The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
170
Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.
Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.
6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively. Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Time frame: At 6 weeks from timing of surgical intervention
2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 2 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Time frame: At 2 weeks from timing of surgical intervention
12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 12 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Time frame: At 12 weeks from timing of surgical intervention
2-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 2 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Time frame: At 2 weeks from timing of surgical intervention
6-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 6 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Time frame: At 6 weeks from timing of surgical intervention
12-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 12 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Time frame: At 12 weeks from timing of surgical intervention
6-week absolute knee flexion
Degrees of knee flexion achieved at the 6 week post-operative mark for patients undergoing Total Knee Arthroplasty
Time frame: At 6 weeks from timing of surgical intervention
Transfusion rate
Percentage of patients per arm requiring post-operative transfusion of blood products
Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Blood product units transfused
For each arm, the average number of blood product units transfused per patient
Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Incidence of Symptomatic DVT
The number of post-operative symptomatic deep vein thromboses identified in each arm
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Symptomatic PE
The number of post-operative symptomatic pulmonary embolisms identified in each arm
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Acute Coronary Sndrome
The number of cases of post-operative acute coronary syndrome, defined as an ST-elevation myocardial infarction (STEMI), a non-ST-elevation myocardial infarction (NSTEMI), or unstable angina.
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Incidence of Cerebrovascular Accident
The number of post-operative cerebrovascular accidents (CVAs), defined as ischemic or hemorrhagic stroke.
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
Rate of Readmission
The number of patients per arm requiring readmission for any reason within 90 days of surgical intervention.
Time frame: From enrollment to end of treatment at 12 weeks from timing of surgical intervention
Rate of Reoperation
The number of patients per arm requiring reoperation for any indication within 90 days of surgical intervention.
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
All-cause Mortality Rate
The number of patients deceased of any cause within 90 days of surgical intervention.
Time frame: From enrollment to end of treatment at 90 days from timing of surgical intervention
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