Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty

Completed

Conditions studied: Prosthetic Joint Infection

In brief

The purpose of this study is to investigate whether there are quantifiable differences in the level of calprotectin in the synovial fluid that allow separation of different modes of joint implant failure (e.g. infected, aseptic loosening). A subset of primary TKA patients (with history of OA) will be included as a baseline.

Key facts

Study ID

NCT03694925

Run by

The Cleveland Clinic

People needed

156

Starts

2018-10-29

Expected to finish

2020-03-04

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥18 years of age
• Patient with a diagnosis of OA (for primary TKA only)
• 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

You may not qualify if…

• Subjects with a diagnostic synovial fluid specimen collection within the past 7 days
• Results are not available for medical tests required to perform MSIS classification
• Sample was obtained via lavage
• Quantity not sufficient (at least 1 ml required)

Where it is running

• Cleveland Clinic Florida — Weston, Florida, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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