Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02188095
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2014-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis
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': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2014-06-26', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival Rate of the Implant', 'timeFrame': '10 years', 'description': 'Kaplan-Meier Survival Rate up to 10 years'}], 'secondaryOutcomes': [{'measure': 'Hip disability and Osteoarthritis Outcome Score (HOOS)', 'timeFrame': 'preoperatively, intraoperatively + discharge, after 3 and 12 months 3, 5 and 10 years', 'description': 'Documentation of clinical outcome with HOOS Score'}, {'measure': 'Change of functional outcome over follow-up period (Harris Hip Score (HHS))', 'timeFrame': 'at discharge, after 3 and 12 months 3, 5 and 10 years', 'description': 'The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities.'}, {'measure': 'Pain Assessment', 'timeFrame': 'at 6 examinations during follow-up (discharge, after 3 and 12 months and 3, 5, and 10 years)', 'description': 'Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients are asked to mark their current pain level on the line.'}, {'measure': 'Shaftposition ap and lateral', 'timeFrame': '10 years', 'description': 'Radiological documentation of shaftposition in ap and lateral view discharge, after 3 and 12 months and 3, 5, and 10 years'}, {'measure': 'Stress Shielding', 'timeFrame': '10 years', 'description': 'Radiological documentation of stress shielding after 3 and 12 months and 3, 5, and 10 years'}, {'measure': 'Hypertrophies', 'timeFrame': '10 years', 'description': 'Radiological documentation of hypertrophies after 3 and 12 months and 3, 5, and 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Arthritis']}, 'descriptionModule': {'briefSummary': 'Clinical and radiological 10 year results of Excia T® Hip Stem'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient gave written informed consent\n* age ≥ 18 years\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02188095', 'briefTitle': 'Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Post Market Clinical Follow-Up Study of Excia T® Hip Prosthesis', 'orgStudyIdInfo': {'id': 'AAG-O-H-1401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Excia T®'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74906', 'city': 'Bad Rappenau', 'country': 'Germany', 'facility': 'Vulpius Klinik', 'geoPoint': {'lat': 49.23848, 'lon': 9.1018}}, {'zip': '70176', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Diakonie Klinikum Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Peter Aldinger, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diakonie-Klinikum Stuttgart'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}