Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-07 @ 1:34 PM
Study NCT ID:
NCT02986061
Status:
UNKNOWN
Last Update Posted:
2016-12-08
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062885', 'term': 'Urinary Catheters'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative urinary retention', 'timeFrame': '7 days'}, {'measure': 'Postoperative urinary tract infection', 'timeFrame': '7 days'}, {'measure': 'Urine volume', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': '14 days'}, {'measure': 'Intraoperative intravenous fluid', 'timeFrame': '1 day'}, {'measure': 'Duration of the surgery', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Urinary Catheter']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate whether urinary catheterization could be avoided for all patients undergoing total knee arthroplasty under combined spinal-epidural analgesia plus multi-site infiltration analgesia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40 years and older, who were scheduled for a primary TKA for end-stage osteoarthritis and those who were willing and able to return for follow-up over at least a 1-month postoperative period.\n\nExclusion Criteria:\n\n* Revisions, bilateral procedures, surgical history of urinary system, urinary tract infection and systematical conditions (renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery) needing intraoperative monitoring urine output.'}, 'identificationModule': {'nctId': 'NCT02986061', 'briefTitle': 'To Catheterize or Not? in Total Knee Arthroplasty With Combined Spinal-epidural Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'orgStudyIdInfo': {'id': 'Knee-UC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients with indwelling urinary catheter', 'interventionNames': ['Device: Urinary catheter']}, {'type': 'NO_INTERVENTION', 'label': 'Study Group', 'description': 'Patients without indwelling urinary catheter'}], 'interventions': [{'name': 'Urinary catheter', 'type': 'DEVICE', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei-Nan Zeng, MD', 'role': 'CONTACT', 'email': 'weinanzeng@163.com'}], 'facility': 'Center for Joint Surgery, Southwest Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Wei-Nan Zeng, MD', 'role': 'CONTACT', 'email': 'weinanzeng@163.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Liu Yang', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}