Clinical trial NCT01355900: Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total knee arthroplasty
Tourniquet
Blood loss
Volume loading test
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2011-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perioperative blood loss.
timeFrame: Before (baseline) the surgery and 24 hrs postoperatively
Secondary outcomes:
measure: Wound healing
timeFrame: Within 6 days postoperatively
measure: Hemodilution
timeFrame: Within 6 days postoperatively
measure: Cardiac stroke volume
timeFrame: Within 6 days postoperatively
measure: Body temperature
timeFrame: Within 6 days postoperatively
measure: Pain (Visual Analog Scale)
timeFrame: Within 6 days postoperatively
measure: Number of opiate injections
timeFrame: Within 6 days postoperatively
measure: Straight-leg raising test
timeFrame: Within 6 days postoperatively
measure: Timed up and go test
timeFrame: Within 6 days postoperatively
measure: Knee flexion, extension, extension lag
timeFrame: Within 6 days postoperatively
measure: Knee swelling
timeFrame: Within 6 days postoperatively
measure: Complications
timeFrame: Within 6 days postoperatively
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Republic Vilnius University Hospital
Study officials:
affiliation: Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery
name: Narunas Porvaneckas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.