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The effect of intramedullary injection of tranexamic acid on perioperative blood loss in robot-assisted total knee arthroplasty: a single-center, prospective, randomized controlled trial

The effect of intramedullary injection of tranexamic acid on perioperative blood loss in robot-assisted total knee arthroplasty: a single-center, prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086474
Enrollment
Unknown
Registered
2024-07-02
Start date
2024-07-08
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The robot-assisted total knee arthroplasty

Interventions

Intravenous administration group (utilizing a pneumatic tourniquet):Before making the skin incision, dissolve tranexamic acid (20mg/kg) in 100 ml of 0.9% sodium chloride for intravenous infusion (with
Intraosseous injection group (utilizing a tourniquet):After making the skin incision, drill into the medial side of the tibial tuberosity and the femoral medial condyle, reaching the cancellous bone.
Intravenous administration group (not using a tourniquet):Before making the skin incision, dissolve tranexamic acid (20mg/kg) in 100 ml of 0.9% sodium chloride for intravenous infusion (not using a to
Intraosseous injection group (not using a tourniquet):After making the skin incision, drill into the medial side of the tibial tuberosity and the femoral medial condyle, reaching the cancellous bone.

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.End-stage knee osteoarthritis, classified as Kellgren-Lawrence grade III or IV, with knee varus or valgus deformity less than 15° and flexion contracture less than 15°; 2.Scheduled for primary unilateral total knee arthroplasty; 3.Aged between 20 and 80 years, regardless of gender; 4.Normal preoperative blood routine and coagulation profiles; 5.Voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with an allergy to tranexamic acid; 2.Severe cardiovascular, cerebrovascular, pulmonary, renal, or hematologic diseases; 3.Preoperative anemia and coagulation disorders; 4.Use of anticoagulant and other antiplatelet medications within 1 week before surgery; 5.History of thrombosis, myocardial infarction, stroke, malignancy, or hypercoagulable states; 6.Underwent major orthopedic surgery within 1 month prior to admission.

Design outcomes

Primary

MeasureTime frame
C-reactive protein;Erythrocyte sedimentation rate;Blood RT;Coagulation function;Thrombosis of both lower limbs;Hospital for Special Surgery knee score;

Secondary

MeasureTime frame
Inflammatory factor panel;Bleeding event;VAS pain rating scale;

Countries

China

Contacts

Public ContactLi Cao

First Affiliated Hospital of Xinjiang Medical University

34956605@qq.com+86 139 0991 5960

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026