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.
412 studies on the registry are indexed under Muscular Atrophy; 77 are open to participants now.
This study's planned enrollment of 15 is below the median of 40 across 326 interventional studies indexed under Muscular Atrophy.
Browse Muscular Atrophy studies →The Stone Research Foundation for Sports Medicine and Arthritis is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone undecanoate
The Stone Research Foundation for Sports Medicine and Arthritis