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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Total knee arthroplasty performed under tourniquet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, LT-04130
    • Republic Vilnius University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: I tourniquet tactic; 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; Comparison of the different tourniquet tactics.; Other Names: Volume loading test
OTHER: II tourniquet tactic; 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; Comparison of the different tourniquet tactics.; Other Names: Volume loading test
OTHER: III tourniquet tactic; 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; Comparison of the different tourniquet tactics.; Other Names: Volume loading test
OTHER: IV control group; 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; Comparison of the different tourniquet tactics.; Other Names: Volume loading test

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Narunas Porvaneckas, PhD, Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery

Publications and helpful links

General Publications

• Kvederas G, Porvaneckas N, Andrijauskas A, Svensen CH, Ivaskevicius J, Mazunaitis J, Marmaite U, Andrijauskas P. A randomized double-blind clinical trial of tourniquet application strategies for total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Dec;21(12):2790-9. doi: 10.1007/s00167-012-2221-1. Epub 2012 Sep 28.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (ESTIMATE): May 18, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 4, 2014
• Last Update Submitted That Met QC Criteria: March 2, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Tourniquet; Blood loss; Volume loading test
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NP-001