Clinical and Functional Outcomes of Tourniquet Use in Primary Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- International Knee Documentation Committee 2000
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
the use of general anesthesia of all participants the outcomes assessor will not be able to have any information regarding tourniquet use
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis Kellgren and Lawrence score III or IV
- •Written consent
- •Total knee arthroplasty
排除标准
- •Neurological dysfunction
- •Coagulation disorder
- •Glucocorticoids, aspirin, heparin, coumadine, warfarin
- •History of pulmonary embolism
结局指标
主要结局
International Knee Documentation Committee 2000
时间窗: 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
时间窗: 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
时间窗: Hospital admission to discharge (about 3 days)
intraoperative blood loss estimation in ml added to postoperative drainage
Oxford Score (OS)
时间窗: 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)
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
mohamed hedi ezzine
Principal Investigator, medical doctor, assistant professor
Mongi Slim Hospital