Peri-Operative Testosterone Administration in Primary Hip Arthroscopy

AHI-004

It is often observed that patients following hip surgery 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.

2024-08-01

2026-08-01

2026-12-01

Not yet recruiting

Early phase I

60

Inclusion Criteria: * Male patients over the age of 18 with a diagnosis of femoroacetabular impingement (FAI) with labral tear will be recruited to the study and screened for eligibility. Inclusion criteria include clinical diagnosis of FAI, age 18 and older, and hypogonadism, defined as a testosterone level \<300ng/dL. Exclusion Criteria: * . Major exclusion criteria include previous surgery to the affected hip or spine, LCEA \< 18, 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-06-17