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

Not Applicable

Not yet recruiting

• Conditions: Total Knee Arthroplasty
• Interventions: Procedure: total knee arthroplasty(TKA)

• Registration Number: NCT05581563
• Lead Sponsor: Mongi Slim Hospital

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

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-01
• Study Start: 2022-10-10
• Study First Submitted QC: 2022-10-13
• Last Update Submitted: 2022-10-13
• Study First Posted: 2022-10-14
• Last Update Posted: 2022-10-14
• Primary Completion: 2023-10-10
• Study Completion: 2023-11-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without tourniquet use	total knee arthroplasty(TKA)	knee replacement surgery without the aid of a tourniquet - a tight band placed around the thigh that restricts blood flow to the knee.
tourniquet use	total knee arthroplasty(TKA)	knee replacement surgery with the aid of a tourniquet - a tight band placed around the thigh that restricts blood flow to the knee.

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee 2000	Month 6	International Knee Documentation Committee (IKDC) 2000 subjective score The score is interpreted as a measure of function such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with activities of daily living or sports activities and the absence of symptoms.
Lysholm score	Month 6	The Lysholm Scale currently consists of eight items that measure: pain (25 points), instability (25 points), locking (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting (5 points), and need for support (5 points). Every question response has been assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disabilities
perioperative blood loss	Hospital admission to discharge (about 3 days)	intraoperative blood loss estimation in ml added to postoperative drainage
Oxford Score (OS)	Month 6	This score is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks.; the scoring system from 0-4 where four is the best outcome and total scores range from 0 (poorest function) to 48 (maximal function)
Visual Analogue Scale (VAS)	Day 2	Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
quadriceps area circumference	Month 6	Measurement of thigh is usually performed 15 cm proximal to the superior pole of the patella. The thigh circumference is measured in cm with a measurement tape and compared to the normal contralateral knee to determine the amount of quadriceps atrophy present