Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-03 @ 2:24 AM
Study NCT ID:
NCT02779504
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2016-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow Up Study for Evaluation of Agluna® METS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection rate in Agluna Treated METS in comparison to infection rate in untreated METs', 'timeFrame': 'Within 12 months following implantation of the METs implant', 'description': 'The estimation of peri-prosthetic infection rate over twelve months following implantation with the Agluna® Treated METS™ Modular Tumour System. This will be compared to the infection rate of non- Agluna® Treated endoprostheses in a similar population.'}], 'secondaryOutcomes': [{'measure': 'Health Economic Impacts of Agluna Treated METS versus Untreated METS will be examined by performing a cost analysis of the procedures', 'timeFrame': '12 months follow up post implantation', 'description': 'To examine the health economic impacts of using the Agluna® Treated METS™ Modular Tumour System in comparison to the untreated METS™ Modular Tumour System, health economic questions will be addressed by analysing the costs of both treatments arms based on different models with varying assumptions for costs.'}, {'measure': 'Superiority of the Agluna® Treated METS™ over the untreated METS for infection reduction will be established if the confidence interval lies below 0.', 'timeFrame': '12 months follow up post implantation', 'description': 'To establish clinically relevant superiority of the Agluna® Treated METS™ Modular Tumour System in comparison to untreated METS™ Modular Tumour System, Investigation of superiority will be done analogously to the primary analysis. If the confidence interval lies completely below 0 superiority can be concluded. Additionally, to evaluate a clinical relevance the difference in infection rates will be analysed and interpreted numerically.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '25628291', 'type': 'BACKGROUND', 'citation': 'Wafa H, Grimer RJ, Reddy K, Jeys L, Abudu A, Carter SR, Tillman RM. Retrospective evaluation of the incidence of early periprosthetic infection with silver-treated endoprostheses in high-risk patients: case-control study. Bone Joint J. 2015 Feb;97-B(2):252-7. doi: 10.1302/0301-620X.97B2.34554.'}]}, 'descriptionModule': {'briefSummary': "The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of the METS (Modular Endoprosthetic Tumour System) medical devices, in order to reduce the risk of post surgical infections after orthopaedic endoprosthetic replacement surgery.\n\nThis Post Market Clinical Follow up study is designed to retrospectively establish the infection rate of a cohort patients who have received an Agluna® Treated METS implant and compare the clinical data to patients that have received an untreated METS implant; in order to provide evidence to support the investigators' clinical claims.", 'detailedDescription': 'This post-market clinical follow-up study will be a retrospective data comparison study of a series of Agluna® treated and untreated METS™ modular prostheses conducted at the Royal National Orthopaedic Hospital, Stanmore. The expected sample size will be 106, with 53 patients in each treatment arm (Agluna® treated vs untreated). However there will be an initial pilot of 20 subjects to evaluate the feasibility of the study conduct and to identify if any further study design modification are required.\n\nThe primary outcome is the estimation of the infection rate over 12 months following an Agluna (silver) treated METS™ endoprosthetic surgery. This will be compared to the infection rate of non-Agluna Treated devices in a similar population. Incidence of infection will be measured according to the accepted definition of periprosthetic joint infection from the American Academy of Orthopedic Surgeons. The study follow up period is 12 months after implantation. Secondary objectives are to examine the health economic impacts of using the Agluna® Treated METS™ Modular Tumour System in comparison to the untreated METS™ Modular Tumour System and to establish clinically relevant superiority of the Agluna® Treated METS™ Modular Tumour System in comparison to untreated METS™ Modular Tumour System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female subjects aged between 18 years and 70 years who have been implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore and the patient has been followed up for at least 12 months following implantation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore.\n2. Patient was between 18 years old and 70 years old at the time of implantation.\n3. Patient has been followed up for at least 12 months following implant surgery\n\nExclusion Criteria:\n\n1. Patient is obese\n2. Patient is currently or has been involved in pending litigation or worker's compensation\n3. Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days"}, 'identificationModule': {'nctId': 'NCT02779504', 'briefTitle': 'Post Market Clinical Follow Up Study for Evaluation of Agluna® METS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'Post Market Clinical Follow Up for the Evaluation of Reducing the Risk of Infection Using the Agluna® Treated METS Modular System', 'orgStudyIdInfo': {'id': '16-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Agluna treated METS', 'description': 'Patient implanted with Agluna treated METS'}, {'label': 'Untreated METS', 'description': 'Patient implanted with untreated METS'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA7 4LP', 'city': 'Stanmore', 'country': 'United Kingdom', 'facility': 'Royal National Orthopaedic Hospital', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}], 'overallOfficials': [{'name': 'William JS Aston, MBBSMRCSFRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal National Orthopaedic Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual patient data will not be made available as all patient data is anonymised and therefore can not be traced back to individual patients'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}