Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 5:53 AM
Study NCT ID:
NCT02566694
Status:
UNKNOWN
Last Update Posted:
2017-04-12
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Specimens From Patients With Orthopaedic Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004343', 'term': 'Drug Implants'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Periprosthetic tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-11', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-10-01', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cause of failure', 'timeFrame': 'At time of failure which is likely to be an average of 5 years post operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Implants']}, 'descriptionModule': {'briefSummary': 'The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.', 'detailedDescription': "The following tests will then be arranged:\n\n* Tribological assessment. The investigators will measure the wear of the explants using: 1) 'out of roundness'; and 2) Coordinate measuring. Semi-quantitative assessment of damage to the explants will also be conducted\n* Histological assessment. Tissue sent in formalin may determine the biomarker of diagnosis of metal ion synovitis where applicable\n* Metal ion measurement in body fluids where applicable (in patients with metal implants)\n* Diamond Light Source (this was approved in the 1st amendment). The tests will involve subjecting formalin fixed tissue to the high energy electron beam of the Diamond Light Source\n* Destructive testing of the implant is allowed by the patient (after all non-destructive tests have been performed)\n* Protein analysis of fluid and tissue if provided\n* Titanium levels from blood samples if provided\n* Gene expression testing to assess and understand mechanism of inflammation where applicable"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '11 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be both male and female, aged between 11-70 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)\n\nExclusion Criteria:\n\n* Patients not consenting to the study'}, 'identificationModule': {'nctId': 'NCT02566694', 'briefTitle': 'Analysis of Specimens From Patients With Orthopaedic Implants', 'organization': {'class': 'OTHER', 'fullName': 'Royal National Orthopaedic Hospital NHS Trust'}, 'officialTitle': 'Analysis of Specimens From Patients With Orthopaedic Implants', 'orgStudyIdInfo': {'id': 'RNOH LIRC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Failed implants', 'description': 'All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)', 'interventionNames': ['Procedure: Implant']}, {'label': 'Controls with different failure modes', 'description': 'We will compare findings with different types of orthopaedic implants and categories of failure mode.', 'interventionNames': ['Procedure: Implant']}], 'interventions': [{'name': 'Implant', 'type': 'PROCEDURE', 'description': 'orthopaedic implant', 'armGroupLabels': ['Controls with different failure modes', 'Failed implants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA7 4LP', 'city': 'Stanmore', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alister Hart, MD,FRCSG', 'role': 'CONTACT', 'email': 'a.hart@ucl.ac.uk'}, {'name': 'John Skinner, FRCS(Orth)', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alister Hart, MD, FRCSG', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal National Orthopaedic Hospital', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}], 'centralContacts': [{'name': 'Iva Hauptmannova, BSc', 'role': 'CONTACT', 'email': 'Iva.Hauptmannova@rnoh.nhs.uk'}], 'overallOfficials': [{'name': 'Alister Hart, FRCSG(Orth)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RNOH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal National Orthopaedic Hospital NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'Coxa, Hospital for Joint Replacement', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Orthopaedics', 'investigatorFullName': 'Professor Alister Hart', 'investigatorAffiliation': 'Royal National Orthopaedic Hospital NHS Trust'}}}}