Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Drug: Testosterone Therapy
* Other: No Testosterone Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone Therapy<br> | Drug: Testosterone Therapy<br>* The testosterone pellet implantation will be performed 2 weeks before surgery. The dose is determined by baseline levels of sex hormone binding globulin (SHBG) in the following manner: If SHBG > 60nmol/L implant 5 Testosterone Compounded 200mg (total 1000mgs testosterone). If SHBG 41-59 nmol/L implant 4 Testosterone Compounded 200mg (total 800mgs testosterone). If SHBG <40 nmol/L implant 3 Testosterone Compounded 200mg (total 600mgs testosterone).<br>|
| Placebo Comparator: No Testosterone Therapy<br> | Other: No Testosterone Therapy<br>* For the sham procedure no pellets will be implanted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | patient-reported outcome measure | 3 months | 
| Harris Hip Score | patient-reported outcome measure | 1 year | 
| Forgotten Joint Score | patient-reported outcome measure | 3 months | 
| Forgotten Joint Score | patient-reported outcome measure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | patient-reported outcome measure | 3 months | 
| Visual Analog Scale | patient-reported outcome measure | 1 year | 
| Patient Satisfaction (reported from questionnaire) | patient-reported outcome measure | 3 months | 
| Patient Satisfaction (reported from questionnaire) | patient-reported outcome measure | 1 year |