Trial | NCT04456530  Report issue

Official Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    15
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.
Study Started
May 08
2020
Primary Completion
Dec 30
2021
Anticipated
Study Completion
Jun 30
2022
Anticipated
Last Update
Aug 31
2021

Drug Aveed 750 MG in 3 ML IM Injection

Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.

Other Normal Saline 3 ML IM Injection

Participants in the Control Group will receive two IM normal saline injections 1 month apart.

Testosterone Group Experimental

Participants receiving two IM Testosterone injections.

Control Group Placebo Comparator

Participants receiving two IM Normal Saline Injections.

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.
No Results Posted