Clinical trial NCT02779504: Post Market Clinical Follow Up Study for Evaluation of Agluna® METS
Official title: Post Market Clinical Follow Up for the Evaluation of Reducing the Risk of Infection Using the Agluna® Treated METS Modular System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Implanted with a METS™ modular implant at the Royal National Orthopaedic Hospital, Stanmore.
2. Patient was between 18 years old and 70 years old at the time of implantation.
3. Patient has been followed up for at least 12 months following implant surgery

Exclusion Criteria:

1. Patient is obese
2. Patient is currently or has been involved in pending litigation or worker's compensation
3. Patient has participated in another clinical investigation or study with an investigational medical device within the last 60 days

Primary outcomes:
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
Secondary outcomes:
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
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
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
Study officials:
affiliation: Royal National Orthopaedic Hospital
name: William JS Aston, MBBSMRCSFRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.