Testosterone Levels and Shoulder Arthroplasty Infection Risk
This observational study is looking at the connection between testosterone levels and a type of bacteria called *Cutibacterium* (often found on the skin) in people having shoulder replacement surgery (arthroplasty). Researchers want to see if your testosterone levels before surgery are linked to the amount of *Cutibacterium* on your skin and if these levels can predict the risk of infection after surgery. They will measure your total testosterone, free testosterone, and sex hormone binding globulin (a protein that carries hormones) from a blood sample taken before your surgery. This study is for people aged 18 to 89 who are having elective shoulder replacement surgery. The study aims to enroll 300 participants, but its current status is unclear.
- Study design
- This is an observational study that will involve up to 300 participants. It is not a randomized study, meaning participants are not assigned to different treatment groups.
- What's involved
- You would have a blood test and skin swabs taken at a pre-operative clinic appointment. Additional skin swabs would be taken immediately before and after your shoulder surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints (serum testosterone, free testosterone, and sex hormone binding globulin) are measured at a pre-operative clinic appointment, typically within 30 days prior to surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Testosterone Levels and Cutibacterium
At a glance
Conditions
NCT05030220
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Washington
Seattle, Washingtonstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jason E Hsu, MD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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Inclusion
Exclusion
What this trial measures
- Serum testosteroneAt pre-operative clinic appointment, typically within 30 days prior to surgery
- Free testosteroneAt pre-operative clinic appointment, typically within 30 days prior to surgery
- sex hormone binding globulinAt pre-operative clinic appointment, typically within 30 days prior to surgery
- Cutibacterium specimen valueSkin swab at pre-operative clinic appointment, typically within 30 days prior to surgery
- Cutibacterium specimen valueSkin swab immediately pre-operative
- Cutibacterium specimen valueFreshly 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 arthroplasty21 days after surgery