Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-01-28 @ 10:40 PM
Study NCT ID:
NCT02651961
Status:
UNKNOWN
Last Update Posted:
2018-05-22
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000088562', 'term': 'Persistent Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2022-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2016-01-07', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-utility ratio (ICER)', 'timeFrame': '12 months post-operative'}], 'secondaryOutcomes': [{'measure': 'Quality of life : EQ-5D questionnaire', 'timeFrame': '12 months post-operative', 'description': 'Patient-reported generic (EQ-5D) outcomes questionnaire'}, {'measure': 'Pain : VAS score', 'timeFrame': '12 months post-operative', 'description': 'Patient-reported pain score with visual analogic scale'}, {'measure': 'Number of Persistence or recurrence of infection for all participants', 'timeFrame': '24 months post-operative'}, {'measure': 'Occurrence of complications', 'timeFrame': '24 months post-operative'}, {'measure': 'number of Necessity of reoperation for all patient', 'timeFrame': '12 months post-operative', 'description': 'necessity of reoperation will be assessed with clinical examination'}, {'measure': 'Operating time of all surgical procedures', 'timeFrame': 'procedure', 'description': 'operating time is from time of entrance in the operating room to time of the end of intervention (hh:mm)'}, {'measure': 'Duration of whole treatment', 'timeFrame': '12 months post-operative'}, {'measure': 'Cost of complication treatment', 'timeFrame': '12 months post-operative'}, {'measure': 'Cost of repeat surgery', 'timeFrame': '12 months post-operative'}, {'measure': 'Quality of life : Oxford hip or knee questionnaires', 'timeFrame': '12 months post-operative', 'description': 'Patient-reported specific (Oxford) outcomes questionnaire'}, {'measure': 'cost of whole treatment', 'timeFrame': '12 months post-operative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total hip prosthesis', 'Total knee prosthesis', 'Chronic infection', 'One stage exchange', 'Two stage exchange', 'Cost-effectiveness'], 'conditions': ['Chronically Infected Total Hip of Knee Prosthesis']}, 'descriptionModule': {'briefSummary': 'Chronic infection after total joint arthroplasty generally requires implant exchange. Two stage exchange is considered as the gold standard procedure. However, some authors suggest that one stage exchange may be as effective. No consensus exists in the current literature. The purpose of the study was to evaluate the cost of both strategies in comparison to their success rate.', 'detailedDescription': 'The primary criterion will be the cost-utility ratio (ICER) at 12 months follow-up.\n\nThe secondary criteria will be:\n\n* quality of life;\n* pain;\n* persistence or recurrence of infection;\n* occurrence of complications ;\n* necessity for reoperation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Chronically infected total hip or knee arthroplasty requiring implant exchange\n* Affiliation to a social security system\n* Signed informed consent\n* Effective contraception during all study\n\nExclusion Criteria:\n\n* Repeat exchange after failure of a prior treatment for infection\n* Multiple implant infection\n* Infection due to mycobacteria or fungus\n* Pregnancy / Breast feeding\n* Patient under judicial protection\n* Impossibility to give informed consent for any reason\n* Participation to another study'}, 'identificationModule': {'nctId': 'NCT02651961', 'acronym': 'IPRO', 'briefTitle': 'Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Cost-effectiveness Evaluation of One Stage Versus Two Stage Exchange for Chronically Infected Total Hip and Total Knee Prostheses', 'orgStudyIdInfo': {'id': '6262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One stage exchange', 'description': 'One stage exchange of the chronically infected implant', 'interventionNames': ['Procedure: Exchange of total hip or knee arthroplasty on same time']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two stage exchange', 'description': 'Two stage exchange of the chronically infected implant', 'interventionNames': ['Procedure: Exchange of total hip or knee arthroplasty in two time']}], 'interventions': [{'name': 'Exchange of total hip or knee arthroplasty on same time', 'type': 'PROCEDURE', 'description': 'Removal of the index implants, extensive debridement, reimplantation of a new prosthesis', 'armGroupLabels': ['One stage exchange']}, {'name': 'Exchange of total hip or knee arthroplasty in two time', 'type': 'PROCEDURE', 'description': 'Removal of the index implants in first time, extensive debridement, reimplantation of a new prosthesis in seconde time', 'armGroupLabels': ['Two stage exchange']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Yves JENNY, MD', 'role': 'CONTACT', 'email': 'jean-yves.jenny@chru-strasbourg.fr', 'phone': '0388552456'}], 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Hélène SOAVELO', 'role': 'CONTACT', 'email': 'helene.soavelo@chru-strasbourg.fr', 'phone': '+33388116559'}], 'overallOfficials': [{'name': 'Jean-Yves JENNY, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Strasbourg's University Hospitals"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}