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临床试验/NCT02701946
NCT02701946已完成不适用

Efficacy of Modified Robert Jones Bandages on Reducing Invisible Blood Loss After Total Knee Arthroplasty: A Randomized Controlled Trial

Mahidol University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Invisible blood loss after surgery

研究概览

简要总结

Total knee arthroplasty (TKA) is one of the most successful procedures in orthopaedic surgery. Nevertheless, significant postoperative blood loss and requirement of blood transfusion are still problematic. Total blood loss in TKA can be divided into visible and invisible blood loss. Visible blood loss (VBL) means blood loss from the surgical field and wound drainage while invisible blood loss (IBL) means residual blood in the knee, extravasation into the tissues and loss due to haemolysis.

In usual practice, TKA is performed with a bloodless field using a tourniquet. Thus intraoperative blood loss can be negligible and postoperative drainage is only considered as VBLvisible. In terms of IBL, Sehat et al. found that TKA carried a substantial IBL. Their results shown the mean IBL was 765 ml or 49% of the mean total blood loss after TKA. Therefore, the true total blood loss was underestimated if not takes IBL into account.

Modified Robert Jones bandage (MRJB) is a bulky compressive dressing that often used in orthopaedic practice. Various techniques of application have been proposed.

From the previous study, MRJB could make and maintain the anterolateral muscle compartment pressure for at least 24 hours after TKA. Therefore, theoretically, this bandage can cause the tamponade effect that helps to reduce tissue edema and postoperative bleeding especially IBL after TKA. However this potential benefit of MRJB is unclear and the use of this bandage after TKA is still controversy in clinical practice.

详细描述

In preoperative period, all eligible participants are admitted to the hospital for undergoing TKA. The detailed protocol, including how to rate visual analog pain score, times to take the blood for checking hematocrit levels, criteria for blood transfusion, time to measure the knee and thigh circumferences and plan of ambulation program, is informed again. The routine preoperative preparation is done. The participant is asked for answering preoperative Oxford Knee Score questionnaire. Participants' baseline characteristics are also recorded.

During intraoperative period, all participants receive the same anesthetic method (spinal anesthesia without morphine and peripheral nerve block). Two experienced surgeons (CK and NR) perform all procedure with the same surgical technique. A 750 mg intravenous tranexamic acid is administrated before inflating tourniquet and 3 hours after the operation. A tourniquet pressure of 300 mmHg is used and inflated before skin incision. Pre-incisional local injection with 10 ml of 1% lidocaine with adrenaline is done. A mini-medial parapatellar approach is performed. Cemented TKA prostheses (Nexgen LPS-Flex, Zimmer, Warsaw, Indiana) are implanted in all participants without patellar resurfacing. Periarticular analgesic injection is done with 20 ml of 0.5% bupivacaine, 20 ml of normal saline, 30 mg of ketorolac and 1 ml of 1% lidocaine with adrenaline. A number-10-gauge drain is placed intra-articularly and connected to the Ultravak pressure drainage bottle (Poly Medicure Limited, India). Extensor mechanisms are repaired and the wound closure is performed in the routine fashion.

At the end of operation, the randomized sequence is opened by a scrub nurse. Then, the participants are randomly assigned into two groups; Group 1 or MRJB group and Group 2 or non-compressive dressing (NCD) group. A tourniquet pressure is deflated after the dressing is applied.

In postoperative period, MRJB is left in place for 24 hours and then changed to NCD. All participants obtain the three-hour interval drain clamping protocol. After tourniquet release, the drain is clamped for three hours, released for three hours, re-clamped for three hours, and then the clamp is run continuously. Mechanical prophylaxis of deep vein thrombosis by ankle pumping exercise and ambulation on the bed is started as soon as possible. After 24 hours postoperatively, range of motion exercise and out-of-bed ambulation program are started. Ice packs are placed around the knee for at least 8 hours per day. The drain is removed at 48 hours after operation.

For operational definition, MRJB is defined as a three-layers of thick cotton wool and two-layers of elastic bandages. The wool layers are put on firmly and overlapped the previous one by half at each turn. The elastic layers were pulled snugly with more tension distally than proximally. Before wrapping in each turn, the elastic bandage was stretched approximately 2 and 1.5 inches at below and above tibial tuberosity level, respectively. The whole bandage attains a thickness of about two inches and extends above the ankle joint to six inches above the knee joint. Before applying this bandage, the sterile gauze pads were placed over the wound and followed by WebrilTM padding (Covidien, Mansfield, MA, US). While NCD is made by placing the sterile gauze pads over the wound and covering with the hypoallergenic self-adhesive, non-woven fabric tape.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who diagnosed primary osteoarthritis of knee and scheduled for primary unilateral total knee arthroplasty
  • Patients aged more than 18 years

排除标准

  • Patients who have a history of coagulopathy
  • Patients who receive antiplatelet drug in the previous week
  • Patients who treated other conditions with anticoagulant drug
  • Patients who have previous history of thromboembolic event
  • Patients who have vascular compromise of the operated limb
  • Patients who have chronic kidney disease or liver cirrhosis
  • Patients who refuse to participate the study
  • Patients who have allergy to tranexamic acid, sulfa or morphine
  • Patients who have blood loss per wound after surgery
  • Patients who can not receive spinal anesthesia and peripheral nerve block

研究组 & 干预措施

Modified Robert Jones bandage

Experimental

Modified Robert Jones bandage is defined as a three-layers of thick cotton wool and two-layers of elastic bandages. The wool layers are put on firmly and overlapped the previous one by half at each turn. The elastic layers were pulled snugly with more tension distally than proximally. Before wrapping in each turn, the elastic bandage was stretched approximately 2 and 1.5 inches at below and above tibial tuberosity level, respectively. The whole bandage attains a thickness of about two inches and extends above the ankle joint to six inches above the knee joint. Before applying this bandage, the sterile gauze pads were placed over the wound and followed by WebrilTM padding (Covidien, Mansfield, MA, US).

干预措施: Modified Robert Jones bandage (Procedure)

Non compressive dressing

Placebo Comparator

Non-compressive dressing is made by placing the sterile gauze pads over the wound and covering with the hypoallergenic self-adhesive, non-woven fabric tape.

干预措施: Non compressive dressing (Procedure)

结局指标

主要结局

Invisible blood loss after surgery

时间窗: 48 hours after surgery

Time (seconds) taken to perform time up and go test

时间窗: 6 weeks after surgery

meters, turn, walk back to the chair, then sit down.

次要结局

  • Score from Oxford knee score questionnaire(6 weeks after surgery)
  • Complication(6 weeks after surgery)
  • Circumferences of knee(48 hours after surgery)
  • Postoperative visual analog pain score(48 hours after surgery)
  • Circumferences of thigh(48 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chaturong Pornrattanamaneewong

Clinical instructor

Mahidol University

研究点 (2)

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