Randomized control trial to evaluate the effects of acute testosterone administration in men on muscle mass, strength, and physical function following ACL reconstructive surgery: rationale, design, methods

BMC Surgery

E Todd Schroeder²  George F Hatch¹  Jonathan C Sum²  Max Berger¹  Brian W Wu² 

[1] Keck School of Medicine, University of Southern California, Los Angeles, CA, USA;Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA

关键词: Orthopedic surgery;    Testosterone;    Rehabilitation;    Anterior cruciate ligament;   

Others  :  1090976
DOI  :  10.1186/1471-2482-14-102

 received in 2014-08-28, accepted in 2014-12-01,  发布年份 2014

【 摘 要 】

Background

The anterior cruciate ligament (ACL) is one of four major ligaments in the knee that provide stability during physical activity. A tear in the ACL is characterized by joint instability that leads to decreased activity, knee dysfunction, reduced quality of life and a loss of muscle mass and strength. While rehabilitation is the standard-of-care for return to daily function, additional surgical reconstruction can provide individuals with an opportunity to return to sports and strenuous physical activity. Over 200,000 ACL reconstructions are performed in the United States each year, and rehabilitation following surgery is slow and expensive. One possible method to improve the recovery process is the use of intramuscular testosterone, which has been shown to increase muscle mass and strength independent of exercise. With short-term use of supraphysiologic doses of testosterone, we hope to reduce loss of muscle mass and strength and minimize loss of physical function following ACL reconstruction compared to standard-of-care alone.

Methods/design

This study is a double-blinded randomized control trial. Men 18–50 years of age, scheduled for ACL reconstruction are randomized into two groups. Participants randomized to the testosterone group receive intramuscular testosterone administration once per week for 8 weeks starting 2 weeks prior to surgery. Participants randomized to the control group receive a saline placebo intramuscularly instead of testosterone. Lean mass, muscle strength and physical function are measured at 5 time points: 2 weeks pre-surgery, 1 day pre-surgery, and 6, 12, 24 weeks post-surgery. Both groups follow standard-of-care rehabilitation protocol.

Discussion

We believe that testosterone therapy will help reduce the loss of muscle mass and strength experienced after ACL injury and reconstruction. Hopefully this will provide a way to shorten the rehabilitation necessary following ACL reconstruction. If successful, testosterone therapy may also be used for other injuries involving trauma and muscle atrophy.

Trial registration

NCT01595581, Registration: May 8, 2012

【 授权许可】

   
2014 Wu et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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