Complication of Surgical Procedure, Knee Injuries and Disorders, Muscle Atrophy, Surgery, Trauma
Conditions
Keywords
Surgery, Testosterone, Muscle atrophy, Post-operative rehabilitation
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.
Interventions
DRUGAveed 750 MG in 3 ML IM Injection
Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.
OTHERNormal Saline 3 ML IM Injection
Participants in the Control Group will receive two IM normal saline injections 1 month apart.
Sponsors
The Stone Research Foundation for Sports Medicine and Arthritis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both the participant and analyzing MRI Radiologist will be blind.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in serum hepatic function panel (mg/dL) levels | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative | Laboratory blood analysis of HFP will be performed for therapeutic assessment and safety. |
| Change in serum cortisol (mcg/dL) levels | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative | Laboratory blood analysis of cortisol will be performed for therapeutic assessment and safety. |
| Change in complete blood count with differential levels | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative | Laboratory blood analysis CBC w/ diff will be performed for therapeutic assessment and safety. |
| Change in serum testosterone (ng/dL) levels | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative | Laboratory blood analysis of testosterone will be performed for therapeutic assessment and safety. |
| Change in serum prostate specific antigen (ng/mL) levels | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative | Laboratory blood analysis of PSA will be performed for therapeutic assessment and safety. |
Countries
United States
Outcome results
None listed