Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 11/24/2018 |
| Start Date: | May 2015 |
| End Date: | December 2020 |
Evaluation of Recombinant Growth Hormone Therapy to Prevent Muscle Atrophy in Patients With Anterior Cruciate Ligament Tears
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.
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.
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.
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Christopher L Mendias, PhD, ATC
Phone: 734-930-7386
University of Michigan The University of Michigan was founded in 1817 as one of the...
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