Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-26 @ 6:13 PM
Study NCT ID:
NCT01601756
Status:
UNKNOWN
Last Update Posted:
2012-05-18
First Post:
2012-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-16', 'studyFirstSubmitDate': '2012-05-14', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restoration of Joint Line', 'timeFrame': 'postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks)', 'description': 'Difference between preoperatively planned and postoperatively achieved joint line'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['revision knee arthroplasty', 'navigation', 'joint line'], 'conditions': ['Revision Total Knee Arthroplasty Because of', 'Loosening', 'Instability', 'Impingement', 'or Other Reasons Accepted as Indications for TKA Exchange.', 'The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for revision knee arthroplasty'}, 'identificationModule': {'nctId': 'NCT01601756', 'acronym': 'NavRevKnie', 'briefTitle': 'Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision', 'orgStudyIdInfo': {'id': 'AAG-I-H-0917'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'navigated revision total knee arthroplasty', 'description': 'revision total knee arthroplasty with the aid of a navigation system', 'interventionNames': ['Device: navigated revision knee arthroplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional revision knee arthroplasty', 'description': 'revision knee arthroplasty using conventional instruments', 'interventionNames': ['Device: conventional revision knee arthroplasty']}], 'interventions': [{'name': 'navigated revision knee arthroplasty', 'type': 'DEVICE', 'description': 'revision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen).', 'armGroupLabels': ['navigated revision total knee arthroplasty']}, {'name': 'conventional revision knee arthroplasty', 'type': 'DEVICE', 'description': 'revision knee arthroplasty using conventional instruments', 'armGroupLabels': ['conventional revision knee arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg Matziolis, MD', 'role': 'CONTACT', 'email': 'georg.matziolis@charite.de', 'phone': '+49 30 450 615093'}, {'name': 'Georg Matziolis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orthopaedic Department, Charité - University Medicine Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Georg Matziolis, MD', 'role': 'CONTACT', 'email': 'georg.matziolis@charite.de', 'phone': '+49 30 450 615093'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aesculap AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Georg Matziolis', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}