Detection of Periprosthetic Joint Infection in Synovial Fluid

Overview

About this study

The purpose of this study is to demonstrate the tests' performance when compared to the detection of periprosthetic joint infection (PJI) using the Musculoskeletal Infection Society (MSIS) criteria-based definition of PJI for diagnosing PJI. This criteria-based definition of PJI places emphasis on culture techniques that identify pathogens, but also provides for minor criteria that can be used to diagnose PJI. This study will also calculate the tests' clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV).

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:

Subject has a total knee and/or hip joint arthroplasty
The subject will be evaluated for revision surgery. Operative samples are required for full MSIS classification.
Subject is ≥22 years of age. -
Subject has had no recent injections or surgeries of the joint (within past 6 weeks). -
Subject has or will have all of the medical tests required to allow MSIS classification.
Subject signs informed consent form.

Exclusion Criteria:

Subject does not have a total knee and/or hip joint arthroplasty.
Healthy subjects without medical need for aspiration.
Subject did not have a revision surgery.
Subjects with a diagnostic synovial fluid specimen collection within the past 14 days.
Subjects <22 years of age.
Subject has had an injection, lavage, or surgery of the joint within the past 6 weeks.
Subject does not have all of the medical tests required for MSIS classification.
Subject does not sign informed consent form.

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
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Robin Patel, M.D.	Closed for enrollment
Rochester, Minn. Mayo Clinic principal investigator Robin Patel, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robin Patel, M.D.

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

Robin Patel, M.D.

Closed for enrollment

More information

Publications

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