Post Market Clinical Follow Up Study for Evaluation of Agluna® METS

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.

Study Overview

• Status: Completed
• Conditions: Infection

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.

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United Kingdom
  • Stanmore, United Kingdom, HA7 4LP
    • Royal National Orthopaedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Agluna treated METS; Patient implanted with Agluna treated METS
Untreated METS; Patient implanted with untreated METS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rate in Agluna Treated METS in comparison to infection rate in untreated METs	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.	Within 12 months following implantation of the METs implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Economic Impacts of Agluna Treated METS versus Untreated METS will be examined by performing a cost analysis of the procedures	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.	12 months follow up post implantation
Superiority of the Agluna® Treated METS™ over the untreated METS for infection reduction will be established if the confidence interval lies below 0.	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.	12 months follow up post implantation

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: William JS Aston, MBBSMRCSFRCS, Royal National Orthopaedic Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 16-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan 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