Dave Bernholt
The goal of this clinical trial is to learn whether taking oral tranexamic acid (TXA) for one week after anterior cruciate ligament (ACL) reconstruction improves recovery in adolescents and young adults aged 14 to 25 years. All participants receive standard intravenous TXA during surgery. The main questions it aims to answer are: * Does oral TXA lower knee pain at 2 weeks after surgery? * Does oral TXA reduce the amount of opioid pain medicine used in the first 2 weeks? * Does oral TXA improve knee range of motion at 2 weeks? Researchers will compare oral TXA to a placebo (a look-alike capsule with no active drug) to see if oral TXA improves pain, opioid use, motion, strength, knee function, and return to sport. Participants will: * Take 3 capsules (oral TXA or placebo) once a day for the first 8 days after surgery (day of surgery through day 7) * Keep a home diary for 2 weeks recording pain scores, opioid pills taken and any side effects * Return for study visits at 2 weeks, 6 weeks, 12 weeks, 6 months, 9 months and 1 year for pain, motion, strength and function testing * Complete a survey at 2 years
This multicenter, investigator-initiated, randomized, double-blind, placebo-controlled trial is conducted under IND 177715 at the University of Cincinnati (coordinating center) and five U.S. academic sites. One hundred participants undergoing isolated primary ACL reconstruction with bone-patellar tendon-bone autograft will be randomized 1:1 at the conclusion of surgery to oral TXA 1.95 g (three 650 mg capsules) once daily or matching microcrystalline cellulose placebo on postoperative days 0 through 7. All participants receive 1 g IV TXA before incision and 1 g IV TXA at closure, plus a standa…
Inclusion Criteria: * Age 14 to 25 years with an ACL tear undergoing primary ACL reconstruction with bone-patellar tendon-bone autograft * Closed or closing proximal tibial and distal femoral physes on preoperative imaging (less than 1 year of growth remaining by MRI and radiographic bone age) * Weight of at least 100 lbs (45.4 kg) * Fluent in English Exclusion Criteria: * Revision ACL reconstruction, multiligament knee reconstruction, or concurrent lateral extra-articular tenodesis or anterolateral ligament reconstruction * Concomitant meniscal repair or cartilage procedure requiring non-w…
Compounded 650 mg oral capsules (USP-grade TXA, microcrystalline cellulose filler), 1.95 g once daily POD 0-7.
Matching capsules containing microcrystalline cellulose NF, three once daily POD 0-7.