The Effects of Tourniquet Use in Total Knee Arthroplasty

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429713
• Other study ID #: PekingUPH
• Status: Completed
• Phase: N/A
• First received: April 15, 2015
• Last updated: April 24, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Procedure:
• Short-duration tourniquet
Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening
• Long-duration tourniquet
Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (2)

Hernandez AJ, Almeida AM, Fávaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. — View Citation

Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss		within operation	No
Secondary	Thigh pain measured by Visual Analogue Scale/Score (VAS)		1 day, 2 day, 1 week, 2 week and 6 week after surgery	No
Secondary	Thigh swelling measured by circumference 10 cm proximal to the patella		1 day, 2 day, 1week, 2 week and 6 week after surgery	No
Secondary	Postoperative blood loss measured by drainage volume		1 day and 2 day after surgery	No