The Effects of Tourniquet Use in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

Detailed Description
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Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.

Official Title
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The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial

Conditions
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Blood Loss

Intervention / Treatment
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* Procedure: Short-duration tourniquet
* Procedure: Long-duration tourniquet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 50 years or over classified as American Society of Anesthesiologists ASA 1-2. Exclusion Criteria: coagulopathy, uncontrolled hypertension, peripheral vascular disease and patients with BMI≥35

Ages Eligible for Study
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Minimum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short-duration tourniquet group<br>The tourniquet was inflated immediately before cement application and deflated after its hardening | Procedure: Short-duration tourniquet<br>* Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening<br>|
| Active Comparator: Long-duration tourniquet group<br>The tourniquet was inflated immediately before incision and deflated after the hardening of the cement | Procedure: Long-duration tourniquet<br>* Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss |  | within operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thigh pain measured by Visual Analogue Scale/Score (VAS) |  | 1 day, 2 day, 1 week, 2 week and 6 week after surgery | 
| Thigh swelling measured by circumference 10 cm proximal to the patella |  | 1 day, 2 day, 1week, 2 week and 6 week after surgery | 
| Postoperative blood loss measured by drainage volume |  | 1 day and 2 day after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tourniquet, total knee arthroplasty, blood loss