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The purpose of this study is to evaluate the impact of an extended oral Tranexamic Acid regimen on patient reported outcome scores, time to independent ambulation, postoperative range of motion, swelling, change in hemoglobin levels, 90-day complications, readmission and reoperation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral tranexamic acid | Experimental |
| |
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Tranexamic Acid | Drug | Subjects will receive a 1.95 g dose of oral TXA at the following timepoints: (1) following ambulation, (2) postoperative day 1, (3) postoperative day 2, and (4) postoperative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score | The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. | Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks |
| Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) | The Hip Disability and Osteoarthritis Outcome Score (HOOS) for Joint Replacement (JR) is a questionnaire designed to measure outcomes for patients with hip replacements. Results are scored 0-11. 0 = total hip disability, 100 = perfect hip health. | Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin | Baseline, prior to discharge, day 3 postoperatively |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Bingham | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Harris Hip Score (HHS) | The Harris Hip Score (HHS) is a tool used to assess hip function and the results of hip treatments, such as hip replacements. It's a 100-point scale that measures four areas: pain, function, deformity, and range of motion. A higher score indicates less dysfunction and better outcomes. A score of less than 70 is considered poor, 70-80 is fair, 80-90 is good, and 90-100 is excellent. | Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks |
| Short Form Health Survey (SF-12) | The 12-Item Short Form Health Survey (SF-12) is a questionnaire which consists of 12 questions covering physical and mental health domains. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. | Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks |
| Time to Independent Ambulation | Duration of time post-operation until the subject can walk without any support or assistance, reported in days | 12 weeks |
| Oxford Hip Score | The Oxford Hip Score (OHS) is a standard patient-reported outcome (PRO) measure, or PROM, developed to assess function and pain in patients undergoing total hip replacement (THR) surgery, particularly in the context of clinical trials. The OHS has also been used for the assessment of patient outcomes, including physical therapy, and use of joint supplements (disease specific and general health measure are two other outcome measures). | Baseline, 3 days postoperative, 2 weeks, 6 weeks, 12 weeks |