NCT05030220

Brief Summary

Phase 1: In 51 patients undergoing shoulder arthroplasties, total serum testosterone, free testosterone and sex hormone binding globulin levels obtained in the clinic before surgery were correlated with the levels of Cutibacterium on the skin in clinic, in the operating room prior to surgery, and in the skin incision. Phase 2: The investigators wish to determine if preoperative serum testosterone levels are associated with risk for shoulder PJI (periprosthetic joint infection) in patients undergoing primary shoulder arthroplasty. Also to determine if preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2020Jan 2027

Study Start

First participant enrolled

July 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

6.5 years

First QC Date

May 7, 2021

Last Update Submit

March 25, 2025

Conditions

Arthroplasty, Replacement, Shoulder

Keywords

TestosteroneCutibacteriumShoulder Arthroplasty

Outcome Measures

Primary Outcomes (8)

  • Serum testosterone

    At pre-operative clinic appointment, typically within 30 days prior to surgery

  • Free testosterone

    At pre-operative clinic appointment, typically within 30 days prior to surgery

  • sex hormone binding globulin

    At pre-operative clinic appointment, typically within 30 days prior to surgery

  • Cutibacterium specimen value

    Skin swab at pre-operative clinic appointment, typically within 30 days prior to surgery

  • Cutibacterium specimen value

    Skin swab immediately pre-operative

  • Cutibacterium specimen value

    Freshly incised dermis of surgical wound

  • Preoperative serum testosterone levels are associated with risk for shoulder PJI in patients undergoing primary shoulder arthroplasty.

    Up to 20 years after surgery

  • Preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty

    21 days after surgery

Study Arms (2)

Phase 1

51 subjects with serum levels of testosterone, free testosterone, and sex hormone binding globulin as well as the SpCuV from the cultures obtained in clinic, immediately pre-operative skin cultures, and incised wound cultures.

Phase 2

Subjects enrolled to help determine if preoperative serum testosterone levels are associated with risk for shoulder PJI in patients undergoing primary shoulder arthroplasty and if preoperative serum testosterone levels are predictive of bacterial load of deep tissue cultures taken at the time of revision shoulder arthroplasty in patients undergoing primary shoulder arthroplasty.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Phase 1 and 2: Subjects will be adult patients who present to the UWMC Bone \& Joint Center for pre-operative appointments for elective shoulder arthroplasty.

You may qualify if:

  • Patients having elective shoulder arthroplasty

You may not qualify if:

  • history of shoulder septic arthritis
  • antibiotic use within 3 months prior to surgery
  • recent treatment for acne
  • Lacked fluency in English
  • Patients having elective shoulder arthroplasty
  • Lacked fluency in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Study Officials

  • Jason E Hsu, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason E Hsu, MD

CONTACT

330-883-8829jehsu@uw.edu

Anastasia Whitson, BS

CONTACT

206-755-7847whitsa@uw.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine

Study Record Dates

First Submitted

May 7, 2021

First Posted

September 1, 2021

Study Start

July 1, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)