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

NCT03867305 | Completed

• 1 other identifier: IDIL/2017/SP-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (6)

• Knee volume

  unit: mm3

  Day -1

• Knee volume

  unit: mm3

  Day 0

• Knee volume

  unit: mm3

  Day 1

• Knee volume

  unit: mm3

  Day 5

• Knee volume

  unit: mm3

  Day 15

• Knee volume

  unit: mm3

  Month 1

Secondary Outcomes (25)

• visual analog pain scale visual analog pain scale

  Day 1

• visual analog pain scale visual analog pain scale

  Day 3

• visual analog pain scale visual analog pain scale

  Day 5

• visual analog pain scale visual analog pain scale

  Day 15

• visual analog pain scale visual analog pain scale

  Month 1

Study Arms (2)

MOBIDERM group

EXPERIMENTAL

Device: MOBIDERM

Control group

NO INTERVENTION

Interventions

MOBIDERM DEVICE

Use of a MOBIDERM mobilizing band after total knee prosthesis

MOBIDERM group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (\<).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nîmes University Hospital

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 7, 2019
• Study Start: July 26, 2019
• Primary Completion: December 14, 2021
• Study Completion: February 3, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

FR (1)