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

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 Overview

• Status: Withdrawn
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Drug: Testosterone Therapy; Other: No Testosterone Therapy

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Des Plaines, Illinois, United States, 60018
      • American Hip Institute Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Testosterone Therapy	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).
PLACEBO_COMPARATOR: No Testosterone Therapy	Other: No Testosterone Therapy; For the sham procedure no pellets will be implanted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	patient-reported outcome measure	3 months
Visual Analog Scale	patient-reported outcome measure	1 year
Patient Satisfaction (reported from questionnaire)	patient-reported outcome measure	3 months
Patient Satisfaction (reported from questionnaire)	patient-reported outcome measure	1 year

Collaborators and Investigators

• Sponsor: American Hip Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No