Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-31 @ 2:39 AM
Study NCT ID:
NCT04598568
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2025-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Society Score', 'timeFrame': '2 years', 'description': 'The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery\n\nThe Knee Society Score consists of an objective score (0-100 points) and a score for function (0-100 points).\n\nA higher score means a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Radiographic evaluation of lucent lines', 'timeFrame': '6-12 weeks - 10 years', 'description': 'The second endpoint of interest is the incidence of lucent lines measured in millimeters by means of standard X-rays.'}, {'measure': 'Adverse Events and Complications', 'timeFrame': '6-12 weeks - 10 years', 'description': 'Documentation of complication(s):\n\n\\- Description of complication with the UKA\n\nDocumentation of component revision(s) (Adverse Events):\n\n* Reason(s) for revision(s)\n* Revised component(s)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Arthropathy']}, 'referencesModule': {'references': [{'pmid': '33810795', 'type': 'DERIVED', 'citation': 'Tille E, Beyer F, Auerbach K, Tinius M, Lutzner J. Better short-term function after unicompartmental compared to total knee arthroplasty. BMC Musculoskelet Disord. 2021 Apr 2;22(1):326. doi: 10.1186/s12891-021-04185-w.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.', 'detailedDescription': 'Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the balanSys UNI fix knee prosthesis.\n\nIn total at least 100 participants in 3 clinics are included in this multicenter study.\n\nThe primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery.\n\nThe following parameters will be collected during the regular clinical and radiological follow-up: Knee Society Score, Knee and Osteoarthritis Outcome Score (KOOS), radiographic evaluation and detection of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'according to Eligibility Criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent form (signed by participant and investigator)\n* Primary implantation\n* Age at inclusion: Between 18 and 90 years old\n* Willing to participate in the follow-up\n\nExclusion Criteria:\n\n* Missing Informed consent form\n* Known or suspected non-compliance (e.g. drug or alcohol abuse)\n* Enrollment of the investigator, his/her family, employees and other dependent persons\n* Patient younger than 18 years old\n* Revision surgery\n* Does have a known allergy to metal in medical devices\n* Suffers from ACL rupture\n* Pregnancy or in the breast feeding period'}, 'identificationModule': {'nctId': 'NCT04598568', 'briefTitle': 'Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mathys Ltd Bettlach'}, 'officialTitle': 'Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique', 'orgStudyIdInfo': {'id': '20140206_Protocol_V5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'balanSys UNI knee prosthesis', 'description': 'Participants treated with a balanSys® UNI knee prosthesis', 'interventionNames': ['Device: balanSys UNI']}], 'interventions': [{'name': 'balanSys UNI', 'type': 'DEVICE', 'description': 'Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique', 'armGroupLabels': ['balanSys UNI knee prosthesis']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mathys Ltd Bettlach', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}