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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355900
• Other study ID #: NP-001
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: March 2, 2014
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.

Locations

Country	Name	City	State
Lithuania	Republic Vilnius University Hospital	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	Karolinska Institutet

Country where clinical trial is conducted

Lithuania, 

References & Publications (1)

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 — View Citation

Outcome

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