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临床试验/NCT04502459
NCT04502459已完成不适用

A Prospective Randomized Trial on the Use of Tourniquet in Primary Total Knee Arthroplasty

The University of Hong Kong0 个研究点目标入组 90 人开始时间: 2015年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
Blood Loss

研究概览

简要总结

A tourniquet is often used in total knee arthroplasty (TKA) to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation. On the other hand, the associated risks include skin burns, soft tissue and muscle damage, injury of calcified vessels, increased swelling and stiffness of the joints, nerve injury, paralysis, and thromboembolic events. The automatic lower limb pneumatic tourniquet system (Zimmer) was applied to reduce blood loss during surgery. A prospective randomized controlled trial (RCT) was performed to investigate the best tourniquet strategy in TKA. The participants were randomly allocated to groups with different tourniquet strategies: Group 1) tourniquet inflation from skin to cement hardening (skin to cement); Group 2) tourniquet inflation only from cementation (cement only) and Group 3) tourniquet inflation from skin incision to skin closure (skin to skin). In addition to the blood loss and early postoperative outcomes, pain, soft tissue injury, and rehabilitation were also strictly monitored with a longer follow-up duration up to 6 months.

详细描述

A tourniquet is often used in total knee arthroplasty (TKA) to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation. On the other hand, the associated risks include skin burns, soft tissue and muscle damage, injury of calcified vessels, increased swelling and stiffness of the joints, nerve injury, paralysis, and thromboembolic events.

The automatic lower limb pneumatic tourniquet system (Zimmer) was applied to reduce blood loss during surgery. The skin under the tourniquet was covered by cast padding. The operated leg was elevated and exsanguinated before inflating the automatic pneumatic tourniquet. There are three main strategies for the use of a tourniquet in TKR: A) inflate before incision and deflate following cement hardening ('skin to cement'); B) inflate prior to cement application and deflated following hardening ('cement only'); C) inflate before incision and deflate following completion of skin closure ('skin to skin'). The optimal timing of tourniquet application during primary TKA is still a matter of debate. Most previous reports have failed to show significant differences among different tourniquet strategies.

Kvederas et al. compared these three strategies in a randomized double-blind clinical trial, and demonstrated that the estimated blood loss was highest when the tourniquet was inflated just before cement application and deflated after its hardening ('cement only'), while inflation of tourniquet before skin incision and its deflation after hardening of cement ('skin to cement') tends to give better early postoperative mobilization. However, this was an interim report with limited number of patients, and only limited outcome parameters were reported, which were insufficient to draw firm conclusions regarding the differences in outcome.

Therefore we performed this prospective randomized controlled trial (RCT) with a decent sample size to investigate the best tourniquet strategy in TKA. In addition to the blood loss and early postoperative outcomes, we also strictly monitored pain, soft tissue injury, and rehabilitation with a longer follow-up duration up to 6 months.

All of the operations were performed through the medial parapatellar approach by the same experienced joint replacement surgeon. All patients underwent primary TKA with minimally invasive techniques and cemented prostheses (EvolutionTM medial pivot, MicroPort, USA). An intramedullary guide was used for both tibial and femoral cuts.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, 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 suffer from primary osteoarthritis indicated for total knee arthroplasty
  • Subject is physically and mentally willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
  • Subject must have signed an informed consent document specific to the study, and approved by the Ethics Committee, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

排除标准

  • Subject requires a revision knee arthroplasty surgery
  • Subject is currently on anti-coagulant therapy or has coagulopathy
  • Subject has peripheral vascular disease of the lower limb evidenced by the presence of blood vessel calcification on the radiographs or the absence of dorsalis pedis/popliteal pulses
  • Subject suffers from conditions other than primary knee osteoarthritis, e.g. inflammatory arthritis
  • Subject having associated medical diseases affecting rehabilitation
  • Subject has active systemic infection or infection near the knee joint
  • Subject having current medical condition that render them unfit for surgery
  • Any criterion which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

结局指标

主要结局

Blood Loss

时间窗: 4 days after surgery

We calculated the intraoperative blood loss by measuring the suction volume and weighing the sponges. Hemoglobin (Hb) and hematocrit (Hct) levels were examined preoperatively, and on Day 1 to Day 4 after surgery. Change of Hb and Hct was calculated as the value of postoperative D1 to D4 minus preoperative value. The number of patients undergoing blood transfusion were recorded. The criterion for a blood transfusion was set as a Hb level of \<8 g/dL with symptomatic anemia. The calculated blood loss, which reflects actual blood loss, was determined with use of a previously described method. Briefly, the patients blood volume (PBV) is calculated using a formula, and multiplying the PBV by the change of haematocrit (preoperative value minus value on postoperative Day 2) will give the estimated total blood loss (ETBL).

次要结局

  • Soft-tissue damage(4 days after surgery)
  • Postoperative Visual Analog Scale(Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6)
  • 6-minute Walking Test(Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6)
  • Knee Society Function Score(Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6)
  • Time-up-and-go (TUG) Test(Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6)
  • Berg Balance Scale(Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6)
  • Thigh circumference(4 days after surgery)
  • Peak Quadriceps Strength(Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6)
  • Knee Society Knee Score(Day 1, Day 2, Day 3, Day 4, Day 7, Week 6, Month 3, and Month 6)

研究者

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

Dr. Yan Chun-Hoi

Clinical Associate Professor

The University of Hong Kong

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