Testosterone Administration and ACL Reconstruction in Men (TACL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Southern California
Sponsor:
Collaborators:
Boston University
University of Oregon
Information provided by (Responsible Party):
Todd Schroeder, University of Southern California
ClinicalTrials.gov Identifier:
NCT01595581
First received: May 8, 2012
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Muscle Atrophy
ACL Reconstruction
Trauma
Osteoarthritis
Drug: Testosterone
Drug: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Changes in lean mass [ Time Frame: 6, 12 weeks ] [ Designated as safety issue: No ]
    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:
  • KOOS scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Changes in muscle strength and knee stability from the start of rehabilitation to 6 and 12 weeks following surgery between the two groups.


Estimated Enrollment: 14
Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595581

Contacts
Contact: Todd Schroeder, PhD (323) 442-2498 eschroed@usc.edu
Contact: Brian Wu (323) 442-2180 brianwwu@usc.edu

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Todd Schroeder, PhD    323-442-2498    eschroed@usc.edu   
Contact: Brian Wu    (323) 442 2180    brianwwu@usc.edu   
Principal Investigator: Todd Schroeder, PhD         
Sponsors and Collaborators
University of Southern California
Boston University
University of Oregon
  More Information

No publications provided

Responsible Party: Todd Schroeder, Assistant Professor of Clinical Physical Therapy, University of Southern California
ClinicalTrials.gov Identifier: NCT01595581     History of Changes
Other Study ID Numbers: HS-11-00649
Study First Received: May 8, 2012
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Testosterone
ACL Reconstruction
Clinical outcomes
Lean mass
Strength
Muscle atrophy

Additional relevant MeSH terms:
Muscular Atrophy
Osteoarthritis
Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014