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Completed

NCT Number: NCT01355900

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Republic Vilnius University Hospital

Vilnius, LT-04130, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee arthroplasty performed under tourniquet

Procedure

Comparison of the different tourniquet tactics.

Other names: Volume loading test

Primary outcomes

  1. Perioperative blood loss.

    Time frame: 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 outcomes

  1. Wound healing

    Time frame: Within 6 days postoperatively

  2. Hemodilution

    Time frame: Within 6 days postoperatively

  3. Cardiac stroke volume

    Time frame: Within 6 days postoperatively

  4. Body temperature

    Time frame: Within 6 days postoperatively

  5. Pain (Visual Analog Scale)

    Time frame: Within 6 days postoperatively

  6. Number of opiate injections

    Time frame: Within 6 days postoperatively

  7. Straight-leg raising test

    Time frame: Within 6 days postoperatively

  8. Timed up and go test

    Time frame: Within 6 days postoperatively

  9. Knee flexion, extension, extension lag

    Time frame: Within 6 days postoperatively

  10. Knee swelling

    Time frame: Within 6 days postoperatively

  11. Complications

    Time frame: Within 6 days postoperatively

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 18, 2011
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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