Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) Pain scores
研究概览
简要总结
The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.
详细描述
Randomized controlled trial with 1:1 allocation, selected through computer-based randomization.
This study will review prospectively collected data, including patient demographic information, surgeon, use of oral tranexamic acid (TXA) or placebo regimen, and postoperative outcomes up to 3 months after surgery. Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication.
This will be a double blinded study, with both patient and surgeon blinded to study group.
6.0 TXA dosing protocol TXA day of surgery [All patients]
- Administer 1-gram IV TXA intraoperatively at the start of the case (hold for history of stent within 1 year of surgery)
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This will be a double blinded study, with both patient and surgeon blinded to study group.
Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
- •Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).
- •Male and female patient age 18-89
- •Primary diagnosis of knee osteoarthritis
排除标准
- •Revision TKA
- •No exclusion based on gender
- •Patients <18 and >89 years old
- •Exclusion for IV oral tranexamic acid (TXA):
- •TXA allergy - there are NO absolute contraindications for TXA use.
- •History of stent placed within one year of surgery - patient will receive topical TXA as an alternative.
- •Exclusion for oral TXA:
- •o Actively treated cancer or deep vein thrombosis (DVT)
- •Chronic opioid use (opioid use within the 4 weeks prior to surgery)
- •Allergies to nonsteroidal Anti-inflammatory drugs (NSAIDs) and acetaminophen
- •Patients with clinically significant drug interactions
- •Pre-existing neuropathy
- •Current or previous venous thrombosis (DVT or venous stasis disease)
- •Immuno-compromised secondary to medical condition
- •Immune-suppressive medications, chemotherapy
- •Pregnancy, breast feeding
- •History of pain catastrophizing. Major depressive disorder
- •History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- •Currently on a neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.].
- •Non-English speaking and reading patient populations
- •Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course.
研究组 & 干预措施
TXA
- 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.
干预措施: Tranexamic acid (Drug)
Placebo
- 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS) Pain scores
时间窗: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.
次要结局
- Ambulation Status(at 2, 6 and 12 week follow up visits)
- Range of Motion(at 2, 6 and 12 week follow up visits)
- Opioid consumption(POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days))
研究者
Matthew Grosso, MD
Director, Quality and Outcomes Research
Trinity Health Of New England