Testosterone Levels and Cutibacterium

Association Between Serum Testosterone Levels and Cutibacterium Culture Positivity During Shoulder Arthroplasty

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty, Replacement, Shoulder

Detailed Description

Phase 1: 51 patients having elective shoulder arthroplasty were offered the opportunity to participate, consented and enrolled in this prospective clinical cohort study.

At a preoperative clinic visit, basic demographic information was collected along with the patient's response to a question about taking supplemental testosterone. A swab of the unprepared skin over the area of the intended surgical incision was obtained and sent for culture. At this clinic visit, a sample of the patient's blood was also obtained and submitted to our clinical laboratory for the levels of total serum testosterone, sec hormone binding globulin (SHBG), and free testosterone.

Immediately before surgery, another swab of the unprepared skin over the area of the intended surgical incision was once again obtained and sent for culture. After incision, a swab of the freshly incised dermis was obtained and sent for culture.

All 3 swabs that were obtained were observed for 21 days. The investigators analyzed the cultures to determine the presence and load of bacteria using a semiquantitative method, known as the Cutibacterium specimen value (SpCuV)

Phase 2: This phase will also involve a onetime pre-operative testosterone serum test. If the subject consents to participate, this additional sample of blood will be collected for a testosterone serum test during the routine pre-operative blood draw that all patients have before a shoulder arthroplasty regardless of research participation. The investigators will include cultures such as skin swabs taken at pre-operative clinic appointments, skin swabs taken at the time of surgery, incision swabs taken at the time of surgery, and discarded tissue from surgery using our standard protocol for specimens. For this study's outcome measures, the investigators will record the culture results from those clinical specimens and compare them to the testosterone serum test. Some subjects may also be a part of a long term follow-up study and the follow-up data (self-reported outcome measures, etc.) from that study will be included for analysis for those patients.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Jason E Hsu, MD; Phone Number: 330-883-8829; Email: jehsu@uw.edu
• Study Contact Backup: Name: Anastasia Whitson, BS; Phone Number: 206-755-7847; Email: whitsa@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Jason Hsu, MD; Email: jehsu@uw.edu
      • Contact: Anastasia Whitson, BS; Email: whitsa@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Phase 1 Inclusion Criteria:

• Patients having elective shoulder arthroplasty

Phase 1 Exclusion Criteria:

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

Phase 2 Inclusion Criteria:

• Patients having elective shoulder arthroplasty

Phase 2 Exclusion Criteria:

• Lacked fluency in English

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Jason E Hsu, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: August 29, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Shoulder Arthroplasty; Testosterone; Cutibacterium
• Other Study ID Numbers: STUDY00009200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No