ACUTE ACL Clinical Trial: Immediate Treatment of ACL Injuries to Prevent Osteoarthritis
A Clinical Trial for Young Adults Ages 18-30 with New ACL Tears
Young people develop “old knees” after tearing the ACL
Within 10 years of ACL injury, about half of patients develop knee arthritis. The arthritis is called osteoarthritis, a disabling condition typically seen in old people who have knee pain, swelling and stiffness making it difficult or impossible to walk. Most people tearing the ACL are young and active, often teenage or college athletes who can then find themselves unexpectedly disabled early in life.
Osteoarthritis cannot be conventionally diagnosed until symptoms or x-ray changes appear and it is already too late to do anything to reverse its course, and there is currently no cure for osteoarthritis short of replacing the knee with metal and plastic. Consequently, Dr. Constance Chu has focused her research on new ways to identify “pre-osteoarthritis,” or signs of knee deterioration that occur before osteoarthritis even develops, as well as treatments that might prevent osteoarthritis.
How an ACL tear can cause osteoarthritis
When the ACL tears, it usually bleeds into the knee joint causing it to swell. The knee joint is not normally exposed to blood, and thus the bleeding triggers inflammation and other processes that can damage the joint cartilage. While outwardly, the knee may appear to recover and be symptom-free for years after, the inflammation and cartilage damage can persist and lead over time to osteoarthritis.
In an earlier award-winning series of more than 40 studies funded by the National Institutes of Health (NIH), Dr. Chu led research culminating in the development of a new MRI color mapping technique that can show early joint damage invisible to x-rays and standard MRIs. Through this new MRI technique, she found that nearly half of patients begin to develop “pre-osteoarthritis” just one to two years after ACL injury. This means that treatment may need to start as soon as the ACL injury occurs.
- Ages 18-30
- Within 4 days of ACL injury
- Presence of a swollen knee
- Intend to be treated at Stanford
If you or someone you know might be interested in participating in this study and want more information, call the ACL Research Hotline.
Participant’s rights questions, contact 1-866-680-2906
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About the ACUTE ACL clinical trial
In this study, Dr. Chu and her team will use an FDA-approved drug called tranexamic acid (TXA)—already widely used to reduce bleeding during orthopaedic surgeries—to see if TXA treatment right after ACL injury and during ACL surgery can improve knee recovery and cartilage health over 2 years of follow-up. This clinical trial is part of a $10 million grant led by Dr. Chu from the Department of Defense to combat the problem of osteoarthritis occurring after joint injuries.
Who is it for?
The trial is for adults ages 18-30 within four days of sustaining an ACL tear who intend to have their injury fully treated at Stanford Health Care.
Time since injury--4 days or less—is a critical prerequisite for participating in this trial.
Where is it being conducted?
Stanford University School of Medicine - Stanford Medicine Outpatient Center
450 Broadway Street
Redwood City, CA 94063
Participating in this double-blind, randomized control trial will require a series of visits, including the following:
- Blood will be drawn and fluid will be removed from the knee joint at the initial visit and one week after the initial visit following completion of TXA or placebo treatment.
Treatment (study volunteers will be randomly assigned to TXA or placebo) will include:
- Five day oral TXA or placebo on enrollment
- Intravenous TXA or placebo (according to the assignment on enrollment) during ACL reconstruction surgery
- Questionnaires, research knee color map MRIs at six weeks (as well as baseline x-ray), one year and two years after ACL reconstruction surgery
Participants will be compensated up to $375.
More information on clinical trial web page.
Clinical Research Coordinator
Clinical Research Coordinator Assistant
Constance R. Chu, MD
Orthopaedic Sports Medicine Surgeon
About Dr. Chu
Dr. Constance R. Chu is Professor and Vice Chair of Research, in the Department of Orthopaedic Surgery at Stanford University. She is also Director of the Joint Preservation Center and Chief of Sports Medicine at the VA Palo Alto.
Previously, she was the Albert Ferguson Endowed Chair and Professor of Orthopaedic Surgery at the University of Pittsburgh. She is a clinician-scientist who is both principal investigator of several projects funded by the National Institutes of Health and who has been recognized as a Castle-Connelly/US News and World Report “Top Doctor” in Orthopaedic Surgery as well as on Becker’s list of Top Knee Surgeons in the United States.
Her clinical practice focuses on the knee: primarily restoration and reconstruction of the ACL, menisci and cartilage. She graduated from the U.S. Military Academy at West Point and earned her medical degree from Harvard Medical School.