Knee OsteoarthritisPhase 4NCT07853885
Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee Arthroplasty
A Phase 4 study testing Tranexamic Acid and Normal Saline in people with Knee Osteoarthritis, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
Trial summary
This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Tranexamic Acid and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jul 2027
- Phase
- Phase 4
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 to 85 years.
- Diagnosis of primary knee osteoarthritis.
- Scheduled to undergo primary unilateral total knee arthroplasty.
- American Society of Anesthesiologists (ASA) physical status classification I to III.
- Willing to participate in the study and able to provide written informed consent.
Who cannot join
- Known allergy or hypersensitivity to tranexamic acid.
- History of thromboembolic disease, including deep vein thrombosis or pulmonary embolism.
- Known hypercoagulable state or current use of anticoagulant therapy, except for protocol-permitted perioperative anticoagulation
- Severe cardiac, hepatic, or renal dysfunction.
- History of vascular stent implantation or peripheral vascular disease.
- Active infection or previous surgery on the study knee.
- Abnormal coagulation function, including an international normalized ratio (INR) greater than 1.5.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Ning Lu, +86-13888574273, luningwei2@163.com
Ning Lu
About this study
Official title: Efficacy and Safety of Local Intraosseous Tranexamic Acid Injection for Reducing Perioperative Blood Loss in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial
This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.
Read the detailed description
Total knee arthroplasty may be associated with substantial perioperative blood loss. Tranexamic acid is commonly used to reduce bleeding during joint arthroplasty, but conventional systemic administration may result in greater systemic drug exposure. Local intraosseous administration may provide a higher drug concentration at the surgical site while limiting systemic exposure.
This study is a prospective, single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Seventy patients undergoing primary unilateral total knee arthroplasty for primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to an experimental group or a placebo control group.
Before skin incision, participants in the experimental group will receive tranexamic acid by local intraosseous injection into the cancellous bone of the tibial plateau and the medial and lateral condyles of the distal femur. Participants in the control group will undergo the same procedure using an equal volume of normal saline. Surgical technique, perioperative analgesia, rehabilitation, and other routine perioperative management will be standardized between the two groups.
The primary outcome is total perioperative blood loss, assessed using perioperative hematologic measurements through postoperative day 3. Secondary outcomes include postoperative hemoglobin reduction, transfusion rate and volume, postoperative pain, knee swelling, range of motion, functional recovery, length of hospital stay, and safety outcomes such as symptomatic deep vein thrombosis, pulmonary embolism, wound complications, infection, and other adverse events. Functional recovery will be assessed during follow-up through 3 months after surgery.
- Conditions
- Knee Osteoarthritis
- Being tested
- Tranexamic Acid, Normal Saline
- Keywords
- Total Knee Arthroplasty, Tranexamic Acid, Intraosseous Injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
A total dose of 2 g of tranexamic acid will be administered by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Of the total dose, 1 g will be injected into the cancellous bone of the tibial plateau, and 1 g will be injected into the medial and lateral condyles of the distal femur. The intervention will be administered using a standardized intraosseous injection technique.
Normal SalineDrug
Normal saline will be administered by the same local intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty. The volume, injection sites, timing, and administration procedure will be matched to those used in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Tranexamic Acid | Experimental | Participants assigned to this arm will receive a total dose of 2 g of tranexamic acid by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Tranexamic acid 1 g will be administered into the cancellous bone of the tibial plateau, and the remaining 1 g will be administered into the medial and lateral condyles of the distal femur. All other surgical, analgesic, and rehabilitation procedures will follow the standardized perioperative protocol. Receives: Drug: Tranexamic Acid |
| Normal Saline Placebo | Placebo comparator | Participants assigned to this arm will undergo the same intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty but will receive an equal volume of normal saline instead of tranexamic acid. All other surgical, analgesic, and rehabilitation procedures will be identical to those in the experimental arm. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Perioperative Blood Loss
Total perioperative blood loss will be calculated in milliliters (mL) using perioperative hematologic measurements and estimated blood volume based on preoperative and postoperative laboratory values.
Measured: From preoperative baseline through postoperative day 3
Secondary outcomes (12)
Maximum Decrease in Hemoglobin
Maximum decrease in hemoglobin from the preoperative value to the lowest postoperative value, expressed in g/L.
Measured: From preoperative baseline through postoperative day 3
Allogeneic Red Blood Cell Transfusion Rate
Proportion of participants who receive at least one allogeneic red blood cell transfusion from the start of surgery through hospital discharge.
Measured: From the start of surgery through hospital discharge,an anticipated average of 5-7 days.
Volume of Allogeneic Red Blood Cell Transfusion
Total volume of allogeneic red blood cells transfused from the start of surgery through hospital discharge.
Measured: From the start of surgery through hospital discharge，an anticipated average of 5-7 days.
Pain Intensity at Rest
Postoperative pain at rest will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Postoperative day 1, postoperative day 3
Pain Intensity During Activity
Postoperative pain during activity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Postoperative day 1, postoperative day 3
Knee Swelling
Knee circumference measured 10 cm above the superior border of the patella.
Measured: Preoperative baseline, postoperative day 1, and postoperative day 3
Knee Range of Motion
Knee range of motion measured in degrees.
Measured: Preoperative baseline, postoperative day 1, and postoperative day 3
Knee Functional Score
Knee function will be assessed using the Hospital for Special Surgery (HSS) Knee Score. The total score ranges from 0 to 100, with higher scores indicating better knee function.
Measured: Within 24 hours before hospital discharge, 4 weeks after surgery, and 3 months after surgery
Length of Hospital Stay
Duration of postoperative hospitalization, expressed in days.
Measured: From the day of surgery through hospital discharge, an anticipated average of 5-7 days.
Symptomatic Deep Vein Thrombosis
Incidence of symptomatic deep vein thrombosis confirmed by vascular ultrasonography.
Measured: Up to 30 days after surgery
Symptomatic Pulmonary Embolism
Incidence of symptomatic pulmonary embolism confirmed by computed tomography pulmonary angiography when clinically indicated.
Measured: Up to 30 days after surgery
Other Postoperative Complications
Incidence of postoperative complications, including wound infection, wound drainage or poor healing, neurovascular injury, systemic allergic reaction, and abnormal liver or kidney function.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intraosseous tranexamic acid group or the placebo control group and will remain in the assigned group throughout the study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ning Lu, The Second Affiliated Hospital of Kunming Medical University
- Investigators
- Ning Lu, Principal investigator, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853885
- Sponsor's protocol ID
- SL-KY-2026-96
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Local Intraosseous Tranexamic Acid Injection for Reducing Perioperative Blood Loss in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07853885
- Acronym / sponsor ID
- SL-KY-2026-96
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Tranexamic Acid, Intraosseous Injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.
Detailed description
Total knee arthroplasty may be associated with substantial perioperative blood loss. Tranexamic acid is commonly used to reduce bleeding during joint arthroplasty, but conventional systemic administration may result in greater systemic drug exposure. Local intraosseous administration may provide a higher drug concentration at the surgical site while limiting systemic exposure.
This study is a prospective, single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Seventy patients undergoing primary unilateral total knee arthroplasty for primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to an experimental group or a placebo control group.
Before skin incision, participants in the experimental group will receive tranexamic acid by local intraosseous injection into the cancellous bone of the tibial plateau and the medial and lateral condyles of the distal femur. Participants in the control group will undergo the same procedure using an equal volume of normal saline. Surgical technique, perioperative analgesia, rehabilitation, and other routine perioperative management will be standardized between the two groups.
The primary outcome is total perioperative blood loss, assessed using perioperative hematologic measurements through postoperative day 3. Secondary outcomes include postoperative hemoglobin reduction, transfusion rate and volume, postoperative pain, knee swelling, range of motion, functional recovery, length of hospital stay, and safety outcomes such as symptomatic deep vein thrombosis, pulmonary embolism, wound complications, infection, and other adverse events. Functional recovery will be assessed during follow-up through 3 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intraosseous tranexamic acid group or the placebo control group and will remain in the assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Tranexamic Acid | Experimental | Drug: Tranexamic AcidParticipants assigned to this arm will receive a total dose of 2 g of tranexamic acid by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Tranexamic acid 1 g will be administered into the cancellous bone of the tibial plateau, and the remaining 1 g will be administered into the medial and lateral condyles of the distal femur. All other surgical, analgesic, and rehabilitation procedures will follow the standardized perioperative protocol. |
| Normal Saline Placebo | Placebo comparator | Drug: Normal SalineParticipants assigned to this arm will undergo the same intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty but will receive an equal volume of normal saline instead of tranexamic acid. All other surgical, analgesic, and rehabilitation procedures will be identical to those in the experimental arm. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50 to 85 years.
- Diagnosis of primary knee osteoarthritis.
- Scheduled to undergo primary unilateral total knee arthroplasty.
- American Society of Anesthesiologists (ASA) physical status classification I to III.
- Willing to participate in the study and able to provide written informed consent.
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to tranexamic acid.
- History of thromboembolic disease, including deep vein thrombosis or pulmonary embolism.
- Known hypercoagulable state or current use of anticoagulant therapy, except for protocol-permitted perioperative anticoagulation
- Severe cardiac, hepatic, or renal dysfunction.
- History of vascular stent implantation or peripheral vascular disease.
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 AcidA total dose of 2 g of tranexamic acid will be administered by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Of the total dose, 1 g will be injected into the cancellous bone of the tibial plateau, and 1 g will be injected into the medial and lateral condyles of the distal femur. The intervention will be administered using a standardized intraosseous injection technique. | Drug | Intraosseous Tranexamic Acid |
| Normal SalineNormal saline will be administered by the same local intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty. The volume, injection sites, timing, and administration procedure will be matched to those used in the experimental group. | Drug | Normal Saline Placebo |
Primary outcome
Total Perioperative Blood Loss
Time frame: From preoperative baseline through postoperative day 3
Total perioperative blood loss will be calculated in milliliters (mL) using perioperative hematologic measurements and estimated blood volume based on preoperative and postoperative laboratory values.
12 secondary outcomes
Maximum Decrease in Hemoglobin
Time frame: From preoperative baseline through postoperative day 3
Allogeneic Red Blood Cell Transfusion Rate
Time frame: From the start of surgery through hospital discharge,an anticipated average of 5-7 days.
Volume of Allogeneic Red Blood Cell Transfusion
Time frame: From the start of surgery through hospital discharge，an anticipated average of 5-7 days.
Pain Intensity at Rest
Time frame: Postoperative day 1, postoperative day 3
Pain Intensity During Activity
Time frame: Postoperative day 1, postoperative day 3
Knee Swelling
Time frame: Preoperative baseline, postoperative day 1, and postoperative day 3
Knee Range of Motion
Time frame: Preoperative baseline, postoperative day 1, and postoperative day 3
Knee Functional Score
Time frame: Within 24 hours before hospital discharge, 4 weeks after surgery, and 3 months after surgery
Length of Hospital Stay
Time frame: From the day of surgery through hospital discharge, an anticipated average of 5-7 days.
Symptomatic Deep Vein Thrombosis
Time frame: Up to 30 days after surgery
Symptomatic Pulmonary Embolism
Time frame: Up to 30 days after surgery
Other Postoperative Complications
Time frame: Up to 30 days after surgery
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ning Lu principal investigator
The Second Affiliated Hospital of Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid and Normal Saline in people with Knee Osteoarthritis, run by The Second Affiliated Hospital of Kunming Medical University at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 9 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact NIng Lu (+86-13888574273, luningwei2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Perioperative Blood Loss (time frame: From preoperative baseline through postoperative day 3). 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 9 Oct 2026.