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Peri-Operative Testosterone Administration in Primary Total Hip Arthroplasty

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Nov 2024 to Jan 2025v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 study is to learn if giving patients testosterone around their hip surgery can prevent them from losing muscle mass, as well as to see if it will improve their outcomes after surgery. The main question this study aims to answer is: Will perioperative testosterone administration increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo? Researchers will compare patients who were administered testosterone to standard of care (no administration of testosterone) to see if there is a difference in their recovery and outcomes. Participants will be given either testosterone or saline for eight weeks beginning two weeks prior to surgery. Participants will have to answer questionnaires on how they are doing, as well as will do other testing during this time.
Trial Details
NCT Number NCT06608914
Lead Sponsor American Hip Institute
Conditions
(from sponsor)
Osteoarthritis, Hip
Related terms Hypogonadism, Osteoarthritis, Hip
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov