Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study

Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study

The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. Although the use of testosterone in aging and chronic muscle loss has been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM) testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and manual measurements of quadriceps cross-section.

This is an in vivo study using serial IM testosterone undeconate injections in participants undergoing knee surgery with limited weight bearing post-operatively which includes partial/total knee replacement, ACL reconstruction/revision, meniscal allograft transplantation and articular cartilage paste grafting. The design is a randomized, controlled, double blind, longitudinal study of intra-muscular injections of testosterone versus saline control. Pre-operative and post-operative assessments will include: serial MRIs and manual measurements of quadriceps cross-section and knee pain and function survey, KOOS. Blood analysis will be performed for therapeutic assessment and safety. The participant will receive two testosterone undeconate injections, once during their pre-operative visit and once during their 1 month visit. Timing of assessments will be pre-operative, 1-4 days post-operative and 1, 3, and 6 months. Measurement of the control group versus experimental group at all time points may identify differences in participant response to testosterone injections.

Inclusion Criteria:

• Males age 18-65.
• Undergoing significant knee surgery such as partial/total knee replacement, ligament reconstruction, meniscus surgeries or articular cartilage paste grafting.

Exclusion Criteria:

• Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
• Men with BMI > 30 and Type I or II diabetes diagnosis
• Men prone to deep vein thrombosis or sleep apnea.
• Men with pre-existing hematocrit abnormalities.
• Men with pre-existing cardiac, renal, hepatic disease.
• Men who are taking insulin, medicines that decrease blood clotting or corticosteroids.
• Men with known hypersensitivity to testosterone undecanoate or any of its formulation ingredients (testosterone, refined castor oil, benzyl benzoate).
• Subject's unable or unwilling to comply with the protocol.
• Subject's unable to provide informed consent.
• Subject's unable to understand verbal and/or written English.