Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-20 @ 10:10 PM
Study NCT ID:
NCT04620395
Status:
UNKNOWN
Last Update Posted:
2020-11-09
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved diagnostic accuracy', 'timeFrame': 'up to 3 months', 'description': 'Comparison of the specificity and sensibility of microbiological results for punch biopsies, the synovial fluid tap, pre-interventional blood Analysis, arthroscopic biopsies for confirmation/exclusion of a bacterial or fungal periprosthetic infection'}], 'secondaryOutcomes': [{'measure': 'Rate of chronic periprosthetic low-grade-infections', 'timeFrame': 'up to 3 Months', 'description': 'The incidence of hidden chronic periprosthetic infections'}, {'measure': 'Correlation of microbiological results from percutaneous Punch biopsy with intraoperative findings at Revision', 'timeFrame': 'up to 6 Months', 'description': 'Correlation of pre-revision microbiological findings and the samples taken during the endoprosthesis replacement operation, in particular the sonicate of the prosthesis and the periprosthetic membrane (gold standard for infection diagnostics)'}, {'measure': 'Total Cost of Infection Diagnostics for various used methods', 'timeFrame': '1 Month', 'description': 'Comparison of the respective Overall Costs for diagnostics of acute and chronic periprosthetic infections using a joint-tap, the novel punch biopsy method and arthroscopic biopsy'}, {'measure': 'Rate of prosthetic failure due to wear particles', 'timeFrame': 'up to 1 month', 'description': 'Incidence of presence of wear particles in pathomorphological examinations of the punch biopsies and the samples taken during the replacement operation'}, {'measure': 'Correlation of Synovialitis score and microbiological findings', 'timeFrame': 'up to 2 months', 'description': 'Correlation of Synovialitis score in pathomorphological examinations and microbiological verification of an acute or chronic periprosthetic infection'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['prosthetic joint', 'infection', 'wear particles', 'prosthetic failure', 'antibiotics', 'biopsy', 'joint tap'], 'conditions': ['Wear of Articular Bearing Surface of Internal Prosthetic Joint', 'Infection Prosthetic', 'Infections Joint Prosthetic', 'Prosthetic Joint Infection', 'Prosthetic Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation.', 'detailedDescription': 'The main aim of the study is to demonstrate the superiority of a punch biopsy over a joint tap to rule out or prove septic prosthesis failure and thus establish a new diagnostic method. The subsequently calculated sensitivities of the previous and the procedure are used as the main indicator. In addition, we would like to prove that the total cost of diagnosing a septic / aseptic prosthesis failure using the proposed method has socio-economic advantages over the previous algorithm.\n\nOne of the secondary objectives is the evaluation of the use of a punch biopsy for simultaneous a priori pathomorphological examination of periprosthetic soft tissue samples for the determination of wear particles. Furthermore, the study is intended to demonstrate a shortening of the time span between the first suspected diagnosis of septic prosthesis failure and its reliable exclusion / detection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preceding implantation of a shoulder, hip or knee endoprosthesis\n* Acute or chronic pain in the joint\n* Periprosthetic fracture\n* Instability of the endoprosthesis\n* Indications of wear / insufficiency of the enclosed plastic spacers\n* Indications of metal abrasion\n* Primary misalignment of the implant\n\nExclusion Criteria:\n\n* Confirmed periprosthetic infection\n* Proven allergy to fast-acting local anesthetics'}, 'identificationModule': {'nctId': 'NCT04620395', 'acronym': 'SHARP', 'briefTitle': 'Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure', 'organization': {'class': 'OTHER', 'fullName': 'Vivantes Netzwerk für Gesundheit GmbH'}, 'officialTitle': 'Clinical Investigation of Septic and Aseptic Prosthetic Joint Failure - Percutaneous Punch Biopsy as a Novel Way of Diagnosis Confirmation', 'orgStudyIdInfo': {'id': 'STUD.20-062'}, 'secondaryIdInfos': [{'id': 'DRKS00022931', 'type': 'REGISTRY', 'domain': 'DRKS'}, {'id': 'U1111-1257-2609', 'type': 'REGISTRY', 'domain': 'Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Joint tap', 'description': 'Joint tap and aspiration of synovial fluid'}, {'type': 'EXPERIMENTAL', 'label': 'Punch biopsy', 'description': 'Punch biopsy of a prosthetic joint and extraction of 5-7 biopsies from the synovial membrane', 'interventionNames': ['Diagnostic Test: Punch biopsy']}], 'interventions': [{'name': 'Punch biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'A standardized biopsy kit is used for a synovial fluid tap and subsequent acquisition of up to 7 Punch biopsies through an introducer (part of the kit)', 'armGroupLabels': ['Punch biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13509', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karsten Labs, PD Dr. med.', 'role': 'CONTACT', 'email': 'karsten.labs@vivantes.de', 'phone': '+4930130121655'}, {'name': 'Rafal J Borucki, MD', 'role': 'CONTACT', 'email': 'rafal.borucki@vivantes.de', 'phone': '+4915129211687'}, {'name': 'Rafal J Borucki, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vivantes Humboldt-Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Rafal J Borucki, MD', 'role': 'CONTACT', 'email': 'rafal.borucki@vivantes.de', 'phone': '+4915129211687'}], 'overallOfficials': [{'name': 'Karsten Labs, PD Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Vivantes Humboldt Krankenhaus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vivantes Netzwerk für Gesundheit GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}