A Phase 2/3 interventional study of Aveed 750 MG in 3 ML IM Injection and Normal Saline 3 ML IM Injection in Muscle Atrophy, Surgery and Knee Injuries and Disorders, sponsored by The Stone Research Foundation for Sports Medicine and Arthritis. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by The Stone Research Foundation for Sports Medicine and Arthritis · Phase 2/3, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Participants receiving two IM Testosterone injections.
Drug: Aveed 750 MG in 3 ML IM Injection
Participants receiving two IM Normal Saline Injections.
Other: Normal Saline 3 ML IM Injection
Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.
Participants in the Control Group will receive two IM normal saline injections 1 month apart.
Change in MRI Cross Sectional Area of the Quadriceps
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.
Time frame: Pre-operative and 1, 3, and 6 months post-operative
Change in Manual Measurements of the Quadriceps
Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape.
Time frame: Pre-operative and 1, 3, and 6 months post-operative
Change in Knee Pain and Function Survey, KOOS
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.
Time frame: Pre-operative and 1, 3, and 6 months post-operative
Change in serum cortisol (mcg/dL) levels
Laboratory blood analysis of cortisol will be performed for therapeutic assessment and safety.
Time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in serum testosterone (ng/dL) levels
Laboratory blood analysis of testosterone will be performed for therapeutic assessment and safety.
Time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in serum prostate specific antigen (ng/mL) levels
Laboratory blood analysis of PSA will be performed for therapeutic assessment and safety.
Time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in serum hepatic function panel (mg/dL) levels
Laboratory blood analysis of HFP will be performed for therapeutic assessment and safety.
Time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in complete blood count with differential levels
Laboratory blood analysis CBC w/ diff will be performed for therapeutic assessment and safety.
Time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
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The Stone Research Foundation for Sports Medicine and Arthritis