Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery

Vilnius University

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Procedure: Total knee arthroplasty performed under tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT01355900

NP-001

Details and patient eligibility

About

Different strategies of tourniquet application during elective primary total knee arthroplasty are thought to be associated with different outcomes. In that context, the study investigates different tactics in the search of optimal application of the tourniquet and the related fluid management during 24 perioperative hours.

Full description

The optimal application of tourniquet should reduce perioperative blood loss, create bloodless operative field, improve cementing technique and shorten surgery time. Meanwhile, inadequate application may increase the risk of deep vein thrombosis and pulmonary thromboembolism. Previous attempts to compare the tourniquet strategies in respect to the perioperative blood loss did not show significant difference. The investigators use the volume loading test aiming to optimize the fluid status and obtain the hemoglobin concentration in the conditions of standardized plasma dilution. The test is deployed just before the surgery and after postoperative 24 hrs in ICU. Functional outcomes and possible length of hospital stay is also evaluated.

Enrollment: 120 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with osteoarthritis of the knee undergoing total knee arthroplasty with spinal-epidural anesthesia
• Age > 50 and < 80 years
• ASA (American Society of Anesthesiology Classification) II physical status
• Signed informed consent form

Exclusion criteria

• History of a bleeding disorder
• Current chronic anticoagulation therapy
• History of DVT (Deep Vein Thrombosis), thromboembolic complications, acute cardiac insufficiency
• Anemia before surgery required blood transfusion
• ASA I, ASA>=III physical status
• Age < 50 and > 80 years
• BMI (Body Mass Index) < 20 and > 40kg/m2
• Intravascular fluid infusion within 24 hours before study
• Chronic non-steroidal anti-inflammatory drug use (more than 6month daily use)
• Rheumatoid arthritis
• Diabetes mellitus
• Psychiatric illness (intake of other psychiatric medication than selective serotonin reuptake inhibitors)
• Alcohol intake 5 U daily
• Contraindication to epidural catheter insertion
• Surgery not by project surgeon
• Participation in the other study
• Active malignancy
• Previous open knee surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

I tourniquet tactic

Other group

Description:

Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after bone cement set.

Treatment:

Procedure: Total knee arthroplasty performed under tourniquet

II tourniquet tactic

Other group

Description:

Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.

Treatment:

Procedure: Total knee arthroplasty performed under tourniquet

III tourniquet tactic

Other group

Description:

Use volume loading test twice (before surgery and 24hrs postoperatively). Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before incision, deflation- after wound closure

Treatment:

Procedure: Total knee arthroplasty performed under tourniquet

IV control group

Other group

Description:

Do not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.

Treatment:

Procedure: Total knee arthroplasty performed under tourniquet