Phase 2
N=20
Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears
Rupture of Anterior Cruciate Ligament
Bottom Line
View on ClinicalTrials.gov: NCT02420353 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op — 0.881; 0.681 Nm — p=0.0498
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Somatropin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Michigan
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op |
0.881; 0.681 | 0.0498 sig |
| SECONDARY Normative Isokinetic Extension (Nm) at Pre-op (Baseline) |
0.746; 0.816 | 0.7024 |
| SECONDARY Normative Isokinetic Flexion (Nm) at Pre-op (Baseline) |
0.738; 0.92 | 0.135 |
| SECONDARY Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op |
1.068; 1.028 | 0.6836 |
| SECONDARY Normative Isometric Extension (Nm) at Pre-op (Baseline) |
0.761; 0.778 | 0.9271 |
| SECONDARY Normative Isometric Extension (Nm) at 26 Weeks Post-op |
0.718; 0.633 | 0.1576 |
| SECONDARY Normative Isometric Flexion (Nm) at Pre-op (Baseline) |
0.771; 0.867 | 0.5586 |
| SECONDARY Normative Isometric Flexion (Nm) at 26 Weeks Post-op |
1.017; 0.954 | 0.45 |
| SECONDARY Absolute Isokinetic Extension (Nm) at Pre-op (Baseline) |
127.9; 124.7 | 0.8573 |
| SECONDARY Absolute Isokinetic Extension (Nm) at 26 wk Post-op |
140.1; 105.6 | 0.0564 |
| SECONDARY Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline) |
74.7; 77.5 | 0.7883 |
| SECONDARY Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op |
103.9; 86.2 | 0.0901 |
| SECONDARY Absolute Isometric Extension (Nm) at Pre-op (Baseline) |
183.1; 172.1 | 0.6292 |
| SECONDARY Absolute Isometric Extension (Nm) at 26 Weeks Post-op |
172.4; 140.3 | 0.161 |
| SECONDARY Absolute Isometric Flexion (Nm) at Pre-op (Baseline) |
69.2; 77.2 | 0.4437 |
| SECONDARY Absolute Isometric Flexion (Nm) at 26 Weeks Post-op |
84.6; 88.1 | 0.7325 |
| SECONDARY VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline) |
46.5; 45.1 | 0.6291 |
| SECONDARY VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op |
52.9; 50.2 | 0.3332 |
| SECONDARY VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline) |
54.6; 55.6 | 0.79 |
| SECONDARY VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op |
56.7; 59.3 | 0.4965 |
| SECONDARY International Knee Document Committee (IKDC) at Pre-op (Baseline) |
54.6; 55.6 | 0.1331 |
| SECONDARY International Knee Documentation Committee (IKDC) up to 26 wk Post-op |
65; 67 | 0.5251 |
| SECONDARY The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op |
98; 98.0 | 0.1064 |
| SECONDARY KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline) |
88; 91 | 0.4852 |
| SECONDARY KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op |
91; 92 | 0.7943 |
| SECONDARY KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline) |
74; 83 | 0.0894 |
| SECONDARY KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op |
53; 63 | 0.0673 |
| SECONDARY KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline) |
33; 47 | 0.0185 sig |
| SECONDARY KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op |
67.5; 72.2 | 0.6094 |
| SECONDARY KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline) |
46.5; 55.6 | 0.3279 |
| SECONDARY KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op |
60; 68 | 0.2802 |
| SECONDARY KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline) |
53; 64 | 0.1064 |
| SECONDARY Absolute Quadriceps Volume (L) at Pre-op (Baseline) |
2.48; 2.12 | 0.0509 |
| SECONDARY Absolute Quadricep Volume (L) at 26 Week Post-op |
2.27; 2.12 | 0.1605 |
| SECONDARY Absolute Hamstring Volume (L) at Pre-op (Baseline) |
1; 0.88 | 0.0357 sig |
| SECONDARY Absolute Hamstring Volume (L) at 26 Weeks Post-op |
0.98; 0.88 | 0.0122 sig |
| SECONDARY Normalized Quadriceps Volume (L) at Pre-op (Baseline) |
1; 0.85 | 0.5853 |
| SECONDARY Normalized Quadriceps Volume (L) at 26 Weeks Post-op |
0.91; 0.85 | 0.6288 |
| SECONDARY Normalized Hamstring Volume (L) at Pre-op (Baseline) |
1.06; 0.93 | 0.5022 |
| SECONDARY Normalized Hamstring Volume (L) at 26 Weeks Post-op |
1.03; 0.93 | 0.7507 |
| SECONDARY Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op |
22478; 10626 | <.0001 sig |
| SECONDARY Myostatin at -1 and 5 Weeks Post-op |
190.7; 193.6 | 0.8581 |
| SECONDARY MMP3 at -1 and 5 Weeks Post-op |
1188; 766 | 0.0208 sig |
| SECONDARY Hyaluronic Acid at -1 and 5 Weeks Post-op |
190.7; 193.6 | 0.8581 |
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 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.
Data sourced from ClinicalTrials.gov (NCT02420353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.