Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 10:55 AM
Study NCT ID:
NCT02779504
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow Up Study for Evaluation of Agluna® METS
Sponsor:
Stryker Orthopaedics
Organization:
Study Overview
Official Title:
Post Market Clinical Follow Up for the Evaluation of Reducing the Risk of Infection Using the Agluna® Treated METS Modular System
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
This 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.
This 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.
Detailed Description:
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.
The 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.
The 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: