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Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee Arthroplasty
Sponsor: The Second Affiliated Hospital of Kunming Medical University
Summary
This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.
Official title: Efficacy and Safety of Local Intraosseous Tranexamic Acid Injection for Reducing Perioperative Blood Loss in Total Knee Arthroplasty: A Randomized, Double-Blind, Controlled Trial
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-10
Completion Date
2027-07
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Tranexamic Acid
A total dose of 2 g of tranexamic acid will be administered by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Of the total dose, 1 g will be injected into the cancellous bone of the tibial plateau, and 1 g will be injected into the medial and lateral condyles of the distal femur. The intervention will be administered using a standardized intraosseous injection technique.
Normal Saline
Normal saline will be administered by the same local intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty. The volume, injection sites, timing, and administration procedure will be matched to those used in the experimental group.
Locations (1)
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China