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

NCT03694925 | Completed Results

• 1 other identifier: 18-882
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Calprotectin POC

  lateral flow point of care test

  Day of surgery

Secondary Outcomes (1)

• Calprotectin ELISA

  Day of surgery

Study Arms (3)

Primary total knee arthroplasty

Primary TKA patients included in the study, to provide a baseline level for calprotectin.

Diagnostic Test: Calprotectin test

Aseptic revision total knee arthroplasty

Aseptic revision TKA patients included in the study. These are patients who are not considered infected according to Musculoskeletal Infection Society criteria for infection.

Diagnostic Test: Calprotectin test

Revision septic total knee arthroplasty

Septic revision TKA patients included in the study. These are patients who are considered infected according to Musculoskeletal Infection Society criteria for infection.

Diagnostic Test: Calprotectin test

Interventions

Calprotectin test DIAGNOSTIC_TEST

Calprotectin will be measured both by ELISA and point of care test.

Aseptic revision total knee arthroplasty; Primary total knee arthroplasty; Revision septic total knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three groups: Primary total knee arthroplasty Aseptic revision total knee arthroplasty Septic revision total knee arthroplasty

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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Alison Klika
• Organization: Cleveland Clinic Arthroplasty Research Group

klikaa@ccf.org

4123017914

Study Officials

• Carlos Higuera, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 3, 2018
• Study Start: October 29, 2018
• Primary Completion: January 7, 2020
• Study Completion: March 4, 2020
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)