NCT04390607

Brief Summary

The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

May 11, 2020

Last Update Submit

September 22, 2020

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

  • Receiver Operating Curve (ROC) analysis

    20 minutes

Study Arms (1)

Subjects undergoing revision joint surgery

Diagnostic Test: leukocyte esterase electrochemical assay

Interventions

leukocyte esterase electrochemical assayDIAGNOSTIC_TEST

A sample of blood drawn for routine standard of care laboratory assessments will be used to also test the new electrochemical assay. This is a validation study and the results of the electrochemical assay will not be used to treat patients

Subjects undergoing revision joint surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be a prospective study with consecutive revision joint surgery patients determined to be in one of three groups: 1) patients undergoing revision joint replacement for presumed aseptic loosening, 2) patients undergoing irrigation and debridement with implant retention, and 3) patients undergoing two stage revision for infection. We will also recruit a small number of patients undergoing primary joint replacement (Jefferson hospital only).

You may qualify if:

  • : consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection

You may not qualify if:

  • known active gout flare
  • existing corrosion or metallosis
  • inflammatory arthritis
  • preexisting diagnosis of infection in the same joint
  • patients undergoing second-stage procedure for infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10003, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 15, 2020

Study Start

November 1, 2020

Primary Completion

September 30, 2021

Study Completion

October 31, 2021

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations

US(1)