Zonulin Biomarker for Diagnosis of Hip and Knee Infections

Sponsor
Rothman Institute Orthopaedics (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04666519
Collaborator
(none)
100
1
13.5
7.4

Study Details

Study Description

Brief Summary

Prior studies investigating the etiopathogenesis of surgical site infection (SSI) traditionally suggested three main ways for the infection to occur: local contamination occurring during the surgery, hematogenous translocation of bacteria during concomitant bacteraemia, and contamination from adjacent infected tissues by the progression of the infective process. While most of the research on SSI focused on minimizing any source of pathogens at the time of the surgery, emerging evidence shows how acute and chronic SSI can emerge more often from bacteraemia or other tissues in the body, such as the gastrointestinal system, especially when dysbiosis and high permeability are retrieved.

Intercellular tight junctions (TJs) tightly regulate paracellular antigen trafficking. TJs are extremely dynamic structures that operate in several critical functions of the intestinal epithelium under both physiological and pathological circumstances. This paradigm was subverted in 1993 by the discovery of zonula occludens 1 (ZO-1) as the first component of the TJ complex 11 now being comprised of more than 150 proteins, including occludin, claudins, junctional adhesion molecules (JAMs), tricellulin , and angulins . However, despite major progress in our knowledge on the composition and function of the intercellular TJ, the mechanisms by which they are regulated are still incompletely understood. One of the breakthroughs in understanding the role of gut permeability in health and disease has been the discovery of zonulin, and the only physiologic intestinal permeability modulator described so far.

Since then, zonulin has been used as a marker for increased intestinal permeability and associated with soluble CD14 (sCD14) and lipopolysaccharide (LPS), other common markers associated with surgical complication, inflammation, and bacterial translocations.

As such, Zonulin could be a biomarker for mid- and long-term complications after total joint replacement such as infection, loosening, and mechanical complications associated with painful symptomatology.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Zonulin Biomarker

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Are Zonulin Levels Associated With a Higher Risk of Infection?
Actual Study Start Date :
Nov 15, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Accuracy of Infection Diagnosis [90 days]

    Zonulin levels will be tested on discarded blood/fluid during revision hip or knee replacement to see if there is a correlation between the zonulin levels and the development of an infection after their surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients who underwent primary or aseptic revision total hip and knee arthroplasty.

  • Patients who underwent revision total hip and knee arthroplasty for infective reasons

  • Patients 18 years of age or older

Exclusion Criteria:
  • Patients younger than 18 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rothman Orthopaedic Institute Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT04666519
Other Study ID Numbers:
  • JPAR06D.229
First Posted:
Dec 14, 2020
Last Update Posted:
Dec 14, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2020