NCT05159739

Brief Summary

The investigators primary objective is to identify genetic factors that may increase the risk of patients developing a periprosthetic joint infections (PJI) following total joint arthroplasty (TJA). The investigators hope that by identifying genetic predispositions we will be able to provide patient specific care pathways to prevent or minimize the risk for PJI.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
23mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress82%
Mar 2018Mar 2028

Study Start

First participant enrolled

March 7, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

December 2, 2021

Last Update Submit

March 16, 2026

Conditions

Keywords

total joint arthroplastyperiprosthetic joint infectionsgenetic susceptibility

Outcome Measures

Primary Outcomes (1)

  • Genotyping

    Samples will undergo genetic testing to determine the presence or absence of potential candidate genes responsible for the increased incidence of PJI.

    DNA extraction and analysis will be performed immediately after collection of blood draw or saliva/cheek cell sample by a certified core lab

Study Arms (1)

Total Joint Arthroplasty (TJA)

Recruitment of families with an increased incidence of TJI with PJI.

Genetic: Blood Draw or Saliva/Cheek Cell Sample:

Interventions

Collected samples will immediately undergo genetic analysis to determine the presence or absence of potential candidate genes responsible for the increased incidence of PJI.

Also known as: Genetic sample
Total Joint Arthroplasty (TJA)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Family members (affected and unaffected) with an increased incidence of TJI with PJI.

You may qualify if:

  • Families/pedigrees which demonstrate a high-risk for PJI
  • Unaffected family members, up to 3rd degree

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Draw or Saliva/Cheek Cell Sample

MeSH Terms

Conditions

Genetic Predisposition to Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jeremy Gililland, M.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 16, 2021

Study Start

March 7, 2018

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations