Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT01924403
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2013-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-13', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-08-14', 'lastUpdatePostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perfusion of Wound Closure', 'timeFrame': 'Surgical Point of Care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TKA', 'Wound Closure', 'Wound Perfusion'], 'conditions': ['Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '25733009', 'type': 'DERIVED', 'citation': 'Wyles CC, Jacobson SR, Houdek MT, Larson DR, Taunton MJ, Sim FH, Sierra RJ, Trousdale RT. The Chitranjan Ranawat Award: Running Subcuticular Closure Enables the Most Robust Perfusion After TKA: A Randomized Clinical Trial. Clin Orthop Relat Res. 2016 Jan;474(1):47-56. doi: 10.1007/s11999-015-4209-x.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old\n* Primary diagnosis of osteoarthritis\n* Surgical indication for index total knee arthroplasty\n\nExclusion Criteria:\n\n* Previous surgery about the knee\n* Systemic corticosteroid use\n* Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis'}, 'identificationModule': {'nctId': 'NCT01924403', 'briefTitle': 'Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty Using SPY Intra-operative Angiography', 'orgStudyIdInfo': {'id': '13-005083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Staple Closure', 'description': 'Staple closure will be one technique employed to close the wound in primary total knee arthroplasty.', 'interventionNames': ['Procedure: Staple Closure']}, {'type': 'EXPERIMENTAL', 'label': 'Running Subcuticular Closure', 'description': 'Running subcuticular closure will be one technique employed to close the wound in primary total knee arthroplasty.', 'interventionNames': ['Procedure: Running Subcuticular Closure']}, {'type': 'EXPERIMENTAL', 'label': 'Vertical Mattress Closure', 'description': 'Vertical mattress closure will be one technique employed to close the wound in primary total knee arthroplasty.', 'interventionNames': ['Procedure: Vertical Mattress Closure']}], 'interventions': [{'name': 'Staple Closure', 'type': 'PROCEDURE', 'armGroupLabels': ['Staple Closure']}, {'name': 'Vertical Mattress Closure', 'type': 'PROCEDURE', 'armGroupLabels': ['Vertical Mattress Closure']}, {'name': 'Running Subcuticular Closure', 'type': 'PROCEDURE', 'armGroupLabels': ['Running Subcuticular Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Robert Trousdale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopedic Surgery', 'investigatorFullName': 'Robert T. Trousdale', 'investigatorAffiliation': 'Mayo Clinic'}}}}