The Effects of Tourniquet Use in Total Knee Arthroplasty

NCT ID: NCT02429713

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Short-duration tourniquet group

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

Group Type: EXPERIMENTAL

Short-duration tourniquet

Intervention Type: PROCEDURE

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

Long-duration tourniquet group

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

Group Type: ACTIVE_COMPARATOR

Long-duration tourniquet

Intervention Type: PROCEDURE

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

Interventions

Short-duration tourniquet

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

Intervention Type: PROCEDURE

Long-duration tourniquet

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Kai

resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianhao Lin, M.D.

Role: STUDY_DIRECTOR

Peking University People's Hospital

References

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.

Reference Type: BACKGROUND

PMID: 21161177 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23018303 (View on PubMed)

Other Identifiers

PekingUPH

Identifier Type: -

Identifier Source: org_study_id