Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Testosterone Therapy
- Conditions
- Arthroplasty, Replacement, Hip
- Sponsor
- American Hip Institute
- Locations
- 1
- Primary Endpoint
- Harris Hip Score
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male patients
- •50 years of age and older
- •Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.
Exclusion Criteria
- •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.
Arms & Interventions
Testosterone Therapy
Intervention: Testosterone Therapy
No Testosterone Therapy
Intervention: No Testosterone Therapy
Outcomes
Primary Outcomes
Harris Hip Score
Time Frame: 1 year
patient-reported outcome measure
Forgotten Joint Score
Time Frame: 1 year
patient-reported outcome measure
Secondary Outcomes
- Visual Analog Scale(1 year)
- Patient Satisfaction (reported from questionnaire)(1 year)