Clinical and Functional Outcomes of Tourniquet Use in Primary Total Knee Arthroplasty

Mongi Slim Hospital

Status: Not yet enrolling

Conditions: Total Knee Arthroplasty

Treatments: Procedure: total knee arthroplasty(TKA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05581563

mongislim2

Details and patient eligibility

About

Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery

Full description

randomized controlled trials , comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: post-operative pain measure with analogue visual scale function with Oxford Score , Lysholm score and International Knee Documentation Committee Score intraoperative blood loss measurement of quadriceps tonus in pre- and post-operative according to the international rating measurement of quadriceps area circumference duration of surgery, and length of hospital stay

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Osteoarthritis Kellgren and Lawrence score III or IV
• Written consent
• Total knee arthroplasty

Exclusion criteria

• Neurological dysfunction
• Coagulation disorder
• Glucocorticoids, aspirin, heparin, coumadine, warfarin
• History of pulmonary embolism

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

tourniquet use

Active Comparator group

Description:

knee replacement surgery with the aid of a tourniquet - a tight band placed around the thigh that restricts blood flow to the knee.

Treatment:

Procedure: total knee arthroplasty(TKA)

without tourniquet use

Sham Comparator group

Description:

knee replacement surgery without the aid of a tourniquet - a tight band placed around the thigh that restricts blood flow to the knee.

Treatment:

Procedure: total knee arthroplasty(TKA)