Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 10:36 AM
Study NCT ID:
NCT00409266
Status:
WITHDRAWN
Last Update Posted:
2021-11-10
First Post:
2006-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "Investigator medical practice didn't allow to move forward with the study.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2006-12-06', 'studyFirstSubmitQcDate': '2006-12-07', 'lastUpdatePostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '16950043', 'type': 'BACKGROUND', 'citation': 'Stoeckl B, Nogler M, Krismer M, Beimel C, de la Barrera JL, Kessler O. Reliability of the transepicondylar axis as an anatomical landmark in total knee arthroplasty. J Arthroplasty. 2006 Sep;21(6):878-82. doi: 10.1016/j.arth.2005.10.020.'}]}, 'descriptionModule': {'briefSummary': 'The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and Females over the age of 18 and equal to or less than the age of 60\n* Patients scheduled for elective Total knee arthroplasty surgery\n* Patients who have signed informed consent and HIPAA Authorization\n* Able to speak and understand English\n\nExclusion Criteria:\n\n* Patients presenting with evidence of recent trauma, active infection, chronic pain syndrome of the spine, dementia or have been diagnosed with Alzheimer's disease\n* Pregnant women\n* Patients that will not sign the informed consent"}, 'identificationModule': {'nctId': 'NCT00409266', 'briefTitle': 'CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Instruments'}, 'officialTitle': 'CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthropla', 'orgStudyIdInfo': {'id': 'NAV06-01US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Functional flexion axis of the knee', 'description': 'The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.', 'interventionNames': ['Device: Computer assisted navigation']}], 'interventions': [{'name': 'Computer assisted navigation', 'type': 'DEVICE', 'armGroupLabels': ['Functional flexion axis of the knee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02360', 'city': 'Plymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Jordan Hospital', 'geoPoint': {'lat': 41.95844, 'lon': -70.66726}}], 'overallOfficials': [{'name': 'R S Oliver, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Instruments', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}