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

NCT02779504 | Completed

• 1 other identifier: 16-01
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Agluna treated METS

Patient implanted with Agluna treated METS

Untreated METS

Patient implanted with untreated METS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (1)

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25628291 BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

• William JS Aston, MBBSMRCSFRCS

  Royal National Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 20, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)