Detection of Periprosthetic Joint Infection in Synovial Fluid
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 15-009003
- Rochester, Minnesota: 15-009003
NCT ID: NCT02868736
Sponsor Protocol Number: CDD-CLI-001
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 |
|
More information
Publications
Publications are currently not available