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临床试验/NCT05469776
NCT05469776进行中（未招募）不适用

Retention of Both Cruciate Ligaments During Total Knee Arthroplasty: a Prospective Randomized Study

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2011年1月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
77
试验地点
1
主要终点
Change in KOOS pain score
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Total knee arthroplasty (TKA) with the sacrifice of the anterior cruciate ligament is the standard treatment for severe knee osteoarthritis. A number of studies on the kinematics of the prosthetic knee tend to show that implants that preserve the cruciate ligaments best reproduce the kinematics of the healthy knee. The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used. It is anticipated that the bicruciate-retaining prosthesis will result in better function of the operated knee than the posterior-stabilized prosthesis.

Method:

  • Randomized controlled trial
  • Monocentric
  • Randomization will be done using sealed envelopes

详细描述

Posterior cruciate ligament replacement knee prostheses or posterior-stabilized (PS) are the most used type of prosthesis. Various studies of the kinematics of the prosthetic knee tend to show that implants that preserve both cruciate ligaments best reproduce the kinematics of the healthy knee. These implants are the unicondylar knee Arthroplasty - in which only one side of the femorotibial joint is replaced; most often the medial side - and the bicruciate-retaining total knee arthroplasty (BCR). The BCR prosthesis is perceived as technically difficult to install and has never been a great commercial success despite the scientific demonstration of its virtues for knee kinematics. Given the current trend among prosthetic implant manufacturers to optimize the performance of knee prostheses for younger, active patients, the retention of both cruciate ligaments appears to be an interesting alternative. Unfortunately, there are no good studies comparing the results of the BCR prosthesis to the PS prosthesis.

The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used (BCR vs PS).

The hypothesis is that the BCR prosthesis will result in better function of the operated knee than the PS prosthesis, resulting in joint kinematics closer to a healthy knee, better clinical scores and a higher activity level.

60 patients undergoing a total knee arthroplasty will be recruited. Randomization will be done intraoperatively using sealed envelopes once the indication for BCR TKA has been definitively established. Demographic data, medical history, clinical assessment and 4 questionnaires (IKS, KOOS, Marx and SF-12) will be completed prior to surgery. A standard x-ray, EOS imaging, TELOS radiological laximetry and a non-invasive evaluation of the 3D kinematics will be performed before the surgery.

Patients will complete the 4 questionnaires at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post-surgery. A standard radiological examination will be performed at the same follow-ups. TELOS radiological laximetry, EOS imaging and 3D kinematics assessment will be repeated at the 1-year follow-up post-surgery.

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 (Participant)

入排标准

年龄范围
18 Years 至 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients awaiting a total knee replacement who are candidates for a bi-cruciate retaining prosthesis
  • •Disabling bicompartmental gonarthrosis with failure of conservative treatment
  • •70 years of age or younger at the time of the pre-operative consultation
  • •Intact and functional cruciate ligaments
  • •Coronal knee malalignment of 10 degrees or less
  • •Adequate preoperative range of motion, defined as maximum flexum (inability to fully extend the knee) of 10 degrees and flexion greater than 90 degrees
  • •Adequate intraoperative knee exposure to allow preservation of both cruciate ligaments

排除标准

  • •Inability to undergo an EOS examination, defined as the inability to stand or morbid obesity (inability of the patient to enter the EOS machine, which is relatively cramped)
  • •Inability to walk on a treadmill and squat
  • •Pregnant women to avoid unnecessary fetal radiation
  • •Illiteracy, language barrier and any other reason that prevents patients from answering the questionnaires

研究组 & 干预措施

bicruciate-retaining total knee arthroplasty

Experimental

The prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented.

干预措施: bicruciate-retaining total knee arthroplasty (Procedure)

posterior-stabilized total knee arthroplasty

Active Comparator

The prosthesis requires the excision of both cruciate ligaments

干预措施: posterior-stabilized total knee arthroplasty (Procedure)

结局指标

主要结局

Change in KOOS pain score

时间窗: Change from baseline (pre surgery) KOOS pain score at 10 years after the surgery

KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems

次要结局

  • Change in Knee alignment : Medial distal femoral angle (MDFA)(Change from baseline (pre surgery) MDFA at 10 years after the surgery)
  • Change in KOOS sport and recreation score(Change from baseline (pre surgery) KOOS sport and recreation at 10 years after the surgery)
  • Change in International Knee Society scoring system (IKS) : knee score(Change from baseline (pre surgery) IKS Knee score at 10 years after the surgery)
  • Change in Knee ligament laxity : Anterior/Posterior Instability(Change from baseline (pre surgery) Anterior/Posterior Instability at 10 years after the surgery)
  • Change in KOOS activity of daily living score(Change from baseline (pre surgery) KOOS activity of daily living at 10 years after the surgery)
  • Change in KOOS quality of life score(Change from baseline (pre surgery) KOOS quality of life at 10 years after the surgery)
  • Change in Knee Range of Motion (ROM)(Change from baseline (pre surgery) ROM at 10 years after the surgery)
  • Change in Knee alignment : Hip-knee-ankle (HKA)(Change from baseline (pre surgery) HKA at 10 years after the surgery)
  • Change in Patellar apprehension test(Change from baseline (pre surgery) Patellofemoral Instability at 10 years after the surgery)
  • Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee internal and external rotation(Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery)
  • Change in KOOS pain score(Change from baseline (pre surgery) KOOS pain score at 5 years after the surgery)
  • Change in International Knee Society scoring system (IKS) : function score(Change from baseline (pre surgery) IKS function score at 10 years after the surgery)
  • Change in Lower limb morphology in the coronal plane(Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 10 years after the surgery)
  • Change in Knee alignment : Medial proximal tibial angle (MPTA)(Change from baseline (pre surgery) MPTA at 10 years after the surgery)
  • Change in KOOS symptoms score(Change from baseline (pre surgery) KOOS pain symptoms at 10 years after the surgery)
  • Change in MARX score(Change from baseline (pre surgery) MARX score at 10 yearss after the surgery)
  • Change in Knee alignment : Hip-knee-shaft (HKS)(Change from baseline (pre surgery) HKS at 10 years after the surgery)
  • Change in 12-Item Short Form Survey (SF-12) score(Change from baseline (pre surgery) SF-12 Questionnaire at 10 years after the surgery)
  • Change in Knee ligament laxity : Medial/Lateral Instability(Change from baseline (pre surgery) Medial/Lateral Instability at 10 years after the surgery)
  • Change in TELOS radiological laximetry(Change from baseline (pre surgery) TELOS radiological laximetry at 1 year after the surgery)
  • Change in EOS imaging pseudo-kinematic - standardized squatting task - knee flexion and extension(Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery)
  • Change in EOS imaging pseudo-kinematic - standardized squatting task - knee abduction and adduction(Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery)
  • Change in EOS imaging pseudo-kinematic - free squatting task - knee flexion and extension(Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery)
  • Change in EOS imaging pseudo-kinematic - free squatting task - knee abduction and adduction(Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery)
  • Change in EOS imaging pseudo-kinematic - free squatting task - knee internal and external rotation(Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery)
  • Changes in 3D knee kinematics assessment during walking - knee flexion and extension(Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery)
  • Change in Physical Activity Level Scale(Change from baseline (pre surgery) Physical Activity Level at 10 years after the surgery)
  • Change in Physical Activities Scale(Change from baseline (pre surgery) Physical Activities at 10 years after the surgery)
  • Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee abduction and adduction(Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery)
  • Change in EOS imaging pseudo-kinematic - standardized squatting task - knee internal and external rotation(Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery)
  • Change in KOOS pain score(Change from baseline (pre surgery) KOOS pain score at 6 weeks after the surgery)
  • Change in KOOS pain score(Change from baseline (pre surgery) KOOS pain score at 6 months after the surgery)
  • Change in KOOS pain score(Change from baseline (pre surgery) KOOS pain score at 1 year after the surgery)
  • Change in KOOS pain score(Change from baseline (pre surgery) KOOS pain score at 2 years after the surgery)
  • Change in KOOS symptoms score(Change from baseline (pre surgery) KOOS pain symptoms at 6 weeks after the surgery)
  • Change in KOOS symptoms score(Change from baseline (pre surgery) KOOS symptoms score at 6 months after the surgery)
  • Change in KOOS symptoms score(Change from baseline (pre surgery) KOOS symptoms score at 1 year after the surgery)
  • Change in KOOS symptoms score(Change from baseline (pre surgery) KOOS symptoms score at 2 years after the surgery)
  • Change in KOOS symptoms score(Change from baseline (pre surgery) KOOS pain symptoms at 5 years after the surgery)
  • Change in KOOS activity of daily living score(Change from baseline (pre surgery) KOOS activity of daily living at 6 weeks after the surgery)
  • Change in KOOS activity of daily living score(Change from baseline (pre surgery) KOOS activity of daily living score at 6 months after the surgery)
  • Change in KOOS activity of daily living score(Change from baseline (pre surgery) KOOS activity of daily living score at 1 year after the surgery)
  • Change in KOOS activity of daily living score(Change from baseline (pre surgery) KOOS activity of daily living score at 2 years after the surgery)
  • Change in KOOS activity of daily living score(Change from baseline (pre surgery) KOOS activity of daily living at 5 years after the surgery)
  • Change in KOOS sport and recreation score(Change from baseline (pre surgery) KOOS sport and recreation at 6 weeks after the surgery)
  • Change in KOOS sport and recreation score(Change from baseline (pre surgery) KOOS sport and recreation score at 6 months after the surgery)
  • Change in KOOS sport and recreation score(Change from baseline (pre surgery) KOOS sport and recreation score at 1 year after the surgery)
  • Change in KOOS sport and recreation score(Change from baseline (pre surgery) KOOS sport and recreation score at 2 years after the surgery)
  • Change in KOOS sport and recreation score(Change from baseline (pre surgery) KOOS sport and recreation at 5 years after the surgery)
  • Change in KOOS quality of life score(Change from baseline (pre surgery) KOOS quality of life at 6 weeks after the surgery)
  • Change in KOOS quality of life score(Change from baseline (pre surgery) KOOS quality of life score at 6 months after the surgery)
  • Change in KOOS quality of life score(Change from baseline (pre surgery) KOOS quality of life score at 1 year after the surgery)
  • Change in KOOS quality of life score(Change from baseline (pre surgery) KOOS quality of life score at 2 years after the surgery)
  • Change in KOOS quality of life score(Change from baseline (pre surgery) KOOS quality of life at 5 years after the surgery)
  • Change in MARX score(Change from baseline (pre surgery) MARX score at 6 weeks after the surgery)
  • Change in MARX score(Change from baseline (pre surgery) MARX score at 6 months after the surgery)
  • Change in MARX score(Change from baseline (pre surgery) MARX score at 1 year after the surgery)
  • Change in MARX score(Change from baseline (pre surgery) MARX score at 2 years after the surgery)
  • Change in MARX score(Change from baseline (pre surgery) MARX score at 5 yearss after the surgery)
  • Change in International Knee Society scoring system (IKS) : knee score(Change from baseline (pre surgery) IKS Knee score at 6 weeks after the surgery)
  • Change in International Knee Society scoring system (IKS) : knee score(Change from baseline (pre surgery) IKS Knee score at 6 months after the surgery)
  • Change in International Knee Society scoring system (IKS) : knee score(Change from baseline (pre surgery) IKS Knee score at 1 year after the surgery)
  • Change in International Knee Society scoring system (IKS) : knee score(Change from baseline (pre surgery) IKS Knee score at 2 years after the surgery)
  • Change in International Knee Society scoring system (IKS) : knee score(Change from baseline (pre surgery) IKS Knee score at 5 years after the surgery)
  • Change in International Knee Society scoring system (IKS) : function score(Change from baseline (pre surgery) IKS function score at 6 weeks after the surgery)
  • Change in International Knee Society scoring system (IKS) : function score(Change from baseline (pre surgery) IKS function score at 6 months after the surgery)
  • Change in International Knee Society scoring system (IKS) : function score(Change from baseline (pre surgery) IKS function score at 1 year after the surgery)
  • Change in International Knee Society scoring system (IKS) : function score(Change from baseline (pre surgery) IKS function score at 2 years after the surgery)
  • Change in International Knee Society scoring system (IKS) : function score(Change from baseline (pre surgery) IKS function score at 5 years after the surgery)
  • Change in Knee Range of Motion (ROM)(Change from baseline (pre surgery) ROM at 6 weeks after the surgery)
  • Change in Knee Range of Motion (ROM)(Change from baseline (pre surgery) ROM at 6 months after the surgery)
  • Change in Knee Range of Motion (ROM)(Change from baseline (pre surgery) ROM at 1 year after the surgery)
  • Change in Knee Range of Motion (ROM)(Change from baseline (pre surgery) ROM at 2 years after the surgery)
  • Change in Knee Range of Motion (ROM)(Change from baseline (pre surgery) ROM at 5 years after the surgery)
  • Change in Lower limb morphology in the coronal plane(Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 6 weeks after the surgery)
  • Change in Lower limb morphology in the coronal plane(Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 6 months after the surgery)
  • Change in Lower limb morphology in the coronal plane(Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 1 year after the surgery)
  • Change in Lower limb morphology in the coronal plane(Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 2 years after the surgery)
  • Change in Lower limb morphology in the coronal plane(Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 5 years after the surgery)
  • Change in Knee alignment : Hip-knee-ankle (HKA)(Change from baseline (pre surgery) HKA at 6 weeks after the surgery)
  • Change in Knee alignment : Hip-knee-ankle (HKA)(Change from baseline (pre surgery) HKA at 6 months after the surgery)
  • Change in Knee alignment : Hip-knee-ankle (HKA)(Change from baseline (pre surgery) HKA at 1 year after the surgery)
  • Change in Knee alignment : Hip-knee-ankle (HKA)(Change from baseline (pre surgery) HKA at 2 years after the surgery)
  • Change in Knee alignment : Hip-knee-ankle (HKA)(Change from baseline (pre surgery) HKA at 5 years after the surgery)
  • Change in Knee alignment : Hip-knee-shaft (HKS)(Change from baseline (pre surgery) HKS at 6 weeks after the surgery)
  • Change in Knee alignment : Hip-knee-shaft (HKS)(Change from baseline (pre surgery) HKS at 6 months after the surgery)
  • Change in Knee alignment : Hip-knee-shaft (HKS)(Change from baseline (pre surgery) HKS at 1 year after the surgery)
  • Change in Knee alignment : Hip-knee-shaft (HKS)(Change from baseline (pre surgery) HKS at 2 years after the surgery)
  • Change in Knee alignment : Hip-knee-shaft (HKS)(Change from baseline (pre surgery) HKS at 5 years after the surgery)
  • Change in Knee alignment : Medial distal femoral angle (MDFA)(Change from baseline (pre surgery) MDFA at 6 weeks after the surgery)
  • Change in Knee alignment : Medial distal femoral angle (MDFA)(Change from baseline (pre surgery) MDFA at 6 months after the surgery)
  • Change in Knee alignment : Medial distal femoral angle (MDFA)(Change from baseline (pre surgery) MDFA at 1 year after the surgery)
  • Change in Knee alignment : Medial distal femoral angle (MDFA)(Change from baseline (pre surgery) MDFA at 2 years after the surgery)
  • Change in Knee alignment : Medial distal femoral angle (MDFA)(Change from baseline (pre surgery) MDFA at 5 years after the surgery)
  • Change in Knee alignment : Medial proximal tibial angle (MPTA)(Change from baseline (pre surgery) MPTA at 6 weeks after the surgery)
  • Change in Knee alignment : Medial proximal tibial angle (MPTA)(Change from baseline (pre surgery) MPTA at 6 months after the surgery)
  • Change in Knee alignment : Medial proximal tibial angle (MPTA)(Change from baseline (pre surgery) MPTA at 1 year after the surgery)
  • Change in Knee alignment : Medial proximal tibial angle (MPTA)(Change from baseline (pre surgery) MPTA at 2 years after the surgery)
  • Change in Knee alignment : Medial proximal tibial angle (MPTA)(Change from baseline (pre surgery) MPTA at 5 years after the surgery)
  • Change in Knee ligament laxity : Anterior/Posterior Instability(Change from baseline (pre surgery) Anterior/Posterior Instability at 6 weeks after the surgery)
  • Change in Knee ligament laxity : Anterior/Posterior Instability(Change from baseline (pre surgery) Anterior/Posterior Instability at 6 months after the surgery)
  • Change in Knee ligament laxity : Anterior/Posterior Instability(Change from baseline (pre surgery) Anterior/Posterior Instability at 1 year after the surgery)
  • Change in Knee ligament laxity : Anterior/Posterior Instability(Change from baseline (pre surgery) Anterior/Posterior Instability at 2 years after the surgery)
  • Change in Knee ligament laxity : Anterior/Posterior Instability(Change from baseline (pre surgery) Anterior/Posterior Instability at 5 years after the surgery)
  • Change in Knee ligament laxity : Medial/Lateral Instability(Change from baseline (pre surgery) Medial/Lateral Instability at 6 weeks after the surgery)
  • Change in Knee ligament laxity : Medial/Lateral Instability(Change from baseline (pre surgery) Medial/Lateral Instability at 6 months after the surgery)
  • Change in Knee ligament laxity : Medial/Lateral Instability(Change from baseline (pre surgery) Medial/Lateral Instability at 1 year after the surgery)
  • Change in Knee ligament laxity : Medial/Lateral Instability(Change from baseline (pre surgery) Medial/Lateral Instability at 2 years after the surgery)
  • Change in Knee ligament laxity : Medial/Lateral Instability(Change from baseline (pre surgery) Medial/Lateral Instability at 5 years after the surgery)
  • Change in Patellar apprehension test(Change from baseline (pre surgery) Patellofemoral Instability at 6 weeks after the surgery)
  • Change in Patellar apprehension test(Change from baseline (pre surgery) Patellofemoral Instability at 6 months after the surgery)
  • Change in Patellar apprehension test(Change from baseline (pre surgery) Patellofemoral Instability at 1 year after the surgery)
  • Change in Patellar apprehension test(Change from baseline (pre surgery) Patellofemoral Instability at 2 years after the surgery)
  • Change in Patellar apprehension test(Change from baseline (pre surgery) Patellofemoral Instability at 5 years after the surgery)
  • Change in Physical Activity Level Scale(Change from baseline (pre surgery) Physical Activity Level at 6 weeks after the surgery)
  • Change in Physical Activity Level Scale(Change from baseline (pre surgery) Physical Activity Level at 6 months after the surgery)
  • Change in Physical Activity Level Scale(Change from baseline (pre surgery) Physical Activity Level at 1 year after the surgery)
  • Change in Physical Activity Level Scale(Change from baseline (pre surgery) Physical Activity Level at 2 years after the surgery)
  • Change in Physical Activity Level Scale(Change from baseline (pre surgery) Physical Activity Level at 5 years after the surgery)
  • Change in Physical Activities Scale(Change from baseline (pre surgery) Physical Activities at 6 weeks after the surgery)
  • Change in Physical Activities Scale(Change from baseline (pre surgery) Physical Activities at 6 months after the surgery)
  • Change in Physical Activities Scale(Change from baseline (pre surgery) Physical Activities at 1 year after the surgery)
  • Change in Physical Activities Scale(Change from baseline (pre surgery) Physical Activities at 2 years after the surgery)
  • Change in Physical Activities Scale(Change from baseline (pre surgery) Physical Activities at 5 years after the surgery)
  • Change in 12-Item Short Form Survey (SF-12) score(Change from baseline (pre surgery) SF-12 Questionnaire at 6 weeks after the surgery)
  • Change in 12-Item Short Form Survey (SF-12) score(Change from baseline (pre surgery) SF-12 Questionnaire at 6 months after the surgery)
  • Change in 12-Item Short Form Survey (SF-12) score(Change from baseline (pre surgery) SF-12 Questionnaire at 1 year after the surgery)
  • Change in 12-Item Short Form Survey (SF-12) score(Change from baseline (pre surgery) SF-12 Questionnaire at 2 years after the surgery)
  • Change in 12-Item Short Form Survey (SF-12) score(Change from baseline (pre surgery) SF-12 Questionnaire at 5 years after the surgery)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frédéric Lavoie

Orthopedic surgeon

Centre hospitalier de l'Université de Montréal (CHUM)

研究点 (1)

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