Phase 4
N=58
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Tibial Tubercle Osteotomy
Bottom Line
View on ClinicalTrials.gov: NCT03606109 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Perioperative Blood Loss — 67.8; 56.15 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (TXA) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative Blood Loss |
67.8; 56.15 | — |
| SECONDARY Score on Visual Analogue Scale (VAS) for Pain |
4.78; 4.77 | — |
| SECONDARY Score on Visual Analogue Scale (VAS) for Pain |
4.78; 4.77 | — |
| SECONDARY Score on Visual Analogue Scale (VAS) for Pain |
4.78; 4.77 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03606109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.