Campbell Clinic
Germantown, Tennessee, 38138, United States
NCT Number: NCT06618820
The utilization of intraoperative tranexamic acid (TXA), whether administered intravenously or orally, has become a standard practice in total joint arthroplasty (TJA). Multiple studies have demonstrated the positive impact that TXA application has on clinical outcomes, including decreased blood loss and transfusion rates, decreased early swelling and ecchymosis, improved early recovery, and potentially superior long-term outcomes. Its ability to mitigate risk of blood loss made ambulatory total knee arthroplasty (TKA) safer for patients. The safety of intraoperative TXA use has also been documented. Sabbag et al. showed that TXA does not increase the risk of venous thromboembolism (VTE), even in those patients who are deemed high-risk. Multiple routes of TXA administration have been studied with each route demonstrating effectiveness in reducing blood loss. Findings showed that oral TXA is noninferior to intravenous TXA, though the median time to reach a target concentration is longer via the oral route and bioavailability is lower. With the benefits of intraoperative TXA clearly documented in literature, multiple centers investigated the utilization of extended TXA postoperatively in hopes of enhancing patient safety and reducing length of stay and healthcare cost. However, these studies reported conflicting outcomes and mostly focused on estimated blood loss, instead of patient reported outcomes.
The purpose of this study is to assess the effectiveness and safety of a varying extended oral TXA regimen during the postoperative period. Further, the investigators aim to determine the optimal duration of the TXA regimen to maximize its impact. The investigators hypothesize that an extended oral TXA regimen is safe and effective in improving clinical outcomes in TKA patients.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Germantown, Tennessee, 38138, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One dose consists of three 650 milligram (mg) capsules, to be taken orally.
One dose consists of three microcrystalline cellulose capsules.
Other names: microcrystalline cellulose
Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
The Forgotten Joint Score measures how much the patient is aware of their affected knee during activities of daily living. A score of 0 indicates that the patient is always aware of their affected knee whereas a score of 100 indicates that the patient is not aware of their affected knee during activities of daily living.
Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Passive flexion and extension range of motion of the surgical knee will be assessed with a goniometer in degrees.
Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
This questionnaire assesses patients' knee health with 0 representing total disability and 100 represents perfect knee health.
Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
This questionnaire assesses patients' overall health and wellbeing with a T-score of 16.2 representing most severe physical impairment and a T-score of 67.7 represents best possible state of health.
Time frame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
This questionnaire assesses patient's pain level with 0 being no pain at all and 10 being worst pain possible.
Time frame: postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
The investigators will record the number of opiate medication taken by the patient and calculate morphine milligram equivalents.
Time frame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
The investigators will record the use of ambulatory aid, such as walker.
Time frame: From signing consent form to completion of 1 year follow up visit.
The investigators will monitor for adverse events, including but not limited to deep venous thrombosis, and pulmonary embolism.
Campbell Clinic
Other
Randomized Control Trial for Oral Extended Tranexamic Acid After Total Knee Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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