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

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ClinicalTrials.gov Identifier: NCT03867305
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Edema Arthroplasty, Replacement, Knee Device: MOBIDERM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled Pilot Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MOBIDERM group Device: MOBIDERM
Use of a MOBIDERM mobilizing band after total knee prosthesis

No Intervention: Control group



Primary Outcome Measures :
  1. Knee volume [ Time Frame: Day -1 ]
    unit: mm3

  2. Knee volume [ Time Frame: Day 0 ]
    unit: mm3

  3. Knee volume [ Time Frame: Day 1 ]
    unit: mm3

  4. Knee volume [ Time Frame: Day 5 ]
    unit: mm3

  5. Knee volume [ Time Frame: Day 15 ]
    unit: mm3

  6. Knee volume [ Time Frame: Month 1 ]
    unit: mm3


Secondary Outcome Measures :
  1. visual analog pain scale visual analog pain scale [ Time Frame: Day 1 ]
    visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt

  2. visual analog pain scale visual analog pain scale [ Time Frame: Day 3 ]
    visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt

  3. visual analog pain scale visual analog pain scale [ Time Frame: Day 5 ]
    visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt

  4. visual analog pain scale visual analog pain scale [ Time Frame: Day 15 ]
    visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt

  5. visual analog pain scale visual analog pain scale [ Time Frame: Month 1 ]
    visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt

  6. Knee injury and Osteoarthritis Outcome (KOOS) score [ Time Frame: 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.

  7. Knee injury and Osteoarthritis Outcome (KOOS) score [ Time Frame: day 15 ]
    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.

  8. Knee injury and Osteoarthritis Outcome (KOOS) score [ Time Frame: month 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.

  9. Measurement of knee flexion / extension [ Time Frame: Day -1 ]
    degree

  10. Measurement of knee flexion / extension [ Time Frame: Day 0 ]
    degree

  11. Measurement of knee flexion / extension [ Time Frame: Day 5 ]
    degree

  12. Measurement of knee flexion / extension [ Time Frame: Day 15 ]
    degree

  13. Measurement of knee flexion / extension [ Time Frame: Month 1 ]
    degree



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 participating in a another study, or is in a period of exclusion determined by a previous 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867305


Contacts
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Contact: Sylvie Petiot, MD +33(0)4.66.68.39.20 sylvie.petiot@chu-nimes.fr

Locations
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France
Nîmes University Hospital Not yet recruiting
Nîmes, France, 30029
Contact: Anissa MEGZARI, MD    +33(0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Sylvie PETIOT, MD         
Sub-Investigator: Mylène BLOT         
Sub-Investigator: Dominique RICHARD         
Sub-Investigator: Willy FAGART         
Sub-Investigator: Clarisse BELVISI         
Sub-Investigator: Aurélien SAOUIB         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03867305     History of Changes
Other Study ID Numbers: IDIL/2017/SP-01
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Edema
Signs and Symptoms