Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-03-01 @ 1:45 PM
Study NCT ID:
NCT05461651
Status:
RECRUITING
Last Update Posted:
2022-07-18
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infection Prevention After TKA With or Without Vancomycin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2029-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of surgical site infection', 'timeFrame': 'up to 24 months', 'description': 'The incidence of deep and superficial SSI after knee arthroplasty'}], 'secondaryOutcomes': [{'measure': 'Blood test - CRP', 'timeFrame': '12 weeks,', 'description': 'inflammatory reaction - CRP'}, {'measure': 'Blood test - IL 6', 'timeFrame': '12 weeks,', 'description': 'inflammatory reaction - Il-6'}, {'measure': 'Functional tests', 'timeFrame': '12 weeks,', 'description': 'hop-for-distance'}, {'measure': 'Functional tests', 'timeFrame': '6 months,', 'description': 'hop-for-distance'}, {'measure': 'Functional tests', 'timeFrame': '12 months', 'description': 'hop-for-distance'}, {'measure': 'Functional tests', 'timeFrame': '24 months', 'description': 'hop-for-distance'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '6 weeks', 'description': 'Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '6 months', 'description': 'Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '12 months', 'description': 'Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '24 months', 'description': 'Knee Injury and Osteoarthritis Outcome Score; KOOS is intended to be used for knee injury that can result in post traumatic osteoarthritis (OA); KOOS has high test-retest reliability. In patients with knee injury, ICCs for the Pain subscale range from 0.85-0.93, the Symptoms subscale from 0.83-0.95, the ADL subscale from 0.75-0.91, the Sport/Rec subscale from 0.61-0.89 and the QOL subscale from 0.83-0.95. In patients with knee OA, ICCs for the Pain subscale range from 0.8-0.97, the Symptoms subscale from 0.74-0.94, the ADL subscale from 0.84-0.94, the Sport/Rec subscale from 0.65-0.92 and the QOL subscale from 0.6-0.91 (4).'}, {'measure': '36-Item Short Form Survey', 'timeFrame': '6 weeks', 'description': 'Quality of life, pain SF-36'}, {'measure': '36-Item Short Form Survey', 'timeFrame': '6 months', 'description': 'Quality of life, pain SF-36'}, {'measure': '36-Item Short Form Survey', 'timeFrame': '12 months', 'description': 'Quality of life, pain SF-36'}, {'measure': '36-Item Short Form Survey', 'timeFrame': '24 months', 'description': 'Quality of life, pain SF-36'}, {'measure': 'Visual analog Scale', 'timeFrame': '6 weeks', 'description': 'Pain Visual Analog Scale\n\nThe pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)\\[8\\] orientated from the left (worst) to the right (best).'}, {'measure': 'Visual analog Scale', 'timeFrame': '6 months', 'description': 'Pain Visual Analog Scale\n\nThe pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)\\[8\\] orientated from the left (worst) to the right (best).'}, {'measure': 'Visual analog Scale', 'timeFrame': '12 months', 'description': 'Pain Visual Analog Scale\n\nThe pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)\\[8\\] orientated from the left (worst) to the right (best).'}, {'measure': 'Visual analog Scale', 'timeFrame': '24 months', 'description': 'Pain Visual Analog Scale\n\nThe pain VAS is a unidimensional measure of pain intensity. The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health)\\[8\\] orientated from the left (worst) to the right (best).'}, {'measure': 'Tegner Lysholm Knee Scoring Scale', 'timeFrame': '6 weeks', 'description': 'The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).'}, {'measure': 'Tegner Lysholm Knee Scoring Scale', 'timeFrame': '6 months', 'description': 'The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).'}, {'measure': 'Tegner Lysholm Knee Scoring Scale', 'timeFrame': '12 months', 'description': 'The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).'}, {'measure': 'Tegner Lysholm Knee Scoring Scale', 'timeFrame': '24 months', 'description': 'The Lysholm Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TKA, Vancomycin'], 'conditions': ['Infection']}, 'descriptionModule': {'briefSummary': 'Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in prevention of infection after Total Knee Arthroplasty With or Without Vancomycin.', 'detailedDescription': 'Infection after surgery is one of the most common complication after total knee replacement. Our prospective randomized study is intended to show if addition of vancomycin to the joint before the wound closure will decrease infection after operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gosnartrosis\n\nExclusion Criteria:\n\n* no informed consent to participate in the study age under 40 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb ASA score \\> II'}, 'identificationModule': {'nctId': 'NCT05461651', 'acronym': 'TKA_Vanco', 'briefTitle': 'Infection Prevention After TKA With or Without Vancomycin', 'organization': {'class': 'OTHER', 'fullName': 'Centre of Postgraduate Medical Education'}, 'officialTitle': 'Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes in Prevention of Infection After Total Knee Arthroplasty With or Without Vancomycin.', 'orgStudyIdInfo': {'id': 'TKA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Knee arthroplasty', 'description': 'Knee arthroplasty without addition of antibiotic wash oraz antibitiotic powder to the surgery site', 'interventionNames': ['Procedure: Knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Knee arthroplasty + vancomycin', 'description': 'Knee arthroplasty with addition of vancomysin powder to the surgery site', 'interventionNames': ['Procedure: Knee arthroplasty']}], 'interventions': [{'name': 'Knee arthroplasty', 'type': 'PROCEDURE', 'description': 'total or unilateral knee arthroplasty', 'armGroupLabels': ['Knee arthroplasty', 'Knee arthroplasty + vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05-400', 'city': 'Otwock', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Rafal Kaminski, MD PhD', 'role': 'CONTACT', 'email': 'rkaminski@spskgruca.pl', 'phone': '+48227794031', 'phoneExt': '469'}, {'name': 'Stanislaw Pomianowski, MD PhD Prof', 'role': 'CONTACT', 'email': 'spom@spskgruca.pl', 'phone': '+48227794031', 'phoneExt': '481'}], 'facility': 'Department of Orthopaedics and Traumatology, Postgraduate Center for Medical Education, Professor A. Gruca Teaching Hospital', 'geoPoint': {'lat': 52.10577, 'lon': 21.26129}}], 'centralContacts': [{'name': 'Rafal Kaminski, MD PhD', 'role': 'CONTACT', 'email': 'rkaminski@spskgruca.pl', 'phone': '48 227754031', 'phoneExt': '469'}], 'overallOfficials': [{'name': 'Rafal KAminski', 'role': 'STUDY_CHAIR', 'affiliation': 'CMKP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rafał Kamiński', 'investigatorAffiliation': 'Centre of Postgraduate Medical Education'}}}}