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

NCT ID: NCT05581563

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2023-11-10

Brief Summary

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

Detailed 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

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

tourniquet use

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

Group Type: ACTIVE_COMPARATOR

total knee arthroplasty(TKA)

Intervention Type: PROCEDURE

Knee replacement, also called knee arthroplasty or total knee replacement, is a surgical procedure to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint, along with the kneecap. This surgery may be considered for someone who has severe arthritis or a severe knee injury.

without tourniquet use

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

Group Type: SHAM_COMPARATOR

total knee arthroplasty(TKA)

Intervention Type: PROCEDURE

Knee replacement, also called knee arthroplasty or total knee replacement, is a surgical procedure to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint, along with the kneecap. This surgery may be considered for someone who has severe arthritis or a severe knee injury.

Interventions

total knee arthroplasty(TKA)

Knee replacement, also called knee arthroplasty or total knee replacement, is a surgical procedure to resurface a knee damaged by arthritis. Metal and plastic parts are used to cap the ends of the bones that form the knee joint, along with the kneecap. This surgery may be considered for someone who has severe arthritis or a severe knee injury.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mongi Slim Hospital

OTHER

Sponsor Role: lead

Responsible Party

mohamed hedi ezzine

Principal Investigator, medical doctor, assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

mongislim2

Identifier Type: -

Identifier Source: org_study_id