The Effects of Tourniquet Use in Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Blood Loss
• Interventions: Procedure: Short-duration tourniquet; Procedure: Long-duration tourniquet

• Registration Number: NCT02429713
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2015-04
• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-04-24
• Last Update Submitted: 2015-04-24
• Study First Posted: 2015-04-29
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Short-duration tourniquet group	Short-duration tourniquet	The tourniquet was inflated immediately before cement application and deflated after its hardening
Long-duration tourniquet group	Long-duration tourniquet	The tourniquet was inflated immediately before incision and deflated after the hardening of the cement

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	within operation

Secondary Outcome Measures

Name	Time	Method
Postoperative blood loss measured by drainage volume	1 day and 2 day after surgery
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