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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Procedure: total knee arthroplasty(TKA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Longitudinal Study Designs Cohort Study Simple randomisation with a 1:1 allocation ratio outcomes is measured after tourniquet use
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tourniquet use<br>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)<br>* 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.<br>|
| Sham Comparator: without tourniquet use<br>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)<br>* 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.<br>|

What is the study measuring?
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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 |