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NCT Number: NCT02429713

The Effects of Tourniquet Use in Total Knee Arthroplasty

Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged 50 years or over
  • classified as American Society of Anesthesiologists ASA 1-2.

Exclusion criteria

  • coagulopathy,
  • uncontrolled hypertension,
  • peripheral vascular disease and
  • patients with BMI≥35

Treatment and study plan

Short-duration tourniquet

Procedure

Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening

Long-duration tourniquet

Procedure

Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement

Primary outcomes

  1. Intraoperative blood loss

    Time frame: within operation

Secondary outcomes

  1. Thigh pain measured by Visual Analogue Scale/Score (VAS)

    Time frame: 1 day, 2 day, 1 week, 2 week and 6 week after surgery

  2. Thigh swelling measured by circumference 10 cm proximal to the patella

    Time frame: 1 day, 2 day, 1week, 2 week and 6 week after surgery

  3. Postoperative blood loss measured by drainage volume

    Time frame: 1 day and 2 day after surgery

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2015
Registry last updated
Apr 29, 2015

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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