Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00351793
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2006-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007720', 'term': 'Knee Prosthesis'}], 'ancestors': [{'id': 'D007595', 'term': 'Joint Prosthesis'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2006-07-12', 'studyFirstSubmitQcDate': '2006-07-12', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness and Safety', 'timeFrame': '5 years', 'description': 'Will evaluate effectiveness and safety during a 5 year period via analysis of the Knee Society Score, revision status, and radiographic evaluation'}], 'secondaryOutcomes': [{'measure': 'Knee Society Clinical Rating', 'timeFrame': 'Pre-op, 6 months, 1 year, 2 years, 5 years'}, {'measure': 'Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Pre-op, 6 months, 1 year, 2 years, 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the outcomes of the GENESIS II Posterior Stabilized Total Knee Replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Total knee replacement candidates', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A combined deformity of \\<30 degrees = group 1\n* A combined deformity of \\>30 degrees = group 2\n* Patient is willing to consent to participate in the study\n* Patient is available for follow-up through at least 2 years but preferably 5 years\n* Patient has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk\n* Patients who are fluent in English and are able to understand their role in a clinical trial\n\nExclusion Criteria:\n\n* Active, local infection or systemic infection\n* Fibromyalgia patients\n* Patients whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol and or are reasonably unlikely to be compliant with the prescribed routine and the follow-up evaluation schedule'}, 'identificationModule': {'nctId': 'NCT00351793', 'briefTitle': 'A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'A Clinical Trial Follow-up Study of the Genesis II Posterior Stabilized Total Knee Replacement', 'orgStudyIdInfo': {'id': 'CDHA-RL-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Combined Deformity <30 degrees', 'interventionNames': ['Device: Knee Implant']}, {'label': 'Combined Deformity >30 degrees', 'interventionNames': ['Device: Knee Implant']}], 'interventions': [{'name': 'Knee Implant', 'type': 'DEVICE', 'description': 'Total knee replacement with Genesis II posterior stabilized knee', 'armGroupLabels': ['Combined Deformity <30 degrees', 'Combined Deformity >30 degrees']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Ross K Leighton, MD, FRCS(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Health, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ross Leighton', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon', 'investigatorFullName': 'Ross Leighton', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}