A breakthrough could be coming in the way young people recover from surgery to reconstruct the anterior cruciate ligament (ACL) in the knee, a common sports injury.
A new clinical trial soon will begin enrolling patients at the University of Cincinnati to study extended postoperative use of the drug tranexamic acid (TXA), which helps reduce bleeding after surgery and may improve recovery outcomes.
More than 200,000 ACL reconstructions are performed in the United States each year, many in young athletes eager to return to play. The recovery process often takes nine to 12 months, and complications such as swelling, stiffness and loss of muscle strength can delay rehabilitation.
David Bernholt, MD, is the principal investigator of the study and an associate professor of clinical medicine in the Department of Orthopaedic Surgery in the Division of Sports Medicine.
“TXA is typically given intravenously during an ACL surgery to minimize blood loss,” said Bernholt. “This clinical trial will test the effects of extended dosing outside of the operating room. It will be prescribed orally for seven days after surgery.”
Bernholt noted that extended TXA dosing is now being used in joint replacement procedures due to recent studies showing improved results. This clinical trial will test whether similar benefits occur in ACL reconstructions.
“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.”
Clinical trial details
Bernholt is leading a multicenter, randomized, controlled trial in collaboration with the University of Pittsburgh, Duke University, Washington University in St. Louis, Endeavor Health in the Chicago area and Campbell Clinic in the Memphis area.
The sites will enroll a total of 100 participants between the ages of 14 and 22. Half will receive extended TXA dosing, while the other half will receive a placebo.
Eligible participants include high school and college athletes, recreational athletes, and others with ACL injuries caused by injuries or trauma. Patients who are interested in taking part in the trial should consult their orthopaedic surgeon.
Grant awarded
Bernholt recently received the Sandy Kirkley Clinical Outcomes Research Grant, valued at $25,000, from the American Orthopaedic Society for Sports Medicine (AOSSM) to support the clinical trial. One physician per year in the United States is selected for this award.
In 2021, Bernholt was awarded the Steven P. Arnoczky Young Investigator Grant from the AOSSM to support earlier research.
Potential impact
“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,” said Bernholt. “Patients’ muscle strength may not be impacted as much.”
Bernholt explained that extended TXA use could help prevent arthrogenic muscle inhibition (AMI), a physiological response that limits muscle activation after joint injury or surgery. AMI protects the joint but can also delay recovery.
“If patients can regain mobility more quickly, they may be cleared by a physician to return to their sport sooner,” he said. “With ACL injuries already requiring extended recovery, many student-athletes are eager to limit their rehabilitation time and return to competition.
Researchers will study participants’ one-year outcomes. Published results are expected in late 2027 or early 2028.