The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid<br>5-day course of 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) | Drug: Tranexamic Acid<br>* 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)<br>|
| Placebo Comparator: Placebo<br>5-day course of placebo and intravenous saline during ACL reconstruction surgery | Drug: Placebos<br>* 5-day course of oral placebo and intravenous saline during ACL reconstruction surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Synovial fluid IL-1 | To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation | Day 5 | 
| Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS) | 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. | 6 months post-ACLR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative MRI (qMRI) | 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 | 6 months post-ACLR | 
| Quantitative MRI | 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 | 2 years post-ACLR | 
| Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS) | 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. | 2 years post-ACLR |