Testosterone Levels and Cutibacterium

Conditions

• Arthroplasty, Replacement, Shoulder

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Jul 1, 2020

Status verified

Mar 2025

Primary completion

Jan 1, 2027

Completion

Jan 1, 2027

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Serum testosterone [ Time Frame: At pre-operative clinic appointment, typically within 30 days prior to surgery ]

Central Contacts

• Jason E Hsu, MD
  330-883-8829
  [email protected]
• Anastasia Whitson, BS
  206-755-7847
  [email protected]

Locations (1)

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