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Zonulin Biomarker for Diagnosis of Hip and Knee Infections

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ClinicalTrials.gov Identifier: NCT04666519
Recruitment Status : Enrolling by invitation
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date December 8, 2020
First Posted Date December 14, 2020
Last Update Posted Date December 14, 2020
Actual Study Start Date November 15, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2020)
Accuracy of Infection Diagnosis [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Zonulin Biomarker for Diagnosis of Hip and Knee Infections
Official Title Are Zonulin Levels Associated With a Higher Risk of Infection?
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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
Condition
  • Surgical Site Infection
  • Zonulin
Intervention Diagnostic Test: Zonulin Biomarker
During revision hip and knee surgery, discarded fluid/blood will be tested for the presence of zonulin biomarkers
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 8, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04666519
Other Study ID Numbers JPAR06D.229
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor Rothman Institute Orthopaedics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date December 2020