Status:
NOT_YET_RECRUITING
Peri-Operative Testosterone Administration in Primary Total Hip Arthroplasty
Lead Sponsor:
American Hip Institute
Conditions:
Osteoarthritis, Hip
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
It is often observed that patients following total hip replacement have a hard time with rehabilitation, as patients commonly lose muscle mass and strength around the surgical site. The goal of this s...
Detailed Description
The purpose of this double blinded, randomized controlled trial is to determine if weekly intramuscular testosterone administration can prevent short-term catabolic loss of lean mass in patients under...
Eligibility Criteria
Inclusion
- Male patients over the age of 18 with a diagnosis of osteoarthritis or dysplasia that are undergoing total hip replacement will be recruited to the study and screened for eligibility. Inclusion criteria include clinical diagnosis of osteoarthritis or dysplasia, age 18 and older, and hypogonadism, defined as a testosterone level \<300ng/dL or clinical signs of hypogonadism including reduced muscle mass and strength, decreased libido, erectile dysfunction, loss of body hair, low bone mineral density, infertility, gynecomastia, or incomplete or delayed sexual development.
Exclusion
- Major exclusion criteria include previous arthroplasty of the affected hip, previous spine surgery, a past medical history significant for allergy to testosterone, prostate cancer, PSA \>4 ng/ml, breast cancer, polycythemia, diabetes mellitus with a HbA1c \> 7, BMI \<18 or \> 40, and preoperative motion or strength limitations that will affect postoperative rehabilitation.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06608914
Start Date
January 1 2025
End Date
December 1 2026
Last Update
January 1 2025
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