Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:26 AM
Study NCT ID:
NCT07342894
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-06', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Drain Output', 'timeFrame': 'Postoperative days 0-3', 'description': 'Total postoperative Hemovac drain output measured in milliliters following primary total knee arthroplasty.'}], 'secondaryOutcomes': [{'measure': 'Length of Hospital Stay', 'timeFrame': 'Postoperative days 0-discharge', 'description': 'Duration of postoperative hospital stay measured in days.'}, {'measure': 'Postoperative Hemoglobin Change', 'timeFrame': 'Postoperative first 24-48 hours', 'description': 'Change in hemoglobin level from preoperative baseline to postoperative measurement.'}, {'measure': 'Knee Society Score (KSS)', 'timeFrame': 'Postoperative 1 month', 'description': 'Functional outcome assessed using the Knee Society Score.'}, {'measure': 'Postoperative Pain Intensity', 'timeFrame': 'Postoperative 1 month', 'description': 'Pain intensity assessed using the Visual Analog Scale (VAS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis', 'Total Knee Arthroplasty'], 'conditions': ['Knee Osteoarthritis', 'Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether the timing of Hemovac drain removal affects early clinical outcomes after primary total knee arthroplasty (TKA). Hemovac drains are commonly used after TKA to reduce postoperative bleeding and swelling; however, the optimal timing for drain removal remains controversial.\n\nIn this prospective observational cohort study, patients undergoing primary TKA for knee osteoarthritis will be divided into two groups according to routine clinical practice: those whose drain is removed before the first postoperative rehabilitation session and those whose drain is removed after the first rehabilitation session.\n\nThe primary outcomes include the rate of postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain levels and functional outcomes. The results of this study may help optimize postoperative management strategies following total knee arthroplasty.', 'detailedDescription': 'Total knee arthroplasty (TKA) is a widely performed surgical procedure for the treatment of advanced knee osteoarthritis. Postoperative management often includes the use of closed suction drains, such as Hemovac systems, to reduce hematoma formation and wound complications. However, the necessity and optimal timing of drain removal remain subjects of debate.\n\nThis prospective observational cohort study is designed to compare early clinical outcomes associated with two different timings of Hemovac drain removal following primary TKA. Patients who undergo primary TKA at a single tertiary care center will be enrolled prospectively. According to routine postoperative practice, patients will be allocated into two groups: drain removal before the first postoperative rehabilitation session or drain removal after completion of the first rehabilitation session.\n\nAll patients will receive standardized surgical techniques, anesthesia protocols, postoperative care, and rehabilitation programs. Data will be collected prospectively. Primary outcomes include postoperative hemarthrosis, early postoperative complications, and length of hospital stay. Secondary outcomes include postoperative pain intensity and functional outcome measures.\n\nThis study aims to provide evidence to guide clinical decision-making regarding postoperative drain management in patients undergoing total knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult patients diagnosed with knee osteoarthritis who underwent primary total knee arthroplasty at a single tertiary care center. All participants were treated according to standardized surgical and postoperative care protocols and were followed prospectively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Diagnosis of knee osteoarthritis\n* Undergoing primary total knee arthroplasty\n* Provided written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Revision total knee arthroplasty\n* History of inflammatory arthritis\n* Known bleeding disorders or coagulopathy\n* Active infection or periprosthetic joint infection\n* Incomplete clinical data or loss to follow-up'}, 'identificationModule': {'nctId': 'NCT07342894', 'briefTitle': 'Effect of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Effect of Timing of Hemovac Drain Removal on Early Outcomes After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'TABED2-25-1015_TKA_DRAIN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early Drain Removal (Goup 1)', 'description': 'Patients whose Hemovac drain is removed before the first postoperative rehabilitation session as part of routine clinical practice.'}, {'label': 'Late Drain Removal (Group 2)', 'description': 'Patients whose Hemovac drain is removed after completion of the first postoperative rehabilitation session as part of routine clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, specialist', 'investigatorFullName': 'Şahan Güven', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}