Osteo Arthritis KneePhase 3NCT06618820
Extended Oral Tranexamic Acid After Total Knee Arthroplasty
A Phase 3 study testing Tranexamic acid in people with Osteo Arthritis Knee and Pain, Postoperative, run by Campbell Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Pain, Postoperative
- What is being tested?
- Tranexamic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2024to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older.
- Primary TKA at a Campbell Clinic Surgery Center, with implant at the discretion of the treating surgeon.
- Willing to participate in the study.
- Fluent in oral and written English.
Who cannot join
- Revision TKA.
- Preoperative use of anticoagulants (81mg aspirin is allowed).
- Prior history of deep vein thrombosis.
- Prior history of cancer (with the exception of non-melanoma/metastatic skin cancers, low-grade non-metastatic benign soft tissue tumors, thyroid cancers and low grade, non-metastatic prostate cancers).
- Known allergy or hypersensitivity to TXA.
- Patients who are using combination hormonal contraception.
- History of seizure disorder.
- History of adult onset colorblindness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Control Trial for Oral Extended Tranexamic Acid After Total Knee Arthroplasty
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.
Read the detailed description
Total Knee Arthroplasty (TKA) is the treatment for end-stage osteoarthritis. Osteoarthritis stands as one of the prevailing chronic health issues globally. Specifically, knee osteoarthritis represents the predominant form of osteoarthritis in more than half of those diagnosed with the condition. With the aging population, there's a projected exponential rise in the annual TKA procedures performed. The ultimate goals of TKA are to improve mobility and quality of life. However, the benefits of TKA come with risks of surgery. According to the American Joint Replacement Registry, 1% of patients experienced at least one complication within 90 days after their surgery. Many efforts have been made to reduce the rate of complications following TKA. Reducing perioperative blood loss and thus reducing the need for postoperative blood transfusion is critical to ensure positive outcomes for TKA patients. Traditionally, preoperative iron therapy, erythropoietin, and autologous blood donation are mitigation strategies used to decrease the need for blood transfusion. In recent years, the intraoperative use of antifibrinolytic medication, such as Tranexamic Acid (TXA), to control blood loss and improve clinical outcomes has gained increased attention.
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 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.
- Conditions
- Osteo Arthritis Knee, Pain, Postoperative
- Being tested
- Tranexamic acid, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called TXA
One dose consists of three 650 milligram (mg) capsules, to be taken orally.
PlaceboDrug
Also called microcrystalline cellulose
One dose consists of three microcrystalline cellulose capsules.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive 10 doses of microcrystalline cellulose (3 capsules per dose) from postoperative day (POD) 1 to POD 10. Receives: Drug: Placebo |
| 3-day tranexamic acid (TXA) | Experimental | Patients will receive three 1950 milligram (mg) doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 3 and 7 doses of Placebo from POD 4 to POD 10. Receives: Drug: Tranexamic acid; Drug: Placebo |
| 10-day TXA | Experimental | Patients will receive ten 1950mg doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 10. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score - Knee
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.
Measured: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Range of Motion
Passive flexion and extension range of motion of the surgical knee will be assessed with a goniometer in degrees.
Measured: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Secondary outcomes (6)
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
This questionnaire assesses patients' knee health with 0 representing total disability and 100 represents perfect knee health.
Measured: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Patient-Reported Outcomes Measurement Information System
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.
Measured: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Visual Analog Scale
This questionnaire assesses patient's pain level with 0 being no pain at all and 10 being worst pain possible.
Measured: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Opiate pill count
The investigators will record the number of opiate medication taken by the patient and calculate morphine milligram equivalents.
Measured: postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Ambulatory aid
The investigators will record the use of ambulatory aid, such as walker.
Measured: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Adverse Event
The investigators will monitor for adverse events, including but not limited to deep venous thrombosis, and pulmonary embolism.
Measured: From signing consent form to completion of 1 year follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start17 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Holland, MD, Campbell Clinic
- Investigators
- Christopher Holland, MD, MS, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618820
- Sponsor's protocol ID
- 24-10171-FB
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial for Oral Extended Tranexamic Acid After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06618820
- Acronym / sponsor ID
- 24-10171-FB
- Conditions
- Osteo Arthritis Knee, Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Total Knee Arthroplasty (TKA) is the treatment for end-stage osteoarthritis. Osteoarthritis stands as one of the prevailing chronic health issues globally. Specifically, knee osteoarthritis represents the predominant form of osteoarthritis in more than half of those diagnosed with the condition. With the aging population, there's a projected exponential rise in the annual TKA procedures performed. The ultimate goals of TKA are to improve mobility and quality of life. However, the benefits of TKA come with risks of surgery. According to the American Joint Replacement Registry, 1% of patients experienced at least one complication within 90 days after their surgery. Many efforts have been made to reduce the rate of complications following TKA. Reducing perioperative blood loss and thus reducing the need for postoperative blood transfusion is critical to ensure positive outcomes for TKA patients. Traditionally, preoperative iron therapy, erythropoietin, and autologous blood donation are mitigation strategies used to decrease the need for blood transfusion. In recent years, the intraoperative use of antifibrinolytic medication, such as Tranexamic Acid (TXA), to control blood loss and improve clinical outcomes has gained increased attention.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive 10 doses of microcrystalline cellulose (3 capsules per dose) from postoperative day (POD) 1 to POD 10. |
| 3-day tranexamic acid (TXA) | Experimental | Drug: Tranexamic acid, Drug: PlaceboPatients will receive three 1950 milligram (mg) doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 3 and 7 doses of Placebo from POD 4 to POD 10. |
| 10-day TXA | Experimental | Drug: Tranexamic acidPatients will receive ten 1950mg doses of Oral TXA (three 650mg capsules per dose) from POD 1 to POD 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age and older.
- Primary TKA at a Campbell Clinic Surgery Center, with implant at the discretion of the treating surgeon.
- Willing to participate in the study.
- Fluent in oral and written English.
Key exclusion criteria (8 listed)
- Revision TKA.
- Preoperative use of anticoagulants (81mg aspirin is allowed).
- Prior history of deep vein thrombosis.
- Prior history of cancer (with the exception of non-melanoma/metastatic skin cancers, low-grade non-metastatic benign soft tissue tumors, thyroid cancers and low grade, non-metastatic prostate cancers).
- Known allergy or hypersensitivity to TXA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: TXAOne dose consists of three 650 milligram (mg) capsules, to be taken orally. | Drug | 10-day TXA, 3-day tranexamic acid (TXA) |
| PlaceboAlso: microcrystalline celluloseOne dose consists of three microcrystalline cellulose capsules. | Drug | 3-day tranexamic acid (TXA), Placebo |
Primary outcome
Forgotten Joint Score - Knee
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.
Range of Motion
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.
6 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Patient-Reported Outcomes Measurement Information System
Time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Visual Analog Scale
Time frame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Opiate pill count
Time frame: postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Ambulatory aid
Time frame: Enrollment; postoperative day 1 to postoperative day 14; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.
Adverse Event
Time frame: From signing consent form to completion of 1 year follow up visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Holland, MD, MS principal investigator
Campbell Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid in people with Osteo Arthritis Knee and Pain, Postoperative, run by Campbell Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forgotten Joint Score - Knee (time frame: Enrollment; 2-week postoperative; 6-week postoperative; 12-week postoperative; 1-year postoperative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.