MOBŒDEM: Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled
Study Details
Study Description
Brief Summary
We hypothesize that the use of MOBIDERM® after total knee prosthesis allows a greater and faster resorption of periarticular edema:
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improvement of knee flexion;
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faster functional gain;
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faster decrease in postoperative pain by decreasing tissue tension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MOBIDERM group
|
Device: MOBIDERM
Use of a MOBIDERM mobilizing band after total knee prosthesis
|
| No Intervention: Control group
|
Outcome Measures
Primary Outcome Measures
- Knee volume [Day -1]
unit: mm3
- Knee volume [Day 0]
unit: mm3
- Knee volume [Day 1]
unit: mm3
- Knee volume [Day 5]
unit: mm3
- Knee volume [Day 15]
unit: mm3
- Knee volume [Month 1]
unit: mm3
Secondary Outcome Measures
- visual analog pain scale visual analog pain scale [Day 1]
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
- visual analog pain scale visual analog pain scale [Day 3]
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
- visual analog pain scale visual analog pain scale [Day 5]
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
- visual analog pain scale visual analog pain scale [Day 15]
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
- visual analog pain scale visual analog pain scale [Month 1]
visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt
- Knee injury and Osteoarthritis Outcome (KOOS) score [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.
- Knee injury and Osteoarthritis Outcome (KOOS) score [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.
- Knee injury and Osteoarthritis Outcome (KOOS) score [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.
- Measurement of knee flexion / extension [Day -1]
degree
- Measurement of knee flexion / extension [Day 0]
degree
- Measurement of knee flexion / extension [Day 5]
degree
- Measurement of knee flexion / extension [Day 15]
degree
- Measurement of knee flexion / extension [Month 1]
degree
- Presence of an ecchymosis in proximity to the scar [Day 5]
Yes/no
- Presence of an ecchymosis in proximity to the scar [Day 15]
Yes/no
- Presence of an ecchymosis in proximity to the scar [Month 1]
Yes/no
- Coloration of ecchymosis in proximity to the scar [Day 5]
Qualitative: red, pink, blue, purple, green, brown or yellow
- Coloration of ecchymosis in proximity to the scar [Day 15]
Qualitative: red, pink, blue, purple, green, brown or yellow
- Coloration of ecchymosis in proximity to the scar [Month 1]
Qualitative: red, pink, blue, purple, green, brown or yellow
- Surface area of ecchymosis in proximity to the scar [Day 5]
Traced on OpSite Flexigrid® film: cm2
- Surface area of ecchymosis in proximity to the scar [Day 15]
Traced on OpSite Flexigrid® film: cm2
- Surface area of ecchymosis in proximity to the scar [Month 1]
Traced on OpSite Flexigrid® film: cm2
- Resolution of the ecchymosis in proximity to the scar [Day 5]
Patient and Observer Scar Assessment Scale (observer + patient)
- Resolution of the ecchymosis in proximity to the scar [Day 15]
Patient and Observer Scar Assessment Scale (observer + patient)
- Resolution of the ecchymosis in proximity to the scar [Month 1]
Patient and Observer Scar Assessment Scale (observer + patient)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient requiring a first total knee prosthesis (scheduled between Tuesday and Friday).
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Patient that has given his/her free and informed consent and signed the consent form.
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The patient must be a member or beneficiary of a health insurance plan
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The patient is at least 18 years old (≥) and under 90 years old (<).
Exclusion Criteria:
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The subject is in a period of exclusion determined by a previous study (therapeutic study)
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The subject refuses to sign the consent
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It is impossible to give the subject informed information
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The patient is under safeguard of justice or state guardianship
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The patient is pregnant or breastfeeding
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The patient is allergic to latex bandages.
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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).
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The subject has chronic or active wounds or any cause that hinders normal rehabilitation or the application of a bandage.
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patient with a stroke / Disabling Neurological Pathology, Chronic Immunological Pathology / Systemic Disease.
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patient with Hepatic insufficiency.
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patient with Venous insufficiency (stages 3 and 4).
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The patient is on dialysis.
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The subject has cognitive or behavioral disorders (Parkinson's disease, cerebellar syndrome, opposition, agitation, dementia).
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The subject has a history of knee surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nîmes University Hospital | Nîmes | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IDIL/2017/SP-01