Infection Clinical Trial
Official title:
Post Market Clinical Follow Up for the Evaluation of Reducing the Risk of Infection Using the Agluna® Treated METS Modular System
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 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.
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