Clinical trial NCT04456530: Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
Official title: Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Muscle Atrophy
Surgery
Knee Injuries and Disorders
Complication of Surgical Procedure
Trauma
Keywords: Surgery
Testosterone
Muscle atrophy
Post-operative rehabilitation
Lead sponsor: The Stone Research Foundation for Sports Medicine and Arthritis
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change in MRI Cross Sectional Area of the Quadriceps
timeFrame: Pre-operative and 1, 3, and 6 months post-operative
measure: Change in Manual Measurements of the Quadriceps
timeFrame: Pre-operative and 1, 3, and 6 months post-operative
Secondary outcomes:
measure: Change in Knee Pain and Function Survey, KOOS
timeFrame: Pre-operative and 1, 3, and 6 months post-operative
Other outcomes:
measure: Change in serum cortisol (mcg/dL) levels
timeFrame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
measure: Change in serum testosterone (ng/dL) levels
timeFrame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
measure: Change in serum prostate specific antigen (ng/mL) levels
timeFrame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
measure: Change in serum hepatic function panel (mg/dL) levels
timeFrame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
measure: Change in complete blood count with differential levels
timeFrame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Locations:
city: San Francisco
country: United States
facility: Stone Research Foundation
state: California
Study officials:
affiliation: Stone Research Foundation
name: Mani Vessal, Ph.D.
role: STUDY_DIRECTOR
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