Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT02424903
Status:
UNKNOWN
Last Update Posted:
2015-04-23
First Post:
2015-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Prosthetic Joint Infection Cohort Study- Hip, Knee and Shoulder Prosthetic Joint Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016459', 'term': 'Prosthesis-Related Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-20', 'studyFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection outcome', 'timeFrame': '12 months after surgery', 'description': 'The infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening).'}], 'secondaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': '12 months after surgery', 'description': 'by HARRIS HIP SCORE, CONSTANT SHOULDER SCORE, KNEE SOCIETY SCORE, OXFORD HIP SCORE, OXFORD KNEE SCORE, QUICK DASH SCORE'}, {'measure': 'lifequality evaluation', 'timeFrame': '12 months after surgery', 'description': 'by EQ5D5l-score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infection', 'prosthesis', 'hip', 'knee', 'shoulder'], 'conditions': ['Prosthesis-related Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare different approaches for the treatment of prosthetic joint revisions and to optimize the outcomes in patients with prosthetic joint infections (PJI) by improving the treatment concept of PJI.', 'detailedDescription': 'The aim of the study is to assess the impact of different surgical and antibiotic therapies on patients admitted for a septic or aseptic revision of the hip, knee or shoulder prosthesis. The decision whether the implant will be retained or removed or antimicrobial treatment is based on criteria of each participating center specialists.The success of different treatment algorithms will be measured in terms of infection free interval, functional outcome and quality of life. All consecutive patients who need a revision surgery to the hip, knee or shoulder will be included. Furthermore the study will investigate different diagnostic tests (microbiological and histological) for the diagnosis and the discrimination of septic and aseptic causes in prosthesis failures. Pathogens (microorganisms isolated from puncture of the joint, tissue samples sonication fluid and blood) will be collected to establish a biobank.The samples are obtained preoperatively and intraoperatively as part of routine care practice. The study is not randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted to hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* subject is older than 18 years of Age\n* written informed consent has been obtained\n* subject Needs a Revision surgery of the hip, knee or shoulder prosthesis\n\nExclusion Criteria:\n\n* subject is currently enrolled in another investigational study\n* inability to read and understand the participant's Information\n* subject is younger than 18 years of age"}, 'identificationModule': {'nctId': 'NCT02424903', 'acronym': 'EPJIC', 'briefTitle': 'European Prosthetic Joint Infection Cohort Study- Hip, Knee and Shoulder Prosthetic Joint Infection', 'organization': {'class': 'OTHER', 'fullName': 'Pro-Implant Foundation'}, 'officialTitle': 'European Prosthetic Joint Infection Cohort Study (EPJIC): Evaluation of the Treatment Approach for Hip, Knee and Shoulder Prosthetic Joint Revision Surgery', 'orgStudyIdInfo': {'id': 'PJI04/2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with prosthetic joint infection', 'description': 'Patients admitted for a septic revision surgery'}, {'label': 'without prosthetic joint infection', 'description': 'Patients admitted for an aseptic revision surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'contacts': [{'name': 'Maren Engel', 'role': 'CONTACT', 'email': 'maren.engel@charite.de', 'phone': '+4930450652417'}, {'name': 'Alessandra Catalina Bardelli', 'role': 'CONTACT', 'email': 'alessandra-catalina.bardelli@charite.de', 'phone': '+4930450552407'}, {'name': 'Andrej Trampuz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité, Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Maren Engel', 'role': 'CONTACT', 'email': 'maren.engel@charite.de', 'phone': '+4930450652417'}, {'name': 'Alessandra Catalina Bardelli', 'role': 'CONTACT', 'email': 'alessandra-catalina.bardelli@charite.de', 'phone': '+4930450552407'}], 'overallOfficials': [{'name': 'Andrej Trampuz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pro-Implant Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}