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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Procedure: total knee arthroplasty(TKA)

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Sham Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	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).	Baseline
Visual Analogue Scale (VAS)	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).	Day 1
Visual Analogue Scale (VAS)	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).	Day 2
International Knee Documentation Committee 2000	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.	Baseline
International Knee Documentation Committee 2000	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.	Month 3
International Knee Documentation Committee 2000	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.	Month 6
Oxford Score (OS)	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)	Baseline
Oxford Score (OS)	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)	Month 3
Oxford Score (OS)	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)	Month 6
Lysholm score	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	Baseline
Lysholm score	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	Month 3
Lysholm score	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	Month 6
perioperative blood loss	intraoperative blood loss estimation in ml added to postoperative drainage	Hospital admission to discharge (about 3 days)
quadriceps area circumference	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	Baseline
quadriceps area circumference	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	Month 3
quadriceps area circumference	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	Month 6

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 10, 2022
• Primary Completion (Anticipated): October 10, 2023
• Study Completion (Anticipated): November 10, 2023

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: mongislim2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No