Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT02934802
Status:
UNKNOWN
Last Update Posted:
2019-04-17
First Post:
2016-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2016-10-14', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate at 5 years of the e motion PS Pro', 'timeFrame': 'the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty', 'description': 'The endpoint is the revision of at least one of the prosthesis components. If a patient withdraws from the study for any reason, counts as the end date for the survival of the implant of the last day on which the implants were well known even in place.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for which a Total Knee Prosthesis with e.motion® PS Pro was decided by the surgeon', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient having signed informed consent\n* Patients over 18 for which a Total Knee Prosthesis with e.motion® PS Pro was decided\n* Patients willing to participate in a 5 years follow-up\n\nExclusion Criteria:\n\n* Active or suspected infection\n* Tumor on the concerned knee\n* Patient vulnerable and under legal protection'}, 'identificationModule': {'nctId': 'NCT02934802', 'briefTitle': 'Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'BBraun Medical SAS'}, 'officialTitle': 'Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty', 'orgStudyIdInfo': {'id': 'AAG-O-H-1420'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Total Knee prothesis e motion PS Pro', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François BOILLOT', 'role': 'CONTACT', 'email': 'fboillot@hpsj.fr'}], 'facility': 'Groupe hospitalier Paris-St Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'François Boillot', 'role': 'CONTACT', 'email': 'fboillot@hpsj.fr', 'phone': '144123357', 'phoneExt': '+33'}, {'name': 'Boubker Zniber', 'role': 'CONTACT', 'email': 'bzniber@hpsj.fr', 'phone': '144123357'}], 'overallOfficials': [{'name': 'François Boillot', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe hospitalier Paris-St Joseph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BBraun Medical SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}