Status:
COMPLETED
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Edema
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
18-90 years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03867305
Start Date
July 26 2019
End Date
February 3 2022
Last Update
February 11 2022
Active Locations (1)
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1
Nîmes University Hospital
Nîmes, France, 30029