Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- total estimated blood loss
研究概览
简要总结
Tourniquet application in total knee arthroplasty has many benefits and might have a role in the incidence of peri-operative complications the aim of this research: is to look into the effectiveness of the limited application of tourniquet during primary unilateral total knee arthroplasty and compare the perioperative complications with the standard full-time application.
详细描述
Tourniquet application has been a routine choice for most joint surgeons around the world, reducing intra-operative blood loss and the better clearance of the surgical field and the better cementation technique with a blood-free cancellous bone are the main benefits, while the possible negatives are the pain of the thigh, skin burns, neurovascular complications and possibly increased risk of VTE, and the literature states a new orientation towards reducing the time of application of tourniquet or even eliminating it, favoring avoiding its risks rather than captivating its benefits so the investigator conducted a prospective randomized double-blinded controlled study, and enrolled 62 patients between the beginning of 2021 and august,2022.
after obtaining informed consent and approval by the institutional review board, the study was done in Damascus Syria, the investigator followed up every patient for six months, Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups, and the allocation was put into concealed envelopes independent of the surgeon and the author and the randomization was performed by a research fellow who was not involved in patient care, the tourniquet was applicated around the proximal thigh in all patients, the first group went unilateral primary TKA with inflating the tourniquet prior to incision and releasing it after closure and compression bandage application, while the second group went primary unilateral TKA with the tourniquet inflated only during cementation and final components application, the procedures were done under general, spinal or regional anesthesia based on the anesthetist consultant, a based-on-weight tranexamic acid dose was given intravenously before incision, all procedures was done by the same surgeon using the medial para-patellar approach , and the protheses used in all patients were cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides were uses for the femoral and tibial cuts, the patients were blinded to the intervention during the whole period of the study, while the surgeon and the author were unblinded by opening the envelope by a research member just before initiating anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups, and the allocation was put into concealed envelopes independent of the surgeon and the author, and the randomization was performed by a research fellow who was not involved in patient care, the patients were blinded to the intervention during the whole period of the study, while the surgeon and the author were unblinded by opening the envelope by a research member just before initiating anesthesia, the data was collected by the author's assistant who was blinded of the intervention during the whole period of the study
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
- 是
入选标准
- •patients between 50 and 85 years of age with end-stage knee arthritis going primary unilateral TKA after the failure of conservative treatment.
排除标准
- •o Patients younger than 50y and older than 85y.
- •BMI less than 20 and more than
- •Patients having a vascular or hematologic disease.
- •Patients who were taking anti-coagulant medicine and can't stop it.
- •Patients having acute or chronic renal failure.
- •Patients classified as the AAA as grade four or five.
- •Post-traumatic and secondary knee arthritis patients.
- •Revisions and complex primary cases.
- •Patients with an active infection or a history of lower limp infection.
结局指标
主要结局
total estimated blood loss
时间窗: measured once 2 days after surgery
the total amount of lost blood in the perioperative period and will be calculated using the Gross formula which is estimated by hitting the patients' blood volume by the difference between pre and post-operative hematocrit value divided by the initial hematocrit value
intra-operative blood loss
时间窗: measured once by the time of closure of the incision
the amount of lost blood intraoperatively and will be measured by calculating the increased weight of the utilized wet mops and the volume of the suction bottle after erasing the amount of the used lavage
post-operative blood loss
时间窗: measured once 2 days after surgery
the amount of lost blood postoperatively will be calculated as the output of the drain bottle
hidden blood loss
时间窗: measured once 2 days after surgery
the amount of lost blood in the tissues that were not measured intraoperatively or postoperatively and will be calculated using the difference between total blood loss and intra and post-operative blood loss
次要结局
- duration of surgery(measured once at the time of bandage application after closure)
- surgical field clearance(measured once by the time of closure of incision)
- perioperative complications(assessed within two weeks intervals until 6 months after surgery)