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

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Narunas Porvaneckas, Vilnius University
ClinicalTrials.gov Identifier:
NCT01355900
First received: May 16, 2011
Last updated: March 2, 2014
Last verified: March 2014

May 16, 2011
March 2, 2014
January 2010
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01355900 on ClinicalTrials.gov Archive Site
  • 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 ]
Functional and clinical outcomes. [ Time Frame: Within 6 days postoperatively ] [ Designated as safety issue: No ]

Measure:

Hemodilution Cardiac stroke volume Body temperature Pain (VAS) Number of opiate injections Straight-leg raising test Timed up and go test Knee flextion, extension, extension lag Knee swelling Wound healing Complications

Not Provided
Not Provided
 
Comparison of Three Tourniquet Application Methods in Primary Total Knee Arthroplasty Surgery
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
Procedure: Total knee arthroplasty performed under tourniquet
Comparison of the different tourniquet tactics.
Other Name: Volume loading test
  • 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.
    Intervention: Procedure: Total knee arthroplasty performed under tourniquet
  • 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.
    Intervention: Procedure: Total knee arthroplasty performed under tourniquet
  • 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
    Intervention: Procedure: Total knee arthroplasty performed under tourniquet
  • 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.
    Intervention: Procedure: Total knee arthroplasty performed under tourniquet
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. 2012 Sep 28. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Lithuania
 
NCT01355900
NP-001
No
Narunas Porvaneckas, Vilnius University
Vilnius University
Karolinska Institutet
Principal Investigator: Narunas Porvaneckas, PhD Medical Faculty of Vilnius University, Clinic of Rheumatology, Traumatology and reconstructive surgery
Vilnius University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP