Effects of Tranexamic Acid on Joint Health After ACL Injury
Novel Strategies to Combat Post-Traumatic Osteoarthritis (PTOA):The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
This study is testing whether Tranexamic Acid can help young adults with ACL injuries have better joint health and reduce inflammation after their injury.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT03552705 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Tranexamic Acid (TXA) on joint inflammation and cartilage health in patients who have suffered an anterior cruciate ligament (ACL) injury. TXA is an FDA-approved medication that reduces bleeding and may help prevent post-traumatic osteoarthritis (PTOA) by minimizing inflammation following ACL reconstruction. The study aims to enroll patients aged 18-30 who are within four days of their ACL injury and have joint effusion or hemarthrosis. Participants will receive either TXA or a placebo to assess the effectiveness of TXA in improving joint health.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-30 who have sustained a unilateral ACL injury within the last four days and exhibit joint effusion or hemarthrosis.
Not a fit: Patients with inflammatory arthritis, pre-existing osteoarthritis, or those requiring immediate surgical intervention for other knee injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing arthritis in young patients after ACL injuries.
How similar studies have performed: While the use of TXA in surgical settings is established, this specific application for preventing PTOA in ACL injuries is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-30 years * within 4 days of unilateral ACL injury * presence of effusion/hemarthrosis. Exclusion Criteria: * inflammatory arthritis, radiographic osteoarthritis (K-L Grade 2 or higher), gout/ pseudogout * systemic or acute illness requiring medications * concomitant knee injury aside from meniscus tear and MCL tear not requiring surgery * prior surgery to either knee * prior injury to either knee requiring crutches * history of thromboembolic disease * current use of combination hormonal contraception * chronic NSAID use * cortisone injection to either knee within the prior 3 months * not indicated for or unable to undergo ACLR within 3 months of injury
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Constance Chu, MD — Stanford University
- Study coordinator: Christine L Hoang, BS
- Email: c1hoang@stanford.edu
- Phone: 650-721-7612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.