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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone Therapy | Experimental |
| |
| No Testosterone Therapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Therapy | Drug | 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | patient-reported outcome measure | 3 months |
| Visual Analog Scale | patient-reported outcome measure | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Hip Institute Research Foundation | Des Plaines | Illinois | 60018 | United States |
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| No Testosterone Therapy | Other | For the sham procedure no pellets will be implanted. |
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| Patient Satisfaction (reported from questionnaire) | patient-reported outcome measure | 3 months |
| Patient Satisfaction (reported from questionnaire) | patient-reported outcome measure | 1 year |