Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears
Condition: Rupture of Anterior Cruciate Ligament
MeSH terms: Muscular Atrophy; Atrophy; Rupture
Intervention: Somatropin; Placebo
Intervention description: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.; A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: muscle atrophy; growth hormone; ACL tear

Summary:

      Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries
      that occur in physically active individuals. Despite advances in minimally invasive surgical
      reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength
      can persist even after patients return to full activity and can place them at considerable
      risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic
      interventions to prevent muscle atrophy is needed to advance the care of patients who suffer
      from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an
      important role in promoting muscle growth and protecting muscle from atrophy. While GH
      therapy has shown promise in protecting immobilized muscle from various models of disuse
      atrophy, it remains unknown whether GH can help to restore strength and protect against the
      loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe
      return to play of patients that suffer ACL tears, and help to prevent the long-term OA and
      reduction in quality of life that occur after these traumatic knee injuries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males between the ages of 18 and 35

          -  Have acute unilateral complete ACL tears with or without bucket handle medial meniscus
             tears that occurred within the past 6 months

          -  Consent to undergo an ACL reconstruction by an orthopaedic surgeon using a patellar
             tendon or hamstring autograft

          -  Will be performing supervised post-operative rehabilitation at UMHS MedSport at
             Dominos Farms

        Exclusion Criteria:

          -  Patients who are undergoing a revision ACL reconstruction

          -  Had a previous injury to the involved knee

          -  Have an allergy to recombinant GH

          -  Have a BMI<20 or >35

          -  Have a growth disorder of bones or connective tissue, type 1 diabetes mellitus, type 2
             diabetes mellitus, or who have a history of carpal tunnel syndrome, trigger finger,
             myopathy, cancer, endocrine disorder, hypertension or rheumatologic disorder.

          -  Systolic blood pressure >140mm Hg or diastolic blood pressure >90mm Hg, or with
             resting heart rate >110 BPM or <40 BPM at screening.

          -  Additionally, because GH is currently listed as a banned substance by the World
             Anti-Doping Agency (WADA), National Collegiate Athletics Association (NCAA) and most
             professional sports agencies, we will exclude patients who are current collegiate,
             professional or elite athletes.