Osteoarthritis (OA) of the Hip, Osteoarthritis (OA) of the Knee
Conditions
Keywords
Tranexamic acid, Patient Reported Outcomes, Arthroplasty
Brief summary
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.
Interventions
DRUGExtended oral tranexamic acid regimen
Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.
DRUGPlacebo
Patients will receive an oral placebo medication on post-operative day 1, 2, and 3.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis * Ability to provide written informed consent * Willingness to comply with study protocol
Exclusion criteria
* History of venous thromboembolism (DVT or PE) * Active malignancy * Allergy or contraindication to tranexamic acid (TXA) * Post-operative anticoagulation therapy other than aspirin * History of color blindness or retinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At 6 weeks from timing of surgical intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At 2 weeks from timing of surgical intervention | 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. |
| 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 | At 12 weeks from timing of surgical intervention | 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. |
| 2-week Visual Analog Scale (VAS) pain score | At 2 weeks from timing of surgical intervention | Visual analog scale (VAS) pain score at 2 weeks post-operatively. Scale is 0-10 with higher scores representing more pain. |
| 6-week Visual Analog Scale (VAS) pain score | At 6 weeks from timing of surgical intervention | Visual analog scale (VAS) pain score at 6 weeks post-operatively. Scale is 0-10 with higher scores representing more pain. |
| 12-week Visual Analog Scale (VAS) pain score | At 12 weeks from timing of surgical intervention | Visual analog scale (VAS) pain score at 12 weeks post-operatively. Scale is 0-10 with higher scores representing more pain. |
| 6-week absolute knee flexion | At 6 weeks from timing of surgical intervention | Degrees of knee flexion achieved at the 6 week post-operative mark for patients undergoing Total Knee Arthroplasty |
| Transfusion rate | From enrollment to end of treatment at 12 weeks from timing of surgical intervention | Percentage of patients per arm requiring post-operative transfusion of blood products |
| Blood product units transfused | From enrollment to end of treatment at 12 weeks from timing of surgical intervention | For each arm, the average number of blood product units transfused per patient |
| Incidence of Symptomatic DVT | From enrollment to end of treatment at 90 days from timing of surgical intervention | The number of post-operative symptomatic deep vein thromboses identified in each arm |
| Incidence of Symptomatic PE | From enrollment to end of treatment at 90 days from timing of surgical intervention | The number of post-operative symptomatic pulmonary embolisms identified in each arm |
| Incidence of Acute Coronary Sndrome | From enrollment to end of treatment at 90 days from timing of surgical intervention | 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. |
| Incidence of Cerebrovascular Accident | From enrollment to end of treatment at 90 days from timing of surgical intervention | The number of post-operative cerebrovascular accidents (CVAs), defined as ischemic or hemorrhagic stroke. |
| Rate of Readmission | From enrollment to end of treatment at 12 weeks from timing of surgical intervention | The number of patients per arm requiring readmission for any reason within 90 days of surgical intervention. |
| Rate of Reoperation | From enrollment to end of treatment at 90 days from timing of surgical intervention | The number of patients per arm requiring reoperation for any indication within 90 days of surgical intervention. |
| All-cause Mortality Rate | From enrollment to end of treatment at 90 days from timing of surgical intervention | The number of patients deceased of any cause within 90 days of surgical intervention. |
Contacts
CONTACTRyland Kagan, MD
CONTACTMadison Hayes-Lattin, MD
Outcome results
None listed