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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of the Intraoperative Tourniquet Application Method on the Perioperative Blood Loss, Frequency of Transfusion and Close Postoperative Outcomes in Primary Total Knee Arthroplasty Patients

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Total knee arthroplasty performed under tourniquet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I tourniquet tactic<br>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. | Procedure: Total knee arthroplasty performed under tourniquet<br>* Comparison of the different tourniquet tactics.<br>* Other names: Volume loading test;|
| Other: II tourniquet tactic<br>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. | Procedure: Total knee arthroplasty performed under tourniquet<br>* Comparison of the different tourniquet tactics.<br>* Other names: Volume loading test;|
| Other: III tourniquet tactic<br>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 | Procedure: Total knee arthroplasty performed under tourniquet<br>* Comparison of the different tourniquet tactics.<br>* Other names: Volume loading test;|
| Other: IV control group<br>Do not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set. | Procedure: Total knee arthroplasty performed under tourniquet<br>* Comparison of the different tourniquet tactics.<br>* Other names: Volume loading test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss. | The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution. | Before (baseline) the surgery and 24 hrs postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | Within 6 days postoperatively | 
| Hemodilution |  | Within 6 days postoperatively | 
| Cardiac stroke volume |  | Within 6 days postoperatively | 
| Body temperature |  | Within 6 days postoperatively | 
| Pain (Visual Analog Scale) |  | Within 6 days postoperatively | 
| Number of opiate injections |  | Within 6 days postoperatively | 
| Straight-leg raising test |  | Within 6 days postoperatively | 
| Timed up and go test |  | Within 6 days postoperatively | 
| Knee flexion, extension, extension lag |  | Within 6 days postoperatively | 
| Knee swelling |  | Within 6 days postoperatively | 
| Complications |  | Within 6 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Tourniquet, Blood loss, Volume loading test