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Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

Primary Purpose

Monocompartimental Tibiofemoral Osteoarthritis, Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tibial osteotomy with Tranexamic acid
Tibial osteotomy without Tranexamic acid
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Monocompartimental Tibiofemoral Osteoarthritis focused on measuring tibial osteotomy, tranexamic acid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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;
  2. Known pro-thrombotic conditions (coagulation factor mutations, pregnancy status, previous pulmonary thromboembolism);
  3. BMI > 40;
  4. Incapacitated patients;
  5. Patients abusing alcoholic beverages, drugs or medication.
  6. Patients who are pregnant or breastfeeding.

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Tranexamic arm

control arm

Arm Description

Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.

Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative transfusion rate
the percentage of transfusions carried out in the two treatment groups will be determined;
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);
Blood loss after discharge
Post-discharge blood loss will be estimated by assessing haemoglobin balance at 5 and 15 days post-surgery;
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.
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'.
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

Full Information

First Posted
February 16, 2021
Last Updated
April 18, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT04785651
Brief Title
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies
Official Title
Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies: a Randomised Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
February 22, 2025 (Anticipated)
Study Completion Date
February 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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). 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monocompartimental Tibiofemoral Osteoarthritis, Osteoarthritis
Keywords
tibial osteotomy, tranexamic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic arm
Arm Type
Experimental
Arm Description
Patients in this arm will undergo to a tibial osteotomy in combination with the anti-fibrinolytic agent Tranexamic acid.
Arm Title
control arm
Arm Type
Other
Arm Description
Patients in this arm will undergo to a tibial osteotomy without the use of Tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Tibial osteotomy with Tranexamic acid
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tibial osteotomy without Tranexamic acid
Intervention Description
Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice
Primary Outcome Measure Information:
Title
Perioperative blood loss (haemoglobin balance):
Description
The perioperative blood loss will be estimated by assessing the haemoglobin balance on the first postoperative day
Time Frame
Basal vs the first post operative day
Secondary Outcome Measure Information:
Title
Postoperative transfusion rate
Description
the percentage of transfusions carried out in the two treatment groups will be determined;
Time Frame
Perioperative time and postoperative time ( up to 60 days)
Title
Postoperative blood loss
Description
The perioperative blood loss will be estimated by assessing the blood loss after surgery (through the volume of blood collected by drainage);
Time Frame
Postoperatively (up to 2 days)
Title
Blood loss after discharge
Description
Post-discharge blood loss will be estimated by assessing haemoglobin balance at 5 and 15 days post-surgery;
Time Frame
at 5 and 15 days post hospital discharge
Title
International Knee Documentation Committee objective
Description
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.
Time Frame
Baseline, 30 and 60 days post treatment
Title
Visual Analogue Scale - Pain
Description
visual analogue scale consisting of a straight line segment (10 cm long), the ends of which correspond to 'no pain' and 'strongest pain imaginable'.
Time Frame
baseline, 1 day post-treatment, 2 days post-treatment, 1 month, 2 months);
Title
Soft tissue status
Description
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
Time Frame
perioperatively, 30 and 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Andreani, M.Sc.
Phone
0516366567
Email
daniele.andreani@ior.it
First Name & Middle Initial & Last Name & Degree
Stefano Zaffagnini, Prof. MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25440395
Citation
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.
Results Reference
background
PubMed Identifier
21512813
Citation
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.
Results Reference
background
PubMed Identifier
29939895
Citation
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.
Results Reference
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Evaluation of the Use of Tranexamic Acid in Tibial Osteotomies

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