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

NCT ID: NCT01355900

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-01-31

Brief Summary

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

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: OTHER

Total knee arthroplasty performed under tourniquet

Intervention Type: PROCEDURE

Comparison of the different tourniquet tactics.

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.

Group Type: OTHER

Total knee arthroplasty performed under tourniquet

Intervention Type: PROCEDURE

Comparison of the different tourniquet tactics.

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

Group Type: OTHER

Total knee arthroplasty performed under tourniquet

Intervention Type: PROCEDURE

Comparison of the different tourniquet tactics.

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.

Group Type: OTHER

Total knee arthroplasty performed under tourniquet

Intervention Type: PROCEDURE

Comparison of the different tourniquet tactics.

Interventions

Total knee arthroplasty performed under tourniquet

Comparison of the different tourniquet tactics.

Intervention Type: PROCEDURE

Other Intervention Names

Volume loading test

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Narunas Porvaneckas

Pofessor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Narunas Porvaneckas, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery

Locations

Republic Vilnius University Hospital

Vilnius, , Lithuania

Countries

Lithuania

References

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.

Reference Type: RESULT

PMID: 23052115 (View on PubMed)

Other Identifiers

NP-001

Identifier Type: -

Identifier Source: org_study_id