Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
- Conditions
- Knee Osteoarthritis
- Interventions
- Procedure: Total knee arthroplasty performed under tourniquet
- Registration Number
- NCT01355900
- Lead Sponsor
- Vilnius University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I tourniquet tactic Total knee arthroplasty performed under tourniquet 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. II tourniquet tactic Total knee arthroplasty performed under tourniquet 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. III tourniquet tactic Total knee arthroplasty performed under tourniquet 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 IV control group Total knee arthroplasty performed under tourniquet Do not use volume loading test. Total knee arthroplasty performed under tourniquet. Lower limb tourniquet inflation- before cement application, deflation- after bone cement set.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Republic Vilnius University Hospital
🇱🇹Vilnius, Lithuania