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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Oral TXA | Experimental | Participants will receive standard 1.95mg pre-operative oral TXA dose in addition to 1.95mg oral TXA on post-operative days 1, 2, and 3. |
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| Placebo | Placebo Comparator | Patients will receive standard pre-operative 1.95mg oral TXA, followed by a placebo pill on post-operative days 1, 2 and 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended oral tranexamic acid regimen | Drug | Participants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 weeks from timing of surgical intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryland Kagan, MD | Contact | 503 494-6400 | kagan@ohsu.edu | |
| Madison Hayes-Lattin, MD | Contact | 503) 494-6400 | hayeslam@ohsu.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo | Drug | Patients will receive an oral placebo medication on post-operative day 1, 2, and 3. |
|
| 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. | 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. | 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. | 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. | 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 | At 6 weeks from timing of surgical intervention |
| Transfusion rate | Percentage of patients per arm requiring post-operative transfusion of blood products | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | From enrollment to end of treatment at 90 days from timing of surgical intervention |