N/A
N=156
Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty
Prosthetic Joint Infection
Bottom Line
View on ClinicalTrials.gov: NCT03694925 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Calprotectin POC — 1; 3; 52; 29 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Calprotectin test (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calprotectin POC |
1; 3; 52; 29; 67; 1 | — |
| SECONDARY Calprotectin ELISA |
1; 3; 52; 29; 67; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03694925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.