NCT04666519

Zonulin Biomarker for Diagnosis of Hip and Knee Infections

Status unknown Last updated 14 December 2020

What this trial tests

trial testing Zonulin Biomarker in Surgical Site Infection in 100 participants. Status unknown.

Timeline

15 November 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Rothman Institute Orthopaedics
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	100
Start date	15 November 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Zonulin Biomarker

Conditions studied

• Surgical Site Infection — all drugs for Surgical Site Infection →
• Zonulin — all drugs for Zonulin →

Sponsor

Rothman Institute Orthopaedics

Who can join

18 and older, any sex, with Surgical Site Infection or Zonulin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Gut permeability may be associated with periprosthetic joint infection after total hip and knee arthroplasty.
   Chisari E, Cho J, Wouthuyzen-Bakker M, Parvizi J. · · 2022 · cited 26× · PMID 36064964 · DOI 10.1038/s41598-022-19034-6