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

University of Michigan

Status and phase

Completed

Phase 2

Conditions

Rupture of Anterior Cruciate Ligament

Treatments

Drug: Somatropin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02420353

HUM00087702

IND Exemption 123189 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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.