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Completed

NCT Number: NCT03867305

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

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.

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Key information

Conditions

Edema Arthroplasty, Replacement, Knee Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nîmes University Hospital

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MOBIDERM

Device

Use of a MOBIDERM mobilizing band after total knee prosthesis

Primary outcomes

  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 outcomes

  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

  14. Presence of an ecchymosis in proximity to the scar

    Time frame: Day 5

    Yes/no

  15. Presence of an ecchymosis in proximity to the scar

    Time frame: Day 15

    Yes/no

  16. Presence of an ecchymosis in proximity to the scar

    Time frame: Month 1

    Yes/no

  17. Coloration of ecchymosis in proximity to the scar

    Time frame: Day 5

    Qualitative: red, pink, blue, purple, green, brown or yellow

  18. Coloration of ecchymosis in proximity to the scar

    Time frame: Day 15

    Qualitative: red, pink, blue, purple, green, brown or yellow

  19. Coloration of ecchymosis in proximity to the scar

    Time frame: Month 1

    Qualitative: red, pink, blue, purple, green, brown or yellow

  20. Surface area of ecchymosis in proximity to the scar

    Time frame: Day 5

    Traced on OpSite Flexigrid® film: cm2

  21. Surface area of ecchymosis in proximity to the scar

    Time frame: Day 15

    Traced on OpSite Flexigrid® film: cm2

  22. Surface area of ecchymosis in proximity to the scar

    Time frame: Month 1

    Traced on OpSite Flexigrid® film: cm2

  23. Resolution of the ecchymosis in proximity to the scar

    Time frame: Day 5

    Patient and Observer Scar Assessment Scale (observer + patient)

  24. Resolution of the ecchymosis in proximity to the scar

    Time frame: Day 15

    Patient and Observer Scar Assessment Scale (observer + patient)

  25. Resolution of the ecchymosis in proximity to the scar

    Time frame: Month 1

    Patient and Observer Scar Assessment Scale (observer + patient)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: MOBŒDEM

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Mar 7, 2019
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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