University of Cincinnati Leads Multicenter Trial Testing Extended Tranexamic Acid for ACL Surgery Recovery
Key Insights
The University of Cincinnati is leading a multicenter clinical trial to test extended oral tranexamic acid (TXA (search)) dosing for seven days after ACL reconstruction surgery to improve recovery outcomes.
The randomized controlled trial will enroll 100 participants aged 14-22 across six medical centers, comparing extended TXA (search) treatment to placebo for post-surgical recovery.
Extended TXA (search) dosing has shown improved results in joint replacement procedures and may reduce pain, swelling, and promote earlier movement in ACL patients.
The University of Cincinnati is spearheading a groundbreaking multicenter clinical trial to evaluate whether extended use of tranexamic acid (TXA (search)) can significantly improve recovery outcomes for young athletes undergoing ACL reconstruction surgery. The study represents a potential paradigm shift in post-operative care for one of the most common sports injuries affecting over 200,000 Americans annually.
Dr. David Bernholt, principal investigator and associate professor of clinical medicine in the Department of Orthopaedic Surgery's Division of Sports Medicine, is leading the randomized controlled trial that will test oral TXA (search) administration for seven days following surgery. "TXA is typically given intravenously during an ACL surgery to minimize blood loss," Bernholt explained. "This clinical trial will test the effects of extended dosing outside of the operating room."
Trial Design and Scope
The multicenter study involves collaboration between the University of Cincinnati, University of Pittsburgh, Duke University (search), Washington University in St. Louis, Endeavor Health (search) in the Chicago area, and Campbell Clinic in the Memphis area. The trial will enroll 100 participants between ages 14 and 22, with half receiving extended TXA (search) dosing and the other half receiving placebo treatment.
Eligible participants include high school and college athletes, recreational athletes, and others with ACL injuries caused by trauma. The study targets a critical demographic, as many young athletes face the challenging prospect of a 9-12 month recovery period that can significantly impact their athletic careers and academic pursuits.
Scientific Rationale and Potential Benefits
The trial builds on promising results from joint replacement procedures, where extended TXA (search) dosing has demonstrated improved outcomes. Bernholt noted that complications such as swelling, stiffness, and loss of muscle strength frequently delay ACL rehabilitation, making any intervention that addresses these issues potentially transformative.
"This could be a game changer," said Bernholt. "Anything we can do to reduce pain, decrease swelling and promote earlier movement in patients is critical."
The research team hypothesizes that extended TXA (search) use could help prevent arthrogenic muscle inhibition (search) (AMI), a physiological response that limits muscle activation after joint injury or surgery. While AMI serves a protective function for the joint, it can also significantly delay recovery progress.
Expected Outcomes and Timeline
Researchers anticipate that quicker improvements in pain and range of motion could lead to earlier progress in physical therapy and overall faster recovery. "We are optimistic that quicker improvements in pain and range of motion can lead to earlier progress in physical therapy, which may in turn lead to an overall quicker recovery," Bernholt explained. "Patients' muscle strength may not be impacted as much."
The potential for accelerated recovery holds particular significance for student-athletes who are eager to return to competition. "If patients can regain mobility more quickly, they may be cleared by a physician to return to their sport sooner," Bernholt noted. "With ACL injuries already requiring extended recovery, many student-athletes are eager to limit their rehabilitation time and return to competition."
Funding and Recognition
The trial has received substantial recognition within the orthopedic community. Bernholt recently received the Sandy Kirkley Clinical Outcomes Research Grant, valued at $25,000, from the American Orthopaedic Society for Sports Medicine (search) (AOSSM) to support the clinical trial. This prestigious award is given to only one physician per year in the United States. Additionally, Bernholt was previously awarded the Steven P. Arnoczky Young Investigator Grant from the AOSSM in 2021 for earlier research.
The study will track participants' outcomes over one year, with published results expected in late 2027 or early 2028. Patients interested in participating should consult with their orthopedic surgeon to determine eligibility for this potentially practice-changing trial.
