Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-28 @ 9:15 PM
Study NCT ID:
NCT05094258
Status:
UNKNOWN
Last Update Posted:
2021-11-30
First Post:
2021-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'After collecting all data about patients and patients participating in the study, the independent person who will evaluate the data will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with medial knee arthrosis will be randomized to receive unicompartmental knee prosthesis using mobile inserts in 30 patients and fixed inserts in 30 patients. Patients will be evaluated after at least 1 year of follow-up'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Form Health Survey (SF-36)', 'timeFrame': '0-1 year', 'description': 'SF-36 Score (0-100) to assess patient satisfaction at postoperative 1st year'}, {'measure': 'Knee injury and osteoarthritis outcome score (KOOS)', 'timeFrame': '0-1 year', 'description': 'Knee injury and osteoarthritis outcome score (0-100)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unicompartmental Knee osteoarthritis', 'Unicompartmental Knee prosthesis', 'Mobile insert', 'Fixed İnsert'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Comparison of the early clinical and radiological results and patient satisfaction of the mobile and fixed insert unicondylar knee prostheses routinely used in the clinic.', 'detailedDescription': 'Unicondylar knee prosthesis operation will be performed on patients with unicompartmental knee arthrosis who apply to our clinic. Patients will be randomized to use mobile or fixed inserts. After 1 year of follow-up, SF-36, KOOS and HSS scores will be taken to examine the clinical satisfaction of the patients. In addition, radiological evaluation will be made for the presence of osteolysis at the tibial implant interface between both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with degenerative knee arthritis with only one compartment affected\n\nExclusion Criteria:\n\n* Inflammatory Arthritis\n* Tricompartmental arthritis\n* Patients with fixed varus deformity greater than -10 degrees\n* Patients with fixed valgus deformity greater than -5 degrees\n* Patients with knee range of motion less than 90 degrees\n* Patients with more than 10 degrees of flexion contracture"'}, 'identificationModule': {'nctId': 'NCT05094258', 'briefTitle': 'Comparison of Early Results of Mobile and Fixed Insert Unicondylar Knee Prosthesis.', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Comparison of Early Clinical and Radiological Results and Patient Satisfaction of Mobile and Fixed Insert Unicondylar Knee Prosthesis', 'orgStudyIdInfo': {'id': '61813471876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mobile insert', 'description': 'Unicondylar knee arthroplasty with mobile insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.', 'interventionNames': ['Procedure: unicondylar knee prosthesis with mobile insert']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fixed insert', 'description': 'Unicondylar knee arthroplasty with fixed insert was applied to 30 patients determined by randomization. The patients were followed for 1 year.', 'interventionNames': ['Procedure: unicondylar knee prosthesis with fixed insert']}], 'interventions': [{'name': 'unicondylar knee prosthesis with mobile insert', 'type': 'PROCEDURE', 'description': 'Patients with unicondylar knee replacement using the mobile insert option', 'armGroupLabels': ['mobile insert']}, {'name': 'unicondylar knee prosthesis with fixed insert', 'type': 'PROCEDURE', 'description': 'Patients with unicondylar knee replacement using the fixed insert option', 'armGroupLabels': ['fixed insert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3344', 'city': 'Istanbul', 'state': 'Fatih', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'volkan Ezici', 'role': 'CONTACT', 'email': 'volkanezicimd@gmail.com', 'phone': '00905331508025'}], 'facility': 'Volkan Ezici', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Volkan Ezici', 'role': 'CONTACT', 'email': 'volkanezicimd@gmail.com', 'phone': '00905331508025'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participant data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'orthopaedic surgeon', 'investigatorFullName': 'Murat Sarikas', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}