Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-02 @ 7:14 AM
Study NCT ID:
NCT05120492
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2021-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2021-11-03', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, mobility and quality of Life', 'timeFrame': '1 year', 'description': 'Knee Injury and Osteoarthritis Outcome Score (KOOS4)'}], 'secondaryOutcomes': [{'measure': 'EuroQol Group 5-Dimension Self Report Questionnaire (EQ-5D)', 'timeFrame': '1 year', 'description': 'assessing quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthroplasty, Replacement, Knee', 'Bariatric Surgery'], 'conditions': ['Knee Osteoarthritis', 'Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'Does weight loss surgery in patients with morbid obesity prior to knee replacement surgery improve outcomes from knee replacement surgery', 'detailedDescription': 'RCT involving patients who have severe knee osteoarthritis and have a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 45 to 60 and are randomly assigned to receive dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (control arm) or sleeve gastrectomy with dietary and lifestyle counseling for 9 to 13 months followed by total knee replacement (treatment arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsevere knee osteoarthritis body-mass index of 45 to 60\n\nExclusion Criteria:\n\nprevious total replacement of the same knee, a need for bilateral total knee replacement, and knee pain during the previous week that the patient rated at higher than 60 mm on a 100-mm visual-analogue scale. Also,prior bariatric or complex foregut surgery, significant cardiovascular, pulmonary, renal, liver, gastrointestinal, psychiatric disorders, pregnancy, malignancy within last 5 years, anemia, coagulopathy requiring anti-coagulation therapy.'}, 'identificationModule': {'nctId': 'NCT05120492', 'acronym': 'OMEOSKO', 'briefTitle': 'Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Optimal Management of Extreme Obesity and Severe Knee Osteoarthritis Feasibility Trial', 'orgStudyIdInfo': {'id': '41155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical weight loss', 'description': 'sleeve gastrectomy + dietary and lifestyle counseling prior to total knee replacement', 'interventionNames': ['Procedure: bariatric surgery followed by total knee replacement']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'dietary and lifestyle counseling prior to total knee replacement'}], 'interventions': [{'name': 'bariatric surgery followed by total knee replacement', 'type': 'PROCEDURE', 'description': 'The only intervention is the randomization of the priority of the 2 procedures.', 'armGroupLabels': ['Surgical weight loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B4E 0H4', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'James Ellsmere, MD', 'role': 'CONTACT', 'email': 'JELLSMER@DAL.CA', 'phone': '902-473-1886'}], 'facility': 'Nova Scotia Health', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}