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Are Zonulin Levels Associated With a Higher Risk of Infection?
Sponsor study identifier
observational
100
1 country
1
Study Start
November 15, 2020
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 15, 2020
Actual (reported)December 8, 2020
Actual (reported)December 14, 2020
Actual (reported)December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Accuracy of Infection Diagnosis
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
90 days
During revision hip and knee surgery, discarded fluid/blood will be tested for the presence of zonulin biomarkers
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Patients who are undergoing a primary or aseptic revision total hip or knee replacement and patients who are having a revision hip or knee replacement for infection
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States
First Submitted
December 8, 2020
First Posted
December 14, 2020
Study Start
November 15, 2020
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 14, 2020
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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