Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Tibial Tubercle Osteotomy

Treatments: Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03606109

18-00535

Details and patient eligibility

About

The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.

Full description

Not Provided

Enrollment: 58 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing TTO
• Age 18-60
• Willing and able to provide consent

Exclusion criteria

• Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
• Younger than 18 years of age
• Older than 60 years of age
• Any patient considered a vulnerable subject
• Have bleeding or clotting disorder
• Preoperative anticoagulation therapy
• Abnormal coagulation profile
• Renal disorder or insufficiency
• Sickle cell disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

High Tibial Osteotomy (HTO)

Active Comparator group

Treatment:

Drug: Tranexamic Acid (TXA)

Tibial Tubercle Ostetomy (TTO)

Active Comparator group

Treatment:

Drug: Tranexamic Acid (TXA)