The Effects of Tourniquet Use in Total Knee Arthroplasty

NCT02429713 | Completed

• 1 other identifier: PekingUPH
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Loss

Keywords

tourniquet; total knee arthroplasty; blood loss

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  within operation

Secondary Outcomes (3)

• 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

Study Arms (2)

Short-duration tourniquet group

EXPERIMENTAL

The tourniquet was inflated immediately before cement application and deflated after its hardening

Procedure: Short-duration tourniquet

Long-duration tourniquet group

ACTIVE COMPARATOR

The tourniquet was inflated immediately before incision and deflated after the hardening of the cement

Procedure: Long-duration tourniquet

Interventions

Short-duration tourniquet PROCEDURE

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

Short-duration tourniquet group

Long-duration tourniquet PROCEDURE

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

Long-duration tourniquet group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (2)

• 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.

  PMID: 21161177 BACKGROUND

• Hernandez AJ, Almeida AM, Favaro 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. doi: 10.6061/clinics/2012(09)12.

  PMID: 23018303 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianhao Lin, M.D.

  Peking University People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: April 29, 2015
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2015-04