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

• Status: Enrolling by invitation
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Stone Research Foundation for Sports Medicine and Arthritis

Criteria

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.