Clinical trial NCT01595581: Testosterone Administration and ACL Reconstruction in Men
Official title: The Effects of Acute Testosterone Administration in Men on Muscle Mass, Strength, and Physical Function Following ACL Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Muscle Atrophy
ACL Reconstruction
Trauma
Osteoarthritis
Keywords: Testosterone
ACL Reconstruction
Clinical outcomes
Lean mass
Strength
Muscle atrophy
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Boston University
name: University of Oregon
First posted: 2012-05-10
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Lean Mass
timeFrame: 6, 12, and 24 weeks post operative
Secondary outcomes:
measure: KOOS Scores
timeFrame: 6 weeks, 12 weeks, 24 weeks post surgery
measure: Strength
timeFrame: 6, 12, and 24 weeks post surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Todd Schroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.
citation: Wu BW, Berger M, Sum JC, Hatch GF 3rd, Schroeder ET. 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 Surg. 2014 Dec 6;14:102. doi: 10.1186/1471-2482-14-102.