Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02420353 · ClinicalTrials.gov registry record · Phase 2
Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02420353: Completed Phase 2 study, sponsored by University of Michigan.
NCT02420353 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02420353, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.
Interventions
- DRUG Placebo
- DRUG Somatropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-10 |
| Phase | Phase 2 |
What the finished NCT02420353 record still lists
NCT02420353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02420353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02420353 about?
NCT02420353 is a clinical study titled "Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL 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 pa...
What is the current status of trial NCT02420353?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2015-05. Estimated completion is 2018-10.
What interventions are being tested in trial NCT02420353?
The interventions under investigation include: Placebo (DRUG), Somatropin (DRUG).
Who is sponsoring clinical trial NCT02420353?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02420353's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia