Recruitment

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