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sing tourniquet and IV tranexamic acid in unilateral Total Knee Arthroplasty (TKA) surgery

Phase 3
Recruiting
Conditions
Condition 1: Knee osteoarthritis. Condition 2: Unilateral total knee arthroplasty.
Unilateral primary osteoarthritis of knee
M17.1
Registration Number
IRCT20221228056952N1
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
168
Inclusion Criteria

Patients who refer to Ghaem hospital knee orthopedic clinic
Indicated for unilateral total knee arthroplasty (TKA) surgery

Exclusion Criteria

allergy to TXA
Active thromboembolic disease
Seizure disorder
Prior cerebrovascular accident
Cardiac stents or a history of thromboembolic disease
Prior renal disorder (glomerular filtration rate < 30 ml/min/1.73m2)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Blood loss volume. Timepoint: After surgery. Method of measurement: Postoperatively, blood loss will be calculated on the basis of the validated Gross formula, which includes sex, height, and weight, as well as pre-operative and postoperative day 2 hematocrit values with correction for any volume of blood administered.;Surgeon satisfaction with visualization during the procedure. Timepoint: After surgery. Method of measurement: Using a 10-point visualization scale, with 0 categorized as ‘‘poor’’ and 10 categorized as ‘‘good.’’ This will be completed by the operative surgeon at the end of the case.;Clinical outcomes. Timepoint: 2 and 6 months follow-up after surgery. Method of measurement: Pain score using Visual analogue scale (VAS), a 10-point visualization scale. Knee functional questionnaires of Oxford Knee Score, and WOMAC.
Secondary Outcome Measures
NameTimeMethod
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