Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Testosterone Therapy
|
Drug: Testosterone Therapy
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).
|
| Placebo Comparator: No Testosterone Therapy
|
Other: No Testosterone Therapy
For the sham procedure no pellets will be implanted.
|
Outcome Measures
Primary Outcome Measures
- Harris Hip Score [3 months]
patient-reported outcome measure
- Harris Hip Score [1 year]
patient-reported outcome measure
- Forgotten Joint Score [3 months]
patient-reported outcome measure
- Forgotten Joint Score [1 year]
patient-reported outcome measure
Secondary Outcome Measures
- Visual Analog Scale [3 months]
patient-reported outcome measure
- Visual Analog Scale [1 year]
patient-reported outcome measure
- Patient Satisfaction (reported from questionnaire) [3 months]
patient-reported outcome measure
- Patient Satisfaction (reported from questionnaire) [1 year]
patient-reported outcome measure
Eligibility Criteria
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
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History of breast cancer less than 5 years ago or those men whom are not considered to be cancer free
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History of deep vein thrombosis (DVT)
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Presence of Factor V Leiden (as seen in labs)
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Presence of Protein S Deficiency (as seen in labs)
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History of atherosclerotic artery disease - by history having had a diagnosis made of CAD, MI, or stroke
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Liver disease (as viewed by liver function tests)
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Testosterone free level greater than 10pg/mL
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Hematocrit >51%; PSA >= 3ng/mL.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | American Hip Institute Research Foundation | Des Plaines | Illinois | United States | 60018 |
Sponsors and Collaborators
- American Hip Institute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2