame: Month 1
measure: Resolution of the ecchymosis in proximity to the scar
timeFrame: Day 5
measure: Resolution of the ecchymosis in proximity to the scar
timeFrame: Day 15
measure: Resolution of the ecchymosis in proximity to the scar
timeFrame: Month 1
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Nîmes University Hospital
Study officials:
References: