Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT05840705
Status:
UNKNOWN
Last Update Posted:
2023-05-03
First Post:
2023-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-06-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-30', 'studyFirstSubmitDate': '2023-01-01', 'studyFirstSubmitQcDate': '2023-04-30', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcomes', 'timeFrame': '3 years', 'description': 'Knee society score'}, {'measure': 'length of skin incision', 'timeFrame': '7 years', 'description': 'lenght of skin incision in centimeters'}, {'measure': 'operative time', 'timeFrame': '7 years', 'description': 'Oprative time in minutes'}], 'secondaryOutcomes': [{'measure': 'revision rate', 'timeFrame': '7 years', 'description': 'no. of patients requiring revision'}, {'measure': 'wound complications', 'timeFrame': '7 years', 'description': 'Any reported wound complications'}, {'measure': 'wound infection', 'timeFrame': '7 years', 'description': 'No of patients with wound infection'}, {'measure': 'Range of motion', 'timeFrame': '7 years', 'description': 'Range of knee flexion and extension in degrees'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total knee arthroplasty', 'obese'], 'conditions': ['Arthropathy', 'Incision, Surgical', 'Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbid obese patients with body mass index more than 45 requiring total knee arthroplasty for any cause\n\nExclusion Criteria:\n\n* candidates not meeting the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05840705', 'briefTitle': 'Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients', 'orgStudyIdInfo': {'id': '54321askay'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total knee arthroplasty', 'interventionNames': ['Procedure: Small curved incision with apex lateral']}], 'interventions': [{'name': 'Small curved incision with apex lateral', 'type': 'PROCEDURE', 'description': 'Small curved incision with apex lateral', 'armGroupLabels': ['Total knee arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Saeed', 'role': 'CONTACT', 'email': 'ahmed.s.younis@med.asu.edu.eg', 'phone': '01012370677'}], 'facility': 'Ahmed Saeed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Saeed', 'role': 'CONTACT', 'email': 'ahmed.s.younis@med.asu.edu.eg', 'phone': '+201012370677'}], 'facility': 'Ahmed Saeed', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of orthopaedics', 'investigatorFullName': 'Ahmed Saeed Younis', 'investigatorAffiliation': 'Ain Shams University'}}}}