Postoperative PainPhase 2NCT06479161
Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty
A Phase 2 study testing Tranexamic acid in people with Postoperative Pain, run by Matthew Grosso, MD at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- 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
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 19 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
- Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).
- Male and female patient age 18-89
- Primary diagnosis of knee osteoarthritis
Who cannot join
- Revision TKA
- No exclusion based on gender
- Patients <18 and >89 years old
- TXA allergy - there are NO absolute contraindications for TXA use.
- History of stent placed within one year of surgery - patient will receive topical TXA as an alternative.
- o Actively treated cancer or deep vein thrombosis (DVT)
Show all 19Show fewer
- Chronic opioid use (opioid use within the 4 weeks prior to surgery)
- Allergies to nonsteroidal Anti-inflammatory drugs (NSAIDs) and acetaminophen
- Patients with clinically significant drug interactions
- Pre-existing neuropathy
- Current or previous venous thrombosis (DVT or venous stasis disease)
- Immuno-compromised secondary to medical condition
- Immune-suppressive medications, chemotherapy
- Pregnancy, breast feeding
- History of pain catastrophizing. Major depressive disorder
- History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Currently on a neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.].
- Non-English speaking and reading patient populations
- Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course.
Trial locations and contacts
1 site in 1 country.
United States1 site
Trinity Health Of New England/CT Joint Replacement Institute
Hartford, Connecticut, 06105
About this study
Official title: Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial
The primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.
Read the detailed description
Randomized controlled trial with 1:1 allocation, selected through computer-based randomization.
This study will review prospectively collected data, including patient demographic information, surgeon, use of oral tranexamic acid (TXA) or placebo regimen, and postoperative outcomes up to 3 months after surgery. Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication.
This will be a double blinded study, with both patient and surgeon blinded to study group.
6.0 TXA dosing protocol TXA day of surgery [All patients]
- Administer 1-gram IV TXA intraoperatively at the start of the case (hold for history of stent within 1 year of surgery)
- AND
- Administer 1-gram IV TXA postoperatively before leaving PACU (hold for history of stent within 1 year of surgery)
- OR
- Exception: Administer 2 grams TXA in 50cc normal saline topically during the case for patients with a history of stent placed within one year of surgery.
TXA postoperative day (POD) 1-3 [Experimental group]
- Administer 1.95 grams oral (3- 650 mg tablets) TXA each morning for three days following surgery.
- Patients discharged home before POD 3 will be sent home with remaining oral TXA doses.
Placebo POD 1-3 [Control group]
- Administer oral placebo (3 tablets) each morning for three days following surgery.
- Patients discharged home before POD 3 will be sent home with remaining oral placebo doses.
- Conditions
- Postoperative Pain
- Being tested
- Tranexamic acid
- 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
1.95 grams oral
| Study group | Role | What they receive |
|---|---|---|
| TXA | Active comparator | - 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use. Receives: Drug: Tranexamic acid |
| Placebo | Placebo comparator | - 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) Pain scores
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.
Measured: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).
Secondary outcomes (3)
Range of Motion
Clinical measurement of passive, pain-free range of motion of knee in degrees from 0 to 180 from maximum extension to maximum flexion
Measured: at 2, 6 and 12 week follow up visits
Opioid consumption
Subjects will keep a log recording opioid consumption. Research staff will ask subjects to report opioids during postoperative telephone calls.
Measured: POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days)
Ambulation Status
Surgeon or physical therapist will record if patient is using a walker, cane or no assistive devices.
Measured: at 2, 6 and 12 week follow up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start10 Jun 2024
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Grosso, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Grosso, MD, Trinity Health Of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479161
- Sponsor's protocol ID
- SFH 24-05
- Status last verified
- Dec 2024
- First submitted
- 20 Jun 2024
- Last updated
- 29 Oct 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Tranexamic Acid Following Total Knee Arthroplasty on Postoperative Pain and Range of Motion: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06479161
- Acronym / sponsor ID
- SFH 24-05
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Matthew Grosso, MDUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 28 Jun 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 primary purpose of this study is to evaluate postoperative pain. Secondary outcomes evaluated in this study will include range of motion (ROM), opioid consumption, and ambulation. Each outcome measure will be evaluated, oral tranexamic acid (TXA) in the experiment arm and placebo in the control arm, after total knee arthroplasty (TKA) at postoperative days 0-3, and weeks 1, 2, 6, and 12.
Detailed description
Randomized controlled trial with 1:1 allocation, selected through computer-based randomization.
This study will review prospectively collected data, including patient demographic information, surgeon, use of oral tranexamic acid (TXA) or placebo regimen, and postoperative outcomes up to 3 months after surgery. Collaboration with Saint Francis' pharmacy team will be performed to ensure appropriate blinded administering of the oral TXA and placebo medication.
This will be a double blinded study, with both patient and surgeon blinded to study group.
6.0 TXA dosing protocol TXA day of surgery [All patients]
- Administer 1-gram IV TXA intraoperatively at the start of the case (hold for history of stent within 1 year of surgery)
- AND
- Administer 1-gram IV TXA postoperatively before leaving PACU (hold for history of stent within 1 year of surgery)
- OR
- Exception: Administer 2 grams TXA in 50cc normal saline topically during the case for patients with a history of stent placed within one year of surgery.
TXA postoperative day (POD) 1-3 [Experimental group]
- Administer 1.95 grams oral (3- 650 mg tablets) TXA each morning for three days following surgery.
- Patients discharged home before POD 3 will be sent home with remaining oral TXA doses.
Placebo POD 1-3 [Control group]
- Administer oral placebo (3 tablets) each morning for three days following surgery.
- Patients discharged home before POD 3 will be sent home with remaining oral placebo doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | Active comparator | Drug: Tranexamic acid- 1.95 grams oral TXA (tranexamic acid) (3- 650 mg tablets) administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use. |
| Placebo | Placebo comparator | Drug: Tranexamic acid- 3 tablets administered postop day one, postop day two and postop day three. Compounded by registered pharmacist and labeled with subject name and instructions for use. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - All patients undergoing either manual or robotic primary total knee arthroplasty (TKA)
- Performed by participating Connecticut Joint Replacement Institute (CJRI) surgeons (Dr. Matthew Grosso, Dr. Robert McAllister, Dr. Chad Daniel, Dr. Eric Silverstein, Dr. Alex Dukas, Dr. Michael Joyce, Dr. Brett Wasserlauf).
- Male and female patient age 18-89
- Primary diagnosis of knee osteoarthritis
Key exclusion criteria (19 listed)
- Revision TKA
- No exclusion based on gender
- Patients <18 and >89 years old
- o Actively treated cancer or deep vein thrombosis (DVT)
- Chronic opioid use (opioid use within the 4 weeks prior to surgery)
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 acid1.95 grams oral | Drug | Placebo, TXA |
Primary outcome
Visual Analogue Scale (VAS) Pain scores
Time frame: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).
Patient reported pain score from 0 to 10 where 0 is no pain and 10 is the most pain. Higher scores are a worse outcome.
3 secondary outcomes
Range of Motion
Time frame: at 2, 6 and 12 week follow up visits
Opioid consumption
Time frame: POD 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days)
Ambulation Status
Time frame: at 2, 6 and 12 week follow up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic acid in people with Postoperative Pain, run by Matthew Grosso, MD 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 19 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: finished, as of the sponsor's last update on 29 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analogue Scale (VAS) Pain scores (time frame: postoperative day (POD) 0, 1, 2, 3 (+/- 0 days) and weeks 1 (+/- 0 days), 2 (+/- 2 days), 6 and 12 (+/- 7 days).). 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 29 Oct 2026.