The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-30
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18-30 years
within 4 days of unilateral ACL injury
presence of effusion/hemarthrosis.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid
Drug5-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)
Placebos
Drug5-day course of oral placebo and intravenous saline during ACL reconstruction surgery
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Tranexamic AcidExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 52
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-ACLRSecondary outcomes
1
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-ACLR2
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-ACLR3
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.
Time frame
2 years post-ACLRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov