Review of Modular Junction Site Failures of the Zimmer Revision Knee Systems

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.

Inclusion Criteria:

  • Male and female adults (age 18 and above).
  • Patients on the Mayo Clinic Total Joints Registry who underwent revision total knee arthroplasty with Zimmer revision systems including NexGen and persona systems prior to 12/31/19 to allow for 2 year follow-upand had modular junction failures. 

Exclusion Criteria: 

  • Individuals < 18 years of age.
  • Patients who have not undergone revision total knee arthroplasty with Zimmer NexGen revision systems.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Abdel, M.D.

Contact us for the latest status

Contact information:

Lauren Cole

(507) 266-1227

Cole.Lauren@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20544525

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