Testosterone Administration and ACL Reconstruction in Men
Condition: Muscle Atrophy; ACL Reconstruction; Trauma; Osteoarthritis
MeSH terms: Muscular Atrophy; Atrophy
Intervention: Testosterone; Placebo
Intervention description: 8 weeks of testosterone administration beginning 2 weeks before ACL surgery; 8 weeks of saline administration beginning 2 weeks before ACL surgery
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Testosterone; ACL Reconstruction; Clinical outcomes; Lean mass; Strength; Muscle atrophy

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.
    

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