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

American Hip Institute

Status and phase: Withdrawn; Phase 3

Conditions: Arthroplasty, Replacement, Hip

Treatments: Other: No Testosterone Therapy; Drug: Testosterone Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05722301

2

Details and patient eligibility

About

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.

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Testosterone Therapy

Experimental group

Treatment:

Drug: Testosterone Therapy

No Testosterone Therapy

Placebo Comparator group

Treatment:

Other: No Testosterone Therapy