Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
- Conditions
- Arthroplasty, Replacement, Hip
- Interventions
- Other: No Testosterone Therapy
- Registration Number
- NCT05722301
- Lead Sponsor
- American Hip Institute
- Brief Summary
This randomized-controlled trial will study on the effect of testosterone therapy on patients undergoing total hip replacement. Subjects will be male patients \> 50 years with testosterone deficiency undergoing total hip replacement due to severe degenerative joint disease. All participants will receive a total hip replacement and will be randomized to either testosterone therapy or placebo. A total of 80 subjects will be recruited randomized into 2 groups of 40 subjects. Testosterone therapy will be administered once to each patient at 2 weeks before surgery. The long-term follow up will be the same as all patients with patient-reported outcomes after total hip replacement, VAS for pain and satisfaction at regular intervals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- Male patients
- 50 years of age and older
- Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.
- History of prostate cancer less than 5 years ago or those men whom are not considered to be cancer free
- History of breast cancer less than 5 years ago or those men whom are not considered to be cancer free
- History of deep vein thrombosis (DVT)
- Presence of Factor V Leiden (as seen in labs)
- Presence of Protein S Deficiency (as seen in labs)
- History of atherosclerotic artery disease - by history having had a diagnosis made of CAD, MI, or stroke
- Liver disease (as viewed by liver function tests)
- Testosterone free level greater than 10pg/mL
- Hematocrit >51%; PSA >= 3ng/mL.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Testosterone Therapy Testosterone Therapy - No Testosterone Therapy No Testosterone Therapy -
- Primary Outcome Measures
Name Time Method Harris Hip Score 1 year patient-reported outcome measure
Forgotten Joint Score 1 year patient-reported outcome measure
- Secondary Outcome Measures
Name Time Method Patient Satisfaction (reported from questionnaire) 1 year patient-reported outcome measure
Visual Analog Scale 1 year patient-reported outcome measure
Trial Locations
- Locations (1)
American Hip Institute Research Foundation
🇺🇸Des Plaines, Illinois, United States