Clinical Trials

Overview

About this study

The purpose of this retrospective cohort study is to evaluate module junction failure of the Zimmer revision systems including NexGen and Persona revision systems. 

The objectives are to report on the failure rate of Zimmer revision systems including NexGen and Persona revision systems at the modular junction site on femoral and tibial components, and to evaluate the risk factors and commonalities of patients who underwent revision total knee arthroplasty with Zimmer revision systems including NexGen and Persona revision systems and sustained failure at the modular junction site.

We will initially query Mayo Total Joints Registry database to obtain a list of patients who revision total knee arthroplasty with Zimmer revision systems including NexGen and Persona revision systems.  We will then search within this list for patients with a history of re-revision (unless revision components used in primary) or implant failure at modular junction site of femoral or tibial component. Cases will be reviewed up through 12/31/2019 to allow for two-year follow-up. We will review imaging of patients who meet this criterion including pre-operative/post-operative revision total knee arthroplasty radiographs, and Zimmer revision systems’ failure/injury radiographs. We will review these cases to find etiology of failure, specifically studying if this failure took place at the modular junction sites, and if so, at what rate. We will then complete a more detailed chart review of the included patients to help establish trends and commonalities between patients in this population whose hardware underwent failure. Once the data has been collected using chart and database review, we will complete statistical analyses help establish failure rate. We will also complete subgroup analysis to compare outcomes and risk factors of patients in this selected group. We will also contact patients in study view email and phone to further evaluate risk factors and outcomes.

This study has no financial implications or budget associated with implementation or data analysis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

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