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The Effects of Tourniquet Use in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02429713
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
Wang Kai, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Blood Loss Procedure: Short-duration tourniquet Procedure: Long-duration tourniquet Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial
Study Start Date : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short-duration tourniquet group
The tourniquet was inflated immediately before cement application and deflated after its hardening
Procedure: Short-duration tourniquet
Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening

Active Comparator: Long-duration tourniquet group
The tourniquet was inflated immediately before incision and deflated after the hardening of the cement
Procedure: Long-duration tourniquet
Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement




Primary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: within operation ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429713


Sponsors and Collaborators
Peking University People's Hospital
Investigators
Study Director: Jianhao Lin, M.D. Peking University People's Hospital

Publications:
Responsible Party: Wang Kai, resident, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02429713     History of Changes
Other Study ID Numbers: PekingUPH
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: April 2015

Keywords provided by Wang Kai, Peking University People's Hospital:
tourniquet
total knee arthroplasty
blood loss

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes