Risk of Infection Using Agluna Treated METS System
Research type
Research Study
Full title
Clinical Study Protocol for the Evaluation of Reducing the Risk of Infection using the Agluna® Treated METS Modular System from Stanmore Implants
IRAS ID
165128
Contact name
Amit Agrawal
Contact email
Sponsor organisation
Stanmore Implants Worldwide Ltd
Duration of Study in the UK
0 years, 3 months, 12 days
Research summary
The Agluna® (antimicrobial ionic silver surface technology) is used to treat the surface of the Stanmore Implants Worldwide, 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 our clinical claims.
The study will be conducted at one site in the UK; the Royal National Orthopaedic Hospital, Stanmore. The sample size is expected to be approximately 100 patients. There will be an initial pilot of 20 subjects, used to evaluate the feasibility of the study conduct and to identify the need of any study design modification. All cases in the study must have been followed up for 12 months prior to the retrospective collection of the data.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0199
Date of REC Opinion
25 Apr 2016
REC opinion
Favourable Opinion