Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT03995160
Status:
UNKNOWN
Last Update Posted:
2021-10-06
First Post:
2019-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Closed Suction Drainage After Total Knee Replacement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006406', 'term': 'Hematoma'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2019-06-20', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in haematocrite levels', 'timeFrame': 'from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively', 'description': 'Measuring results of haematocrite (in percentage in 1 ml of blood sample)'}, {'measure': 'Change in the number of blood transfusions', 'timeFrame': 'from baseline to the 1-,2-,3- days postoperatively', 'description': 'Measuring the number of needed transfusion of packed red blood cells in the postoperative period'}, {'measure': 'Change in levels of inflammation factors', 'timeFrame': 'from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively', 'description': 'Measuring the level of C-reactive protein'}, {'measure': 'Change in haemoglobin levels', 'timeFrame': 'from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively', 'description': 'Measuring results of haemoglobin (g/dL)'}, {'measure': 'Change in erythrocytes levels', 'timeFrame': 'from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively', 'description': 'Measuring results of erythrocytes (number/ml)'}, {'measure': 'Change in platelets levels', 'timeFrame': 'from baseline (can be measured anytime to a maximum of one month before surgery) to 1-day, 3,6 and 12 months post-operatively', 'description': 'Measuring results of platelets (number/ml)'}], 'secondaryOutcomes': [{'measure': 'Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score from baseline', 'timeFrame': 'from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively', 'description': 'The WOMAC Pain score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Pain scores range from 0-100 with lower scores considered lower pain.'}, {'measure': 'Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score from baseline', 'timeFrame': 'from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively', 'description': 'The WOMAC Function score is derived from a sub-section of the Knee injury and Osteoarthritis Outcome Score (KOOS) Knee Survey. The WOMAC Function scores range from 0-100 with lower scores considered to have better function.'}, {'measure': 'Change in body temperature', 'timeFrame': 'from baseline to the 1-,2-,3- days postoperatively', 'description': 'Measuring body temperature from day of the surgery to the hospital until the day of discharge from the hospital'}, {'measure': 'Influence of using CSD on costs of hospitalization', 'timeFrame': 'from baseline to the one year postoperatively', 'description': 'Comparing cost of hospitalization between two analyzed groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total', 'knee', 'arthroplasty', 'tkr', 'drainage', 'haematoma'], 'conditions': ['Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'The aim of the study will be to compare functional outcomes, basic morphology results, number of blood transfusions, costs of hospitalization, and inflammation factors, following total knee replacement (with use of one type of endoprosthesis) comparing use of closed suction drainage (CSD). Use of closed suction drainage may have influence on patients functional outcome.', 'detailedDescription': 'Patients with primary knee osteoarthritis will be included in a randomized controlled trial and assigned to total knee arthroplasty with or without closed suction drainage. Subjects will be evaluated preoperatively, 1-day, 3-, 6- and 12-month postoperatively.\n\nChange in morphology results will be measured by comparing preoperative and postoperative levels of haematocrite, haemoglobin, erythrocytes, and platelets.\n\nChange in the number of blood transfusions will be measured by analyzing the number of needed transfusion of packed red blood cells in the postoperative period during stay in the hospital.\n\nChange in levels of inflammation factors will be measured by analyzing the level of C-reactive protein in first and third day postoperatively.\n\nChange in body temperature wille be measured daily by analyzing body temperature from day of the surgery until the day of discharge from the hospital\n\nPresence of haematoma will be evaluated daily in the postoperative period by clinical examination.\n\nChange in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively\n\nChange in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Function Score will be measured from baseline (can be measured anytime to a maximum of one month before surgery) 3,6 and 12 months post-operatively\n\nCosts of hospitalization will be measured by comparing cost of hospitalization between two analyzed groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient's consent for anticipation in the study\n* arthroplasty in one knee\n\nExclusion Criteria:\n\n* patient's lack of consent for anticipation in the study\n* haematological diseases\n* reoperations in the area of endoprosthesis\n* medical history of any surgical intervention on the lower limb"}, 'identificationModule': {'nctId': 'NCT03995160', 'acronym': 'TKR', 'briefTitle': 'Influence of Closed Suction Drainage After Total Knee Replacement.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': "Influence of Closed Suction Drainage After Total Knee Replacement on Patient's Reported Outcome and Basic Morphology Results, and Inflammation Factors", 'orgStudyIdInfo': {'id': 'TKR/ Warsaw MU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total knee replacement with use of closed suction drainage', 'description': 'Use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis', 'interventionNames': ['Procedure: Use of closed suction drainage following total knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total knee replacement without use of closed suction drainage', 'description': 'Without the use of closed suction drainage following total knee replacement in treatment of knee primary osteoarthritis', 'interventionNames': ['Procedure: Abstain of using a closed suction drainage']}], 'interventions': [{'name': 'Use of closed suction drainage following total knee arthroplasty', 'type': 'PROCEDURE', 'otherNames': ["Redon's drain"], 'description': 'Use of closed suction drainage following total knee arthroplasty', 'armGroupLabels': ['Total knee replacement with use of closed suction drainage']}, {'name': 'Abstain of using a closed suction drainage', 'type': 'PROCEDURE', 'description': 'Abstain of using a closed suction drainage following total knee arthroplasty', 'armGroupLabels': ['Total knee replacement without use of closed suction drainage']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bartosz Maciąg', 'role': 'CONTACT', 'email': 'bartosz.maciag94@gmail.com', 'phone': '+48 881568144'}, {'name': 'Marcin Wojewodzki', 'role': 'CONTACT', 'email': 'dlamarcinawoj@gmail.com', 'phone': '+48 60446187'}], 'overallOfficials': [{'name': 'Artur Stolarczyk, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Warsaw'}, {'name': 'Marcin Wojewodzki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Orthopaedics and Rehabilitation, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Artur Stolarczyk', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}