Monocompartimental Tibiofemoral OsteoarthritisNCT04785651

Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

A study testing Tibial osteotomy with Tranexamic acid and Tibial osteotomy without Tranexamic acid in people with Monocompartimental Tibiofemoral Osteoarthritis and Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Monocompartimental Tibiofemoral Osteoarthritis, Osteoarthritis
What is being tested?: Tibial osteotomy with Tranexamic acid and Tibial osteotomy without Tranexamic acid
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 1 siteItaly
Study dates: 22 Feb 2021to 9 May 2025
Phase: Interventional
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients aged between 18 and 70 years;
Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation > 5°;
Surgical indication for corrective osteotomy;
Isolated osteotomy surgical procedure.

Who cannot join

Contraindication criteria for the administration of tranexamic acid, as assessed by the Anaesthesia and Resuscitation specialist during the pre-operative visit. The following will be considered absolute contraindications: epilepsy, thrombophilia and known allergy to the active substance, severe renal insufficiency and acute venous or arterial thrombosis, while the following will be considered relative contraindications: coronary stents in patients who have discontinued treatment with antiplatelet agents and previous deep vein thrombosis;
Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism);
BMI > 40;
Incapacitated patients;
Patients abusing alcoholic beverages, drugs or medication.
Patients who are pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Istituto Ortopedico Rizzoli
Bologna, 40136

Other trials in Italy

About this study

Official title: Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.

A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies.

All the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery

Read the detailed description

Tibial osteotomies represents a well-established treatment option for the medial femorotibial knee arthrosis.

Osteotomy can be performed in minus or in plus, at the latter case with or without interposition of tissue (autologous bone, heterologous bone or bone substitute).

Even though excessive bleeding is not a frequent complication, the blood loss and formation of subcutaneous haematoma can determinate more post-interventional pain, wound suffering and the risk of infections.

Tranexamic acid is an antifibrinolytic agent and its use in proximal tibia osteotomies has been retrospectively evaluated in a number of papers, all of which agree on its safety and efficacy in terms of reducing peri-operative bleeding. However, to date there have been no randomised clinical trials demonstrating its superiority in terms of reducing bleeding, subcutaneous haematoma and wound complications in proximal tibia osteotomies.

This is a randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding , pain and wound complications reduction in tibial osteotomies

Conditions: Monocompartimental Tibiofemoral Osteoarthritis, Osteoarthritis
Being tested: Tibial osteotomy with Tranexamic acid, Tibial osteotomy without Tranexamic acid
Keywords: tibial osteotomy, tranexamic acid
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tibial osteotomy with Tranexamic acidDrug
Patients who will be in the treatment arm after randomisation will receive 100ml saline with a dosage of 20 mg/kg tranexamic acid intravenously at induction. An additional administration of tranexamic acid (10 mg/kg in 100ml intravenous saline) will be given as a booster at the end of the surgical procedure.
All the patients will undergo to the same tibial osteotomy procedure.
Tibial osteotomy without Tranexamic acidProcedure or surgery
Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice

Study groups in NCT04785651
Study group	Role	What they receive
Tranexamic arm	Experimental	Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid. Receives: Drug: Tibial osteotomy with Tranexamic acid
control arm	Other	Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid Receives: Procedure: Tibial osteotomy without Tranexamic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Perioperative blood loss (haemoglobin balance):
The perioperative blood loss will be estimated by assessing the haemoglobin balance on the first postoperative day
Measured: Basal vs the first post operative day

Secondary outcomes (6)

Postoperative transfusion rate
the percentage of transfusions carried out in the two treatment groups will be determined;
Measured: Perioperative time and postoperative time ( up to 60 days)
Postoperative blood loss
The perioperative blood loss will be estimated by assessing the blood loss after surgery (through the volume of blood collected by drainage);
Measured: Postoperatively (up to 2 days)
Blood loss after discharge
Post-discharge blood loss will be estimated by assessing haemoglobin balance at 5 and 15 days post-surgery;
Measured: at 5 and 15 days post hospital discharge
International Knee Documentation Committee objective
The objective rating scale has seven parameters related to knee function. The presence of effusions and degree of knee movement are assessed, the worst value of one of these parameters determines the final IKDC grade. There are four grades (A, B, C, D) that identify a knee assessed as normal, near normal, abnormal and severely abnormal, respectively.
Measured: Baseline, 30 and 60 days post treatment
Visual Analogue Scale - Pain
visual analogue scale consisting of a straight line segment (10 cm long), the ends of which correspond to 'no pain' and 'strongest pain imaginable'.
Measured: baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);
Soft tissue status
The condition of the soft tissues (swelling, surgical haematoma, wound distress) will be documented and analysed between the two groups by means of photographic documentation and through the Hollander Wound Evaluation Scales
Measured: perioperatively, 30 and 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 20219 May 2025

First posted8 Mar 2021
Study start22 Feb 2021
Primary completion9 May 2025
Study completion9 May 2025

Why it stopped: Patient enrollment was proceeding slower than planned

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Monocompartimental Tibiofemoral OsteoarthritisStudies of the same condition, open and under way.
More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04785651
Sponsor's protocol ID: TXA-HTO
Status last verified: Jul 2025
First submitted: 16 Feb 2021
Last updated: 22 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.
PubMed 25440395
Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.
PubMed 21512813
Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
PubMed 29939895

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.
ClinicalTrials.gov ID: NCT04785651
Acronym / sponsor ID: TXA-HTO
Conditions: Monocompartimental Tibiofemoral Osteoarthritis, Osteoarthritis
Keywords: tibial osteotomy, tranexamic acid
Study type: Interventional
Recruitment status: TerminatedReason stopped: Patient enrollment was proceeding slower than planned
Enrolment: 49 participants (actual)
Lead sponsor: Istituto Ortopedico RizzoliUniversity, hospital or other
Study start: 22 Feb 2021 (actual)
Primary completion: 9 May 2025 (actual)
Study completion: 9 May 2025 (actual)
First posted: 8 Mar 2021 (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.

A randomised controlled double-blind clinical trial focused on the evaluation of the effectiveness of the tranexamic acid on bleeding, pain and wound complications reduction in tibial osteotomies.

All the 84 included patients will be randomized in one of the two arms, will undergo to a tibial osteotomy and then will prospectively evaluate at different follow ups until 60 days post-surgery

Detailed description

Tibial osteotomies represents a well-established treatment option for the medial femorotibial knee arthrosis.

Osteotomy can be performed in minus or in plus, at the latter case with or without interposition of tissue (autologous bone, heterologous bone or bone substitute).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tranexamic arm	Experimental	Drug: Tibial osteotomy with Tranexamic acidPatients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.
control arm	Other	Procedure: Tibial osteotomy without Tranexamic acidPatients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female patients aged between 18 and 70 years;
Single-part tibiofemoral osteoarthritis (K-L 1-3), axial deviation > 5°;
Surgical indication for corrective osteotomy;
Isolated osteotomy surgical procedure.

Key exclusion criteria (6 listed)

Contraindication criteria for the administration of tranexamic acid, as assessed by the Anaesthesia and Resuscitation specialist during the pre-operative visit. The following will be considered absolute contraindications: epilepsy, thrombophilia and known allergy to the active substance, severe renal insufficiency and acute venous or arterial thrombosis, while the following will be considered relative contraindications: coronary stents in patients who have discontinued treatment with antiplatelet agents and previous deep vein thrombosis;
Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism);
BMI > 40;
Incapacitated patients;
Patients abusing alcoholic beverages, drugs or medication.

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
Tibial osteotomy with Tranexamic acidPatients who will be in the treatment arm after randomisation will receive 100ml saline with a dosage of 20 mg/kg tranexamic acid intravenously at induction. An additional administration of tranexamic acid (10 mg/kg in 100ml intravenous saline) will be given as a booster at the end of the surgical procedure. All the patients will undergo to the same tibial osteotomy procedure.	Drug	Tranexamic arm
Tibial osteotomy without Tranexamic acidPatients in this arm will undergo to the tibial osteotomy procedure as by clinical practice	Procedure or surgery	control arm

Primary outcome

Perioperative blood loss (haemoglobin balance):
Time frame: Basal vs the first post operative day
The perioperative blood loss will be estimated by assessing the haemoglobin balance on the first postoperative day

6 secondary outcomes

Postoperative transfusion rate
Time frame: Perioperative time and postoperative time ( up to 60 days)
Postoperative blood loss
Time frame: Postoperatively (up to 2 days)
Blood loss after discharge
Time frame: at 5 and 15 days post hospital discharge
International Knee Documentation Committee objective
Time frame: Baseline, 30 and 60 days post treatment
Visual Analogue Scale - Pain
Time frame: baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);
Soft tissue status
Time frame: perioperatively, 30 and 60 days

Results and safety

The study was stopped early (reason given: Patient enrollment was proceeding slower than planned). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
Background: PubMed 25440395Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.
Background: PubMed 21512813Charoencholvanich K, Siriwattanasakul P. Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial. Clin Orthop Relat Res. 2011 Oct;469(10):2874-80. doi: 10.1007/s11999-011-1874-2. Epub 2011 Apr 22.
Background: PubMed 29939895Palanisamy JV, Das S, Moon KH, Kim DH, Kim TK. Intravenous Tranexamic Acid Reduces Postoperative Blood Loss After High Tibial Osteotomy. Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
Individual participant dataSharing planned: No

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?

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 6 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: stopped early, as of the sponsor's last update on 22 Jul 2025. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Patient enrollment was proceeding slower than planned). Results are not available in the source record.

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?

Perioperative blood loss (haemoglobin balance): (time frame: Basal vs the first post operative day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04785651, which also lists 3 linked publications.

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 22 Jul 2025.