NCT04456530

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Stone Research Foundation for Sports Medicine and Arthritis · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Muscle Atrophy
• Surgery
• Knee Injuries and Disorders
• Complication of Surgical Procedure
• Trauma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-08
• Primary completion: 2021-12-30
• Completion: 2022-06-30
• First posted: 2020-07-02
• Last updated: 2021-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study