Arthroplasty, Replacement, Hip
Conditions
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.
Interventions
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).
OTHERNo Testosterone Therapy
For the sham procedure no pellets will be implanted.
Sponsors
American Hip Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 3 months | patient-reported outcome measure |
| Forgotten Joint Score | 3 months | patient-reported outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 3 months | patient-reported outcome measure |
| Patient Satisfaction (reported from questionnaire) | 3 months | patient-reported outcome measure |
Countries
United States
Outcome results
None listed