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

Phase 2RecruitingNCT03552705

Stanford University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anterior Cruciate Ligament Reconstruction

Interventions

Tranexamic 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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Synovial fluid IL-1

To determine whether TXA administered acutely after ACL injury reduces synovial fluid markers of inflammation and cartilage degradation

Time frame: 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.

Time frame: 6 months post-ACLR

Secondary Outcomes

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

Time frame: 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

Time frame: 2 years post-ACLR