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Clinical Trials/NCT02429713
NCT02429713
Completed
Not Applicable

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

Peking University People's Hospital0 sites50 target enrollmentJanuary 2014
ConditionsBlood Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Blood Loss
Sponsor
Peking University People's Hospital
Enrollment
50
Primary Endpoint
Intraoperative blood loss
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wang Kai

resident

Peking University People's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Intraoperative blood loss

Time Frame: within operation

Secondary Outcomes

  • Thigh pain measured by Visual Analogue Scale/Score (VAS)(1 day, 2 day, 1 week, 2 week and 6 week after surgery)
  • Thigh swelling measured by circumference 10 cm proximal to the patella(1 day, 2 day, 1week, 2 week and 6 week after surgery)
  • Postoperative blood loss measured by drainage volume(1 day and 2 day after surgery)

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