Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT05128851
Status:
UNKNOWN
Last Update Posted:
2021-11-22
First Post:
2020-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Tibial Osteotomy With/Without Arthroscopy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-09', 'studyFirstSubmitDate': '2020-07-03', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'KOOS', 'timeFrame': '12 months', 'description': 'Knee Injury and Osteoarthritis Outcome Score'}, {'measure': 'KOOS', 'timeFrame': '24 months', 'description': 'Knee Injury and Osteoarthritis Outcome Score'}, {'measure': 'IKDC', 'timeFrame': '12 months', 'description': 'International Knee Documentation Committee - Subjective Knee Evaluation Form'}, {'measure': 'IKDC', 'timeFrame': '24 months', 'description': 'International Knee Documentation Committee - Subjective Knee Evaluation Form'}, {'measure': 'VAS', 'timeFrame': '12 months', 'description': 'Visual Analog Scale'}, {'measure': 'VAS', 'timeFrame': '24 months', 'description': 'Visual Analog Scale'}, {'measure': 'Blood test', 'timeFrame': '2 day', 'description': 'no inflammatory reaction - CRP, Il-6, CTx'}, {'measure': 'Blood test', 'timeFrame': '6 weeks', 'description': 'no inflammatory reaction - CRP, Il-6, CTx'}, {'measure': 'Blood test', 'timeFrame': '12 weeks,', 'description': 'no inflammatory reaction - CRP, Il-6, CTx'}], 'secondaryOutcomes': [{'measure': 'Kinematic MRI with [chondrogram]', 'timeFrame': '2 day,', 'description': 'Meniscus healing, cartilage quality'}, {'measure': 'Kinematic MRI with [chondrogram]', 'timeFrame': '24 months', 'description': 'Meniscus healing, cartilage quality'}, {'measure': 'X-ray - Baldini projection', 'timeFrame': '2 day', 'description': 'Patellofemoral joint measurements'}, {'measure': 'X-ray - Baldini projection', 'timeFrame': '24 months', 'description': 'Patellofemoral joint measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HTO', 'Degenerative Meniscus', 'Osteoarthritis', 'Microfracture'], 'conditions': ['Osteoarthritis, Knee', 'Meniscus; Degeneration']}, 'descriptionModule': {'briefSummary': 'This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.', 'detailedDescription': 'Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination\n* Intraarticular lesions in MRI\n* Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests\n\nExclusion Criteria:\n\n* no informed consent to participate in the study\n* age under 18 years or above 65\n* multilligament injury or single plane knee instability\n* another musculoskeletal disorders in lower limb\n* lower limb deformity requiring axis correction below 4o or above 12.5o • joints inflammatory diseases\n* ASA score \\> II'}, 'identificationModule': {'nctId': 'NCT05128851', 'briefTitle': 'High Tibial Osteotomy With/Without Arthroscopy.', 'organization': {'class': 'OTHER', 'fullName': 'Centre of Postgraduate Medical Education'}, 'officialTitle': 'Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.', 'orgStudyIdInfo': {'id': 'HTO_artro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Tibial Osteotomy and arthroscopy', 'description': 'High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions.', 'interventionNames': ['Procedure: HTO', 'Procedure: Arthroscopy treatment']}, {'type': 'SHAM_COMPARATOR', 'label': 'High Tibial Osteotomy', 'description': 'Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions.', 'interventionNames': ['Procedure: HTO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Tibial Osteotomy, arthroscopy and microfractures', 'description': 'High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture.', 'interventionNames': ['Procedure: HTO', 'Procedure: Arthroscopy treatment', 'Procedure: Micro fractures']}], 'interventions': [{'name': 'HTO', 'type': 'PROCEDURE', 'description': 'Hight Tibial Osteotomy', 'armGroupLabels': ['High Tibial Osteotomy', 'High Tibial Osteotomy and arthroscopy', 'High Tibial Osteotomy, arthroscopy and microfractures']}, {'name': 'Arthroscopy treatment', 'type': 'PROCEDURE', 'description': 'Arthroscopy treatment', 'armGroupLabels': ['High Tibial Osteotomy and arthroscopy', 'High Tibial Osteotomy, arthroscopy and microfractures']}, {'name': 'Micro fractures', 'type': 'PROCEDURE', 'description': 'Micro fractures', 'armGroupLabels': ['High Tibial Osteotomy, arthroscopy and microfractures']}]}, '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, Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital', 'geoPoint': {'lat': 52.10577, 'lon': 21.26129}}], 'centralContacts': [{'name': 'Rafał Kamiński', 'role': 'CONTACT', 'email': 'rkaminski@spskgruca.pl', 'phone': '+48227794031', 'phoneExt': '469'}], 'overallOfficials': [{'name': 'Rafał Kamiński', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PCME, Otwock, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Division', 'investigatorFullName': 'Rafał Kamiński', 'investigatorAffiliation': 'Centre of Postgraduate Medical Education'}}}}