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

Phase 2

• Conditions: Muscle Atrophy; Surgery; Trauma; Knee Injuries and Disorders; Complication of Surgical Procedure
• Interventions: Drug: Aveed 750 MG in 3 ML IM Injection; Other: Normal Saline 3 ML IM Injection

• Registration Number: NCT04456530
• Lead Sponsor: The Stone Research Foundation for Sports Medicine and Arthritis

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.

Study Timeline

• Study Start: 2020-05-08
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2021-12-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone Group	Aveed 750 MG in 3 ML IM Injection	Participants receiving two IM Testosterone injections.
Control Group	Normal Saline 3 ML IM Injection	Participants receiving two IM Normal Saline Injections.

Primary Outcome Measures

Name	Time	Method
Change in Manual Measurements of the Quadriceps	Pre-operative and 1, 3, and 6 months post-operative	Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape.
Change in MRI Cross Sectional Area of the Quadriceps	Pre-operative and 1, 3, and 6 months post-operative	T1 Axial and Sagittal planes will be obtained using a ONI 1.0T extremity MRI. Axial Cross sectional Area (cm\^2) will be measured of the Quadriceps muscle.

Secondary Outcome Measures

Name	Time	Method
Change in Knee Pain and Function Survey, KOOS	Pre-operative and 1, 3, and 6 months post-operative	Evaluate the knee pain and function of subjects as measures by the KOOS assessment.; Sections: 1. Pain; 2. Symptoms; 3. Activities of Daily Living; 4. Sports and Recreation; 5. Quality of Life; Scoring: Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.

Trial Locations

Locations (1)

Stone Research Foundation; 🇺🇸 San Francisco, California, United States