Testosterone Levels and Cutibacterium
ConditionArthroplasty, Replacement, Shoulder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorUniversity of Washington
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients having elective shoulder arthroplasty
Disqualifiers
history of shoulder septic arthritis
antibiotic use within 3 months prior to surgery
recent treatment for acne
Lacked fluency in English
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Phase 1
Group B: Phase 2
Trial outcomes
Primary outcomes
1
Serum testosterone
Time frame
At pre-operative clinic appointment, typically within 30 days prior to surgery2
Free testosterone
Time frame
At pre-operative clinic appointment, typically within 30 days prior to surgery3
sex hormone binding globulin
Time frame
At pre-operative clinic appointment, typically within 30 days prior to surgery4
Cutibacterium specimen value
Time frame
Skin swab at pre-operative clinic appointment, typically within 30 days prior to surgerySponsors and contacts
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Source ClinicalTrials.gov