Anterior Cruciate Ligament Reconstruction
Conditions
Brief summary
Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.
Interventions
DRUGTranexamic Acid
5-day course of oral standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)
DRUGPlacebos
5-day course of oral placebo and intravenous saline during ACL reconstruction surgery
Sponsors
Stanford University
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blinded RCT
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Synovial fluid IL-1 | Day 5 | To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation |
| Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS) | 6 months post-ACLR | To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves PRO (KOOS Quality of Life) at 6 months after ACLR. The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses a patient's opinion about their knee and associated problems. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative MRI (qMRI) | 6 months post-ACLR | To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2\* at 6 months after ACLR |
| Quantitative MRI | 2 years post-ACLR | To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves cartilage subsurface matrix structure assessed by qMRI UTE-T2\* at 2 years after ACLR |
| Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS) | 2 years post-ACLR | To determine whether TXA administered acutely after ACL injury and during ACLR surgery improves PRO (KOOS Quality of Life) at 2 years after ACLR. The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses a patient's opinion about their knee and associated problems. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated. |
Countries
United States
Contacts
CONTACTChristine L Hoang, BS
PRINCIPAL_INVESTIGATORConstance Chu, MD
Stanford University
Outcome results
None listed