| NCT ID | NCT05030220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Arthroplasty, Replacement, Shoulder |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-07-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jason E Hsu, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05030220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Arthroplasty, Replacement, Shoulder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05030220 currently recruiting?
Yes, NCT05030220 is actively recruiting participants. Contact the research team at jehsu@uw.edu for enrollment information.
Where is the NCT05030220 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05030220 clinical trial?
NCT05030220 is sponsored by University of Washington. The principal investigator is Jason E Hsu, MD at University of Washington. The trial plans to enroll 300 participants.