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The Effects of Tourniquet Use in Total Knee Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02429713
Enrollment
50
Registered
2015-04-29
Start date
2014-01-31
Completion date
2015-03-31
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss

Keywords

tourniquet, total knee arthroplasty, blood loss

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.

Interventions

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

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

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Intraoperative blood losswithin operation

Secondary

MeasureTime frame
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 patella1 day, 2 day, 1week, 2 week and 6 week after surgery
Postoperative blood loss measured by drainage volume1 day and 2 day after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026