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Testosterone Administration and ACL Reconstruction in Men (TACL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01595581
Recruitment Status : Unknown
Verified December 2013 by Todd Schroeder, University of Southern California.
Recruitment status was:  Recruiting
First Posted : May 10, 2012
Last Update Posted : December 5, 2013
Boston University
University of Oregon
Information provided by (Responsible Party):
Todd Schroeder, University of Southern California

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Muscle Atrophy ACL Reconstruction Trauma Osteoarthritis Drug: Testosterone Drug: Saline Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (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
Study Start Date : April 2012
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Testosterone, standard-of-care rehabilitation Drug: Testosterone
8 weeks supraphysiologic dose testosterone enanthate

Placebo Comparator: Standard-of-care rehabilitation, Saline Drug: Saline
Placebo for 8 weeks

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A complete ACL tear as visualized on MRI
  • The ACL injury can be either "isolated" or combined with one or several of the following injuries visualized on MRI and/or arthroscopy:
  • a meniscus tear that is either left untreated or treated with a partial resection
  • a small, stable meniscus tear treated with fixation, but with the fixation not interfering with the rehabilitation protocol
  • cartilage changes verified on MRI with an arthroscopically determined intact surface.
  • A radiographic examination with normal joint status or combined with either one of the following findings:
  • a small-avulsed fragment located laterally, usually described as a Segond fracture, JSN grade 1 or osteophytes grade 1 as determined by the OARSI atlas15

Exclusion Criteria:

  • Previous major knee injury or knee surgery
  • Associated posterior cruciate ligament (PCL) or medical collateral ligament (MCL) injury grade III
  • Concomitant severe injury to contra-lateral knee
  • Injury to the lateral/posterolateral ligament complex with significantly increased laxity
  • Unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (we.e. bracing and limited range of motion) interferes with the rehabilitation protocol
  • Bi-compartmental extensive meniscus resections
  • Cartilage injury representing a full thickness loss down to bone
  • Total rupture of MCL/LCL as visualized on MRI.
  • History of deep vein thrombosis (DVT) or a disorder of the coagulative system
  • Claustrophobia
  • Prior or current use of anabolic steroids
  • General systemic disease affecting physical function
  • Chromosomal disorders
  • Medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors
  • Any other condition or treatment interfering with the completion of the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01595581

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Contact: Todd Schroeder, PhD (323) 442-2498
Contact: Brian Wu (323) 442-2180

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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Todd Schroeder, PhD    323-442-2498   
Contact: Brian Wu    (323) 442 2180   
Principal Investigator: Todd Schroeder, PhD         
Sponsors and Collaborators
University of Southern California
Boston University
University of Oregon
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Todd Schroeder, Assistant Professor of Clinical Physical Therapy, University of Southern California Identifier: NCT01595581    
Other Study ID Numbers: HS-11-00649
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013
Keywords provided by Todd Schroeder, University of Southern California:
ACL Reconstruction
Clinical outcomes
Lean mass
Muscle atrophy
Additional relevant MeSH terms:
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Muscular Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs