Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT01052233
Status:
UNKNOWN
Last Update Posted:
2015-01-21
First Post:
2010-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001182', 'term': 'Arthroscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2010-01-19', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological assessment of OA of the knee (Kellgren-Lawrence -classification)', 'timeFrame': '2 and 10 years postoperatively'}], 'secondaryOutcomes': [{'measure': 'ACR (The American College of Rheumatology) clinical criteria for Osteoarthritis of the knee', 'timeFrame': '2 and 10 years postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sham-surgery', 'Development of osteoarthritis', 'Randomized, double-blinded, placebo-controlled'], 'conditions': ['Osteoarthritis of the Knee', 'Arthroscopy', 'Meniscal Tear']}, 'referencesModule': {'references': [{'pmid': '39277028', 'type': 'DERIVED', 'citation': 'Sillanpaa N, Iivanainen M, Turkiewicz A, Sihvonen R, Paavola M, Taimela S, Jarvinen TLN, Englund M. Effect of arthroscopic partial meniscectomy on structural degeneration of the knee - A 5-year MRI-based follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Osteoarthritis Cartilage. 2025 Feb;33(2):276-282. doi: 10.1016/j.joca.2024.09.003. Epub 2024 Sep 12.'}, {'pmid': '32855201', 'type': 'DERIVED', 'citation': 'Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Kalske J, Nurmi H, Kumm J, Sillanpaa N, Kiekara T, Turkiewicz A, Toivonen P, Englund M, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators. Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Br J Sports Med. 2020 Nov;54(22):1332-1339. doi: 10.1136/bjsports-2020-102813. Epub 2020 Aug 27.'}, {'pmid': '31937344', 'type': 'DERIVED', 'citation': 'Sihvonen R, Kalske R, Englund M, Turkiewicz A, Toivonen P, Taimela S, Jarvinen TLN; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators. Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial. Trials. 2020 Jan 14;21(1):76. doi: 10.1186/s13063-019-3833-2.'}]}, 'descriptionModule': {'briefSummary': 'It has been previously demonstrated that the risk for the development of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se, the surgery, or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.', 'detailedDescription': 'It has been previously demonstrated that the risk for the development/progression of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se (i.e., adverse mechanical effect on knee cartilage), the surgery (resection of the meniscus, and subsequent loss of cushion within the knee), or whether the development of knee osteoarthritis is completely independent of the two.\n\nAccordingly, the aim of the study is to investigate the effect of Arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.\n\nPatients included in the study will be randomized into one of two groups: arthroscopic partial meniscectomy and diagnostic arthroscopy (sham-surgery). The presence of knee osteoarthritis will be assessed preoperatively and 2, 5, and 10 years after the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 35 to 65 years of age.\n2. A pain located on the medial joint line of the knee that has persistent at least for 3 months.\n3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.\n4. Tear of the medial meniscus on MRI.\n5. Degenerative rupture of the medial meniscus confirmed at arthroscopy.\n\nExclusion Criteria:\n\n1. Acute, trauma-induced onset of symptoms.\n2. Locking or painful snapping of the knee joint.\n3. A surgical operation performed on the affected knee.\n4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).\n5. Osteoarthritis on knee radiographs (Kellgren-Lawrence \\> 1).\n6. Acute (within the previous year) fractures of the knee.\n7. Decreased range of motion of the knee.\n8. Instability of the knee.\n9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.\n10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.'}, 'identificationModule': {'nctId': 'NCT01052233', 'briefTitle': 'Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'Effect of Arthroscopic Partial Resection of Degenerative Meniscus Tear on Development of Knee Osteoarthritis: Which is the Chicken and the Egg?', 'orgStudyIdInfo': {'id': '9037/403/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arthroscopic partial meniscectomy', 'description': 'Arthroscopic partial resection of degenerative tear of medial meniscus', 'interventionNames': ['Procedure: Arthroscopic partial meniscectomy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Arthroscopy (diagnostic)', 'description': 'Diagnostic arthroscopy of the knee', 'interventionNames': ['Procedure: Arthroscopy (diagnostic)']}], 'interventions': [{'name': 'Arthroscopic partial meniscectomy', 'type': 'PROCEDURE', 'description': 'Arthroscopic partial meniscectomy of the degenerative tear of medial meniscus', 'armGroupLabels': ['Arthroscopic partial meniscectomy']}, {'name': 'Arthroscopy (diagnostic)', 'type': 'PROCEDURE', 'description': 'Diagnostic arthroscopy of the knee', 'armGroupLabels': ['Arthroscopy (diagnostic)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Central Finland Hospital District', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '33101', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere City Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Raine Sihvonen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere City Hospital'}, {'name': 'Teppo Järvinen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, {'name': 'Central Finland Hospital District', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Teppo Jarvinen', 'investigatorAffiliation': 'Tampere University'}}}}