Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
Summary
- Conditions
- Complication of Surgical Procedure
- Knee Injuries and Disorders
- Muscle Atrophy
- Surgery
- Trauma
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Outcomes Assessor)Masking Description: Both the participant and analyzing MRI Radiologist will be blind.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Only males
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 past...
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.
Tracking Information
- NCT #
- NCT04456530
- Collaborators
- Not Provided
- Investigators
- Study Director: Mani Vessal, Ph.D. Stone Research Foundation