Testosterone Administration and ACL Reconstruction in Men (TACL)
Recruitment status was: Recruiting
This study is being done to test whether taking testosterone can prevent loss of muscle mass and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential for the development of male reproductive tissues and promotes increased muscle, bone mass, and the growth of body hair.
The investigators hope to learn whether testosterone given before and after ACL reconstructive surgery will increase muscle mass and strength and potentially improve recovery time following surgery.
|Muscle Atrophy ACL Reconstruction Trauma Osteoarthritis||Drug: Testosterone Drug: Saline||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery|
- Changes in lean mass [ Time Frame: 6, 12 weeks ]Relative changes in lean mass from 2 weeks prior to surgery to multiple time points (1 day prior to surgery, and 6 and 12 weeks following surgery) between the two groups.
- KOOS scores [ Time Frame: 12 weeks ]Change in KOOS score from 2 weeks prior to surgery to 12 weeks following surgery between the two groups.
- Strength [ Time Frame: 6, 12 weeks ]Changes in muscle strength and knee stability from the start of rehabilitation to 6 and 12 weeks following surgery between the two groups.
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Experimental: Testosterone, standard-of-care rehabilitation||
8 weeks supraphysiologic dose testosterone enanthate
|Placebo Comparator: Standard-of-care rehabilitation, Saline||
Placebo for 8 weeks
Overall Objective: The overall objective of this study is to determine if 8 weeks of testosterone first administered 2 weeks prior to surgery, can improve the outcome of anterior cruciate ligament (ACL) reconstruction.
Overall Hypothesis: Standard-of-care rehabilitation with the addition of testosterone administration will augment muscle mass, strength, and physical function following ACL reconstructive surgery compared to standard rehabilitation alone.
Significance: Muscle mass and strength are greatly reduced following ACL surgery. The investigators hypothesize that administration of testosterone will minimize these reductions or potentially increase muscle mass and strength. In doing so, testosterone may hasten a patient's return to physical activity. If testosterone improves recovery after ACL surgery, the same treatment may be used for other injuries that involve trauma and muscle atrophy. Furthermore, this study will examine the effect of trauma with or without testosterone on myogenic regulators in muscle tissue taken during ACL surgery—providing possible mechanistic insights for the clinical outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595581
|Contact: Todd Schroeder, PhD||(323) firstname.lastname@example.org|
|Contact: Brian Wu||(323) email@example.com|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Todd Schroeder, PhD 323-442-2498 firstname.lastname@example.org|
|Contact: Brian Wu (323) 442 2180 email@example.com|
|Principal Investigator: Todd Schroeder, PhD|