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

American Hip Institute

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Arthroplasty, Replacement, Hip

Interventions

Testosterone TherapyDRUG

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).

No Testosterone TherapyOTHER

For the sham procedure no pellets will be implanted.

Eligibility

Sex: MALEMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

American Hip Institute Research Foundation

Des Plaines, Illinois, United States