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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05722301
• Other study ID #: 2
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2023
• Source: American Hip Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

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).

Other:
• No Testosterone Therapy
For the sham procedure no pellets will be implanted.

Locations

Country	Name	City	State
United States	American Hip Institute Research Foundation	Des Plaines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
American Hip Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score	patient-reported outcome measure	3 months
Primary	Harris Hip Score	patient-reported outcome measure	1 year
Primary	Forgotten Joint Score	patient-reported outcome measure	3 months
Primary	Forgotten Joint Score	patient-reported outcome measure	1 year
Secondary	Visual Analog Scale	patient-reported outcome measure	3 months
Secondary	Visual Analog Scale	patient-reported outcome measure	1 year
Secondary	Patient Satisfaction (reported from questionnaire)	patient-reported outcome measure	3 months
Secondary	Patient Satisfaction (reported from questionnaire)	patient-reported outcome measure	1 year