Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT03867305
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2019-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2019-03-06', 'studyFirstSubmitQcDate': '2019-03-06', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee volume', 'timeFrame': 'Day -1', 'description': 'unit: mm3'}, {'measure': 'Knee volume', 'timeFrame': 'Day 0', 'description': 'unit: mm3'}, {'measure': 'Knee volume', 'timeFrame': 'Day 1', 'description': 'unit: mm3'}, {'measure': 'Knee volume', 'timeFrame': 'Day 5', 'description': 'unit: mm3'}, {'measure': 'Knee volume', 'timeFrame': 'Day 15', 'description': 'unit: mm3'}, {'measure': 'Knee volume', 'timeFrame': 'Month 1', 'description': 'unit: mm3'}], 'secondaryOutcomes': [{'measure': 'visual analog pain scale visual analog pain scale', 'timeFrame': 'Day 1', 'description': 'visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt'}, {'measure': 'visual analog pain scale visual analog pain scale', 'timeFrame': 'Day 3', 'description': 'visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt'}, {'measure': 'visual analog pain scale visual analog pain scale', 'timeFrame': 'Day 5', 'description': 'visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt'}, {'measure': 'visual analog pain scale visual analog pain scale', 'timeFrame': 'Day 15', 'description': 'visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt'}, {'measure': 'visual analog pain scale visual analog pain scale', 'timeFrame': 'Month 1', 'description': 'visual scale numbered from 0 to 10 allowing patients to indicate the level of pain felt'}, {'measure': 'Knee injury and Osteoarthritis Outcome (KOOS) score', 'timeFrame': 'day -1', 'description': '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.'}, {'measure': 'Knee injury and Osteoarthritis Outcome (KOOS) score', 'timeFrame': 'day 15', 'description': '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.'}, {'measure': 'Knee injury and Osteoarthritis Outcome (KOOS) score', 'timeFrame': 'month 1', 'description': '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.'}, {'measure': 'Measurement of knee flexion / extension', 'timeFrame': 'Day -1', 'description': 'degree'}, {'measure': 'Measurement of knee flexion / extension', 'timeFrame': 'Day 0', 'description': 'degree'}, {'measure': 'Measurement of knee flexion / extension', 'timeFrame': 'Day 5', 'description': 'degree'}, {'measure': 'Measurement of knee flexion / extension', 'timeFrame': 'Day 15', 'description': 'degree'}, {'measure': 'Measurement of knee flexion / extension', 'timeFrame': 'Month 1', 'description': 'degree'}, {'measure': 'Presence of an ecchymosis in proximity to the scar', 'timeFrame': 'Day 5', 'description': 'Yes/no'}, {'measure': 'Presence of an ecchymosis in proximity to the scar', 'timeFrame': 'Day 15', 'description': 'Yes/no'}, {'measure': 'Presence of an ecchymosis in proximity to the scar', 'timeFrame': 'Month 1', 'description': 'Yes/no'}, {'measure': 'Coloration of ecchymosis in proximity to the scar', 'timeFrame': 'Day 5', 'description': 'Qualitative: red, pink, blue, purple, green, brown or yellow'}, {'measure': 'Coloration of ecchymosis in proximity to the scar', 'timeFrame': 'Day 15', 'description': 'Qualitative: red, pink, blue, purple, green, brown or yellow'}, {'measure': 'Coloration of ecchymosis in proximity to the scar', 'timeFrame': 'Month 1', 'description': 'Qualitative: red, pink, blue, purple, green, brown or yellow'}, {'measure': 'Surface area of ecchymosis in proximity to the scar', 'timeFrame': 'Day 5', 'description': 'Traced on OpSite Flexigrid® film: cm2'}, {'measure': 'Surface area of ecchymosis in proximity to the scar', 'timeFrame': 'Day 15', 'description': 'Traced on OpSite Flexigrid® film: cm2'}, {'measure': 'Surface area of ecchymosis in proximity to the scar', 'timeFrame': 'Month 1', 'description': 'Traced on OpSite Flexigrid® film: cm2'}, {'measure': 'Resolution of the ecchymosis in proximity to the scar', 'timeFrame': 'Day 5', 'description': 'Patient and Observer Scar Assessment Scale (observer + patient)'}, {'measure': 'Resolution of the ecchymosis in proximity to the scar', 'timeFrame': 'Day 15', 'description': 'Patient and Observer Scar Assessment Scale (observer + patient)'}, {'measure': 'Resolution of the ecchymosis in proximity to the scar', 'timeFrame': 'Month 1', 'description': 'Patient and Observer Scar Assessment Scale (observer + patient)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edema', 'Arthroplasty, Replacement, Knee']}, 'descriptionModule': {'briefSummary': 'We hypothesize that the use of MOBIDERM® after total knee prosthesis allows a greater and faster resorption of periarticular edema:\n\n* improvement of knee flexion;\n* faster functional gain;\n* faster decrease in postoperative pain by decreasing tissue tension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient requiring a first total knee prosthesis (scheduled between Tuesday and Friday).\n* Patient that has given his/her free and informed consent and signed the consent form.\n* The patient must be a member or beneficiary of a health insurance plan\n* The patient is at least 18 years old (≥) and under 90 years old (\\<).\n\nExclusion Criteria:\n\n* The subject is in a period of exclusion determined by a previous study (therapeutic study)\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* The patient is pregnant or breastfeeding\n* The patient is allergic to latex bandages.\n* 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).\n* The subject has chronic or active wounds or any cause that hinders normal rehabilitation or the application of a bandage.\n* patient with a stroke / Disabling Neurological Pathology, Chronic Immunological Pathology / Systemic Disease.\n* patient with Hepatic insufficiency.\n* patient with Venous insufficiency (stages 3 and 4).\n* The patient is on dialysis.\n* The subject has cognitive or behavioral disorders (Parkinson's disease, cerebellar syndrome, opposition, agitation, dementia).\n* The subject has a history of knee surgery."}, 'identificationModule': {'nctId': 'NCT03867305', 'acronym': 'MOBŒDEM', 'briefTitle': 'Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'IDIL/2017/SP-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOBIDERM group', 'interventionNames': ['Device: MOBIDERM']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'MOBIDERM', 'type': 'DEVICE', 'description': 'Use of a MOBIDERM mobilizing band after total knee prosthesis', 'armGroupLabels': ['MOBIDERM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'Nîmes University Hospital', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}