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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Synovial fluid IL-1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blinded RCT
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-30 years
- •within 4 days of unilateral ACL injury
- •presence of effusion/hemarthrosis.
排除标准
- •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
研究组 & 干预措施
Tranexamic Acid
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)
干预措施: Tranexamic Acid (Drug)
Placebo
5-day course of placebo and intravenous saline during ACL reconstruction surgery
干预措施: Placebos (Drug)
结局指标
主要结局
Synovial fluid IL-1
时间窗: 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)
时间窗: 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.
次要结局
- Quantitative MRI(2 years post-ACLR)
- Patient-Reported Outcomes (PRO): Knee injury and Osteoarthritis Outcome Score (KOOS)(2 years post-ACLR)
- Quantitative MRI (qMRI)(6 months post-ACLR)
研究者
Constance R. Chu, MD
Principal Investigator
Stanford University