Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-04 @ 12:12 AM
Study NCT ID:
NCT01963520
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2013-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prosthetic Hip Infections: Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084063', 'term': 'Reinfection'}], 'ancestors': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 347}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2013-10-11', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of reinfection (relapse and new infection)', 'timeFrame': '2 years', 'description': 'The aim of this study was to prospectively determine the incidence of reinfection in patients with prosthetic hip infection after two years of follow up.'}], 'secondaryOutcomes': [{'measure': 'Incidence and causes of mechanical revision', 'timeFrame': '2 years'}, {'measure': 'Incidence and causes of death: infection or treatment related death, unrelated death', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hip prosthesis infection', 'Reinfection', 'Excision-synovectomy', 'One stage/two stage revision', 'Antibiotherapy'], 'conditions': ['Hip Prosthesis Infection']}, 'referencesModule': {'references': [{'pmid': '8609130', 'type': 'RESULT', 'citation': 'Tsukayama DT, Estrada R, Gustilo RB. Infection after total hip arthroplasty. A study of the treatment of one hundred and six infections. J Bone Joint Surg Am. 1996 Apr;78(4):512-23. doi: 10.2106/00004623-199604000-00005.'}]}, 'descriptionModule': {'briefSummary': 'Data from large prospective cohort studies of prosthetic joint infections are lacking.\n\nAim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.\n\nHypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).', 'detailedDescription': 'Aim of the study: to analyze the incidence of reinfection in patients with prosthetic hip infection who underwent surgery and received antibiotic therapy Methods: prospective cohort study in a French referral center for osteoarticular infections from November 2002 to March 2010. Population\n\n* all patients who consented to participate in the study with prosthetic hip infections treated by:\n* debridement-synovectomy for acute infection or with one-stage or two-stage\n* exchange arthroplasty or resection arthroplasty for chronic infection\n* antibiotic therapy\n\nOutcome:\n\n* Follow-up: minimum of 2 years\n* Events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hip arthroplasty infection who underwent surgery and received antibiotic therapy in a specialized French orthopaedic center for bone and joint infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hip arthroplasty infection\n* Surgical treatment: either debridement-synovectomy and prosthesis retention for acute infection or one or two-stage exchange arthroplasty or resection arthroplasty for chronic infection\n* Antibiotic therapy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prolonged suppressive antibiotic therapy\n* No surgical treatment'}, 'identificationModule': {'nctId': 'NCT01963520', 'acronym': 'PHIPS', 'briefTitle': 'Prosthetic Hip Infections: Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Diaconesses Croix Saint-Simon'}, 'officialTitle': 'Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years', 'orgStudyIdInfo': {'id': 'GHDCSS-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Diaconesses Croix Saint-Simon Hospital Group', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Valerie ZELLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diaconesses Croix Saint-Simon Hospital Group, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Diaconesses Croix Saint-Simon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator coordinator', 'investigatorFullName': 'Dr Valerie ZELLER', 'investigatorAffiliation': 'Groupe Hospitalier Diaconesses Croix Saint-Simon'}}}}