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

Completed

• Conditions: Infection

• Registration Number: NCT02779504
• Lead Sponsor: Stryker Orthopaedics

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-18
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infection rate in Agluna Treated METS in comparison to infection rate in untreated METs	Within 12 months following implantation of the METs implant	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal National Orthopaedic Hospital; 🇬🇧 Stanmore, United Kingdom