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临床试验/NCT03081663
NCT03081663已完成不适用

Cost and Patient Satisfaction After Total Knee Arthroplasty: Standard Medial Para-patellar Versus Quadriceps Sparing Mid-vastus Surgical Approach

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2017年7月11日最近更新:
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
83
试验地点
1
主要终点
Indirect and Direct Costs of Treatment

研究概览

简要总结

This study is a randomized clinical trial comparing standard medial para-patellar total knee arthroplasty with a quadriceps sparing mid-vastus approach. Patients who are medically well and have a good support structure at home will be randomized to a standard or quadriceps sparing surgical approach stratified by type of analgesia (adductor canal block or local infiltration). We will compare patient satisfaction and costs from the perspective of the Ministry of Health, the institution, society and the patient.

详细描述

Over the past 20 years the length of stay in hospital after total knee replacements has decreased from 9 days to 3 days in Canada and in just the last 10 years the mean length of stay has decreased by half from 6 to 3 days. In order to discharge patients quicker from hospital it's been theorized that less invasive techniques and better, longer lasting anaesthesia are required.

The less invasive quadriceps sparing mid-vastus approach for TKA has been compared to the standard medial para-patellar technique in many studies. Meta-analyses that have looked at studies comparing these approaches have shown some early advantages for quadriceps sparing early post-surgery, but no differences between groups later on and no difference in complications. Early advantages of the mid-vastus approach could potentially allow for earlier and safer discharge from hospital.

Adductor canal block (ACB) and local infiltration analgesia (LIA) form the mainstay of opioid sparing multimodal analgesia for TKA. The nerves of the adductor canal innervate the superficial and deep tissues of the anterior and medial aspects of the knee. ACB has been shown to provide equivalent analgesia while maintaining quadriceps power compared to femoral nerve block (FNB). LIA involves infiltrating the soft tissues of the posterior, lateral and medial aspects of the knee with local anesthetics, ketorolac and morphine. Due to their minimal impact on motor function, ACB and LIA are suitable for fast track TKA.

In combination, quadriceps sparing mid-vastus TKA with ACB may allow patients to be discharged from hospital quicker when compared with standard medial para-patellar TKA with LIA. With our study we aim to investigate whether a quadriceps sparing TKA can provide cost savings without changing complication rates when compared to the current standard of care.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not be told which group they have been assigned to until they have reached the final follow-up visit for the study.

入排标准

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

入选标准

  • •patients requiring primary total knee replacement
  • •patients willing and able to comply with follow-up requirements and self-evaluations
  • •patients willing to sign an IRB approved informed consent form
  • •English fluency (printed instructions are provided in English only)
  • •varus arthropathy
  • •osteoarthritis
  • •ASA less than or equal to 3
  • •home/cell phone access
  • •adult to accompany patient home post-operatively and to stay with patient for a minimum period of 1-2 days

排除标准

  • •patients with inflammatory arthritis
  • •patients with a BMI greater than 40 or less than 18
  • •patients who are skeletally immature
  • •patient with an active infection or suspected latent infection in or about the joint
  • •bone stock that is inadequate for support or fixation of the prosthesis
  • •hardware precluding intramedullary instrumentation
  • •prior osteotomies of the femur or tibia
  • •patients living greater than 1.5 hours from the hospital
  • •patients without access to caregivers, or unable to go to their home after surgery
  • •cognitive or neuromotor conditions
  • •patient has significant pain management issues
  • •patient/family history of anaesthesia related complications (e.g. malignant hypothermia, pseudocholinesterase deficiency, airway difficulties, obstructive sleep apnea)
  • •significant psycho/social issues that would prevent the patient from managing at home safely

研究组 & 干预措施

Quads-Sparing Approach with Tourniquet

Experimental

Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet.

干预措施: Quads-Sparing Approach (Procedure)

Medial Para-Patellar with Tourniquet

Active Comparator

Participants will undergo total knee arthroplasty with a medial para-patellar approach and a tourniquet. An intramedullary femoral guide and extramedullary tibial guide will be used during the surgery.

干预措施: Medial Para-Patellar Approach (Procedure)

Quads-Sparing Approach w/o Tourniquet

Active Comparator

Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet.

干预措施: Quads-Sparing Approach (Procedure)

Medial Para-Patellar w/o Tourniquet

Active Comparator

Participants will undergo total knee arthroplasty with a medial para-patellar approach and no tourniquet. An intramedullary femoral guide and extramedullary tibial guide will be used during the surgery.

干预措施: Medial Para-Patellar Approach (Procedure)

结局指标

主要结局

Indirect and Direct Costs of Treatment

时间窗: 1 year

ER visits, clinician visits, caregiver lost productivity, tests, etc.

次要结局

  • Pain Numeric Rating Scale(1 year)
  • Adverse events(1 year)
  • Western Ontario McMaster Osteoarthritis Index (WOMAC)(1 year)
  • Patient Satisfaction Questionnaire(2 weeks)
  • Short Form - 12 (SF-12)(1 year)
  • Knee Society Score (KSS)(1 year)
  • EuroQol-5D (EQ-5D)(1 year)
  • Timed Up and Go Test(1 year)
  • Caregiver Strain Index(6 weeks)
  • Caregiver Assistance Scale(6 weeks)

研究者

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

Brent Lanting

Orthopaedic Surgeon

Lawson Health Research Institute

研究点 (1)

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