Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears

Completed · Phase 2 · Has a placebo group

Conditions studied: Rupture of Anterior Cruciate Ligament

In brief

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.

Key facts

Study ID

NCT02420353

Run by

University of Michigan

People needed

20

Starts

2015-05-01

Expected to finish

2018-10-01

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older, up to 35. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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