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

NCT05581563 | Unknown

• 1 other identifier: mongislim2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

tourniquet use

ACTIVE COMPARATOR

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)

without tourniquet use

SHAM COMPARATOR

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)

Interventions

total knee arthroplasty(TKA) 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.

tourniquet use; without tourniquet use

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mongi Slim Hospital: lead

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the use of general anesthesia of all participants the outcomes assessor will not be able to have any information regarding tourniquet use
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, medical doctor, assistant professor

Model Details: Longitudinal Study Designs Cohort Study Simple randomisation with a 1:1 allocation ratio outcomes is measured after tourniquet use

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 14, 2022
• Study Start: October 10, 2022
• Primary Completion: October 10, 2023
• Study Completion: November 10, 2023
• Last Updated: October 14, 2022

Record last verified: 2022-10