Text Size

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

This study is currently recruiting participants.
Verified February 2013 by Vilnius University
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Narunas Porvaneckas, Vilnius University
ClinicalTrials.gov Identifier:
NCT01355900
First received: May 16, 2011
Last updated: February 24, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
 Procedure: Total knee arthroplasty performed under tourniquet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vilnius University:

Primary Outcome Measures:
  • Perioperative blood loss. [ Time Frame: Before (baseline) the surgery and 24 hrs postoperatively ] [ Designated as safety issue: No ]
    The volume loading test is deployed for the comparison of perioperative hemoglobin in the standardized plasma dilution.


Secondary Outcome Measures:
  • Wound healing [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Hemodilution [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Cardiac stroke volume [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Body temperature [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Pain (Visual Analog Scale) [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Number of opiate injections [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Straight-leg raising test [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Timed up and go test [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Knee flexion, extension, extension lag [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Knee swelling [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Name: Volume loading test
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.
 Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Name: Volume loading test
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
 Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Name: Volume loading test
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.
 Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Name: Volume loading test

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355900

Contacts
Contact: Narunas Porvaneckas, PhD 46404 ext 370698 narunas.porvaneckas@mf.vu.lt
Contact: Audrius Andrijauskas, PhD 71459 ext 370652 audrius.andrijauskas@mf.vu.lt

Locations
Lithuania
Republic Vilnius University Hospital Recruiting
Vilnius, Lithuania, LT-04130
Contact: Narunas Porvaneckas, PhD     46404 ext 370698     narunas.porvaneckas@mf.vu.lt    
Contact: Audrius Andrijauskas, PhD     71459 ext 370652     audrius.andrijauskas@mf.vu.lt    
Principal Investigator: Narunas Porvaneckas, PhD            
Sponsors and Collaborators
Vilnius University
Karolinska Institutet
Investigators
Principal Investigator: Narunas Porvaneckas, PhD Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery
  More Information

Publications:

Responsible Party: Narunas Porvaneckas, Pofessor, PhD, Vilnius University
ClinicalTrials.gov Identifier: NCT01355900     History of Changes
Other Study ID Numbers: NP-001
Study First Received: May 16, 2011
Last Updated: February 24, 2013
Health Authority: Lithuania: Bioethics Committee

Keywords provided by Vilnius University:
Total knee arthroplasty
Tourniquet
Blood loss
Volume loading test

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013