Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-29 @ 12:04 PM
Study NCT ID:
NCT02019433
Status:
TERMINATED
Last Update Posted:
2017-01-26
First Post:
2013-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant Survival Rates', 'timeFrame': '12 months', 'description': 'Implant survival is analysed at follow-up examinations at 3 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcome', 'timeFrame': '3 and 12 months', 'description': 'Harris Hip Score'}, {'measure': 'Pain', 'timeFrame': '3 and 12 months', 'description': 'Visual Analogue Scale (VAS)'}, {'measure': 'Osteolysis', 'timeFrame': '3 and 12 months', 'description': 'Radiographic Outcome'}, {'measure': 'Ossifications', 'timeFrame': '3 and 12 months', 'description': 'Radiographic Outcome'}, {'measure': 'Implant Position', 'timeFrame': '3 and 12 months', 'description': 'Radiographic Outcome'}, {'measure': 'Migration of Structan®', 'timeFrame': '3 and 12 months', 'description': 'Radiographic Outcome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['THA, augment, revision, pelvis'], 'conditions': ['Total Hip Arthroplasty Revision']}, 'descriptionModule': {'briefSummary': 'Implant Survival as well as clinical and radiological Follow-Up of acetabular Titan-Augment Structan®'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'specialist clinical centre', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age 18 years\n* Indication for cementless hip arthroplasty with acetabular defects that need Allograft or titanium augment\n* Patient consent for study participation\n* Physical and mental willingness to participate in the follow-ups\n\nExclusion Criteria:\n\n* Patient not available for follow-up\n* Increased anesthetics risks for the patient according to the "American Society of Anesthesiology": ASA IV\n* Tumor\n* Alcohol- or Drug abuse\n* Permanent cortisone therapy\n* Clinically relevant infection\n* (Planned) pregnancy'}, 'identificationModule': {'nctId': 'NCT02019433', 'briefTitle': 'Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Post Market Clinical Follow-Up of Acetabular Titan-Augment Structan®', 'orgStudyIdInfo': {'id': 'AAG-O-H-1212'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Structan®', 'interventionNames': ['Device: Structan®']}], 'interventions': [{'name': 'Structan®', 'type': 'DEVICE', 'armGroupLabels': ['Structan®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Campus Berlin Mitte', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '73035', 'city': 'Göppingen', 'country': 'Germany', 'facility': 'Klinik am Eichert', 'geoPoint': {'lat': 48.70354, 'lon': 9.65209}}, {'zip': '51379', 'city': 'Leverkusen', 'country': 'Germany', 'facility': 'St. Remigius Krankenhaus Opladen', 'geoPoint': {'lat': 51.0303, 'lon': 6.98432}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}