Knee Osteoarthritis
Conditions
Keywords
Total knee arthroplasty, Tourniquet, Blood loss, Volume loading test
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.
Interventions
PROCEDURETotal knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Sponsors
Karolinska Institutet
Vilnius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative blood loss. | Before (baseline) the surgery and 24 hrs postoperatively | The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Wound healing | 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 |
| Straight-leg raising test | Within 6 days postoperatively |
Countries
Lithuania
Outcome results
None listed