Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Total Knee Arthroplasty, Knee Osteoarthritis

Intervention / Treatment
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* Procedure: bicruciate-retaining total knee arthroplasty
* Procedure: posterior-stabilized total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bicruciate-retaining total knee arthroplasty<br>The prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented. | Procedure: bicruciate-retaining total knee arthroplasty<br> <br> |
| Active Comparator: posterior-stabilized total knee arthroplasty<br>The prosthesis requires the excision of both cruciate ligaments | Procedure: posterior-stabilized total knee arthroplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in KOOS pain score | KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain score at 10 years after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in KOOS pain score | KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain score at 6 weeks after the surgery | 
| Change in KOOS pain score | KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain score at 6 months after the surgery | 
| Change in KOOS pain score | KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain score at 1 year after the surgery | 
| Change in KOOS pain score | KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain score at 2 years after the surgery | 
| Change in KOOS pain score | KOOS pain score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain score at 5 years after the surgery | 
| Change in KOOS symptoms score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain symptoms at 6 weeks after the surgery | 
| Change in KOOS symptoms score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS symptoms score at 6 months after the surgery | 
| Change in KOOS symptoms score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS symptoms score at 1 year after the surgery | 
| Change in KOOS symptoms score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS symptoms score at 2 years after the surgery | 
| Change in KOOS symptoms score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain symptoms at 5 years after the surgery | 
| Change in KOOS symptoms score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS pain symptoms at 10 years after the surgery | 
| Change in KOOS activity of daily living score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS activity of daily living at 6 weeks after the surgery | 
| Change in KOOS activity of daily living score | KOOS activity of daily living score; 0-100 scale, 0: extreme problems 100: no problems | 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 | KOOS activity of daily living score; 0-100 scale, 0: extreme problems 100: no problems | 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 | KOOS activity of daily living score; 0-100 scale, 0: extreme problems 100: no problems | 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 | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS activity of daily living at 5 years after the surgery | 
| Change in KOOS activity of daily living score | KOOS symptoms score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS activity of daily living at 10 years after the surgery | 
| Change in KOOS sport and recreation score | KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS sport and recreation at 6 weeks after the surgery | 
| Change in KOOS sport and recreation score | KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS sport and recreation score at 6 months after the surgery | 
| Change in KOOS sport and recreation score | KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS sport and recreation score at 1 year after the surgery | 
| Change in KOOS sport and recreation score | KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS sport and recreation score at 2 years after the surgery | 
| Change in KOOS sport and recreation score | KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS sport and recreation at 5 years after the surgery | 
| Change in KOOS sport and recreation score | KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS sport and recreation at 10 years after the surgery | 
| Change in KOOS quality of life score | KOOS quality of life score score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS quality of life at 6 weeks after the surgery | 
| Change in KOOS quality of life score | KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS quality of life score at 6 months after the surgery | 
| Change in KOOS quality of life score | KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS quality of life score at 1 year after the surgery | 
| Change in KOOS quality of life score | KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS quality of life score at 2 years after the surgery | 
| Change in KOOS quality of life score | KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS quality of life at 5 years after the surgery | 
| Change in KOOS quality of life score | KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems | Change from baseline (pre surgery) KOOS quality of life at 10 years after the surgery | 
| Change in MARX score | MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation | Change from baseline (pre surgery) MARX score at 6 weeks after the surgery | 
| Change in MARX score | MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation | Change from baseline (pre surgery) MARX score at 6 months after the surgery | 
| Change in MARX score | MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation | Change from baseline (pre surgery) MARX score at 1 year after the surgery | 
| Change in MARX score | MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation | Change from baseline (pre surgery) MARX score at 2 years after the surgery | 
| Change in MARX score | MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation | Change from baseline (pre surgery) MARX score at 5 yearss after the surgery | 
| Change in MARX score | MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation | Change from baseline (pre surgery) MARX score at 10 yearss after the surgery | 
| Change in International Knee Society scoring system (IKS) : knee score | IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee | Change from baseline (pre surgery) IKS Knee score at 6 weeks after the surgery | 
| Change in International Knee Society scoring system (IKS) : knee score | IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee | Change from baseline (pre surgery) IKS Knee score at 6 months after the surgery | 
| Change in International Knee Society scoring system (IKS) : knee score | IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee | Change from baseline (pre surgery) IKS Knee score at 1 year after the surgery | 
| Change in International Knee Society scoring system (IKS) : knee score | IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee | Change from baseline (pre surgery) IKS Knee score at 2 years after the surgery | 
| Change in International Knee Society scoring system (IKS) : knee score | IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee | Change from baseline (pre surgery) IKS Knee score at 5 years after the surgery | 
| Change in International Knee Society scoring system (IKS) : knee score | IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee | Change from baseline (pre surgery) IKS Knee score at 10 years after the surgery | 
| Change in International Knee Society scoring system (IKS) : function score | IKS Knee score; 0-100, 0: severe functional disability 100: no disability | Change from baseline (pre surgery) IKS function score at 6 weeks after the surgery | 
| Change in International Knee Society scoring system (IKS) : function score | IKS Knee score; 0-100, 0: severe functional disability 100: no disability | Change from baseline (pre surgery) IKS function score at 6 months after the surgery | 
| Change in International Knee Society scoring system (IKS) : function score | IKS Knee score; 0-100, 0: severe functional disability 100: no disability | Change from baseline (pre surgery) IKS function score at 1 year after the surgery | 
| Change in International Knee Society scoring system (IKS) : function score | IKS Knee score; 0-100, 0: severe functional disability 100: no disability | Change from baseline (pre surgery) IKS function score at 2 years after the surgery | 
| Change in International Knee Society scoring system (IKS) : function score | IKS Knee score; 0-100, 0: severe functional disability 100: no disability | Change from baseline (pre surgery) IKS function score at 5 years after the surgery | 
| Change in International Knee Society scoring system (IKS) : function score | IKS Knee score; 0-100, 0: severe functional disability 100: no disability | Change from baseline (pre surgery) IKS function score at 10 years after the surgery | 
| Change in Knee Range of Motion (ROM) | Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160 | Change from baseline (pre surgery) ROM at 6 weeks after the surgery | 
| Change in Knee Range of Motion (ROM) | Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160 | Change from baseline (pre surgery) ROM at 6 months after the surgery | 
| Change in Knee Range of Motion (ROM) | Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160 | Change from baseline (pre surgery) ROM at 1 year after the surgery | 
| Change in Knee Range of Motion (ROM) | Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160 | Change from baseline (pre surgery) ROM at 2 years after the surgery | 
| Change in Knee Range of Motion (ROM) | Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160 | Change from baseline (pre surgery) ROM at 5 years after the surgery | 
| Change in Knee Range of Motion (ROM) | Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160 | Change from baseline (pre surgery) ROM at 10 years after the surgery | 
| Change in Lower limb morphology in the coronal plane | Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees | 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 | Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees | 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 | Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees | 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 | Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees | 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 | Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees | Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 5 years after the surgery | 
| Change in Lower limb morphology in the coronal plane | Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees | Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 10 years after the surgery | 
| Change in Knee alignment : Hip-knee-ankle (HKA) | Hip-knee-ankle (HKA); 150-210 degrees | Change from baseline (pre surgery) HKA at 6 weeks after the surgery | 
| Change in Knee alignment : Hip-knee-ankle (HKA) | Hip-knee-ankle (HKA); 150-210 degrees | Change from baseline (pre surgery) HKA at 6 months after the surgery | 
| Change in Knee alignment : Hip-knee-ankle (HKA) | Hip-knee-ankle (HKA); 150-210 degrees | Change from baseline (pre surgery) HKA at 1 year after the surgery | 
| Change in Knee alignment : Hip-knee-ankle (HKA) | Hip-knee-ankle (HKA); 150-210 degrees | Change from baseline (pre surgery) HKA at 2 years after the surgery | 
| Change in Knee alignment : Hip-knee-ankle (HKA) | Hip-knee-ankle (HKA); 150-210 degrees | Change from baseline (pre surgery) HKA at 5 years after the surgery | 
| Change in Knee alignment : Hip-knee-ankle (HKA) | Hip-knee-ankle (HKA); 150-210 degrees | Change from baseline (pre surgery) HKA at 10 years after the surgery | 
| Change in Knee alignment : Hip-knee-shaft (HKS) | Hip-knee-shaft (HKS); 2-15 degrees | Change from baseline (pre surgery) HKS at 6 weeks after the surgery | 
| Change in Knee alignment : Hip-knee-shaft (HKS) | Hip-knee-shaft (HKS); 2-15 degrees | Change from baseline (pre surgery) HKS at 6 months after the surgery | 
| Change in Knee alignment : Hip-knee-shaft (HKS) | Hip-knee-shaft (HKS); 2-15 degrees | Change from baseline (pre surgery) HKS at 1 year after the surgery | 
| Change in Knee alignment : Hip-knee-shaft (HKS) | Hip-knee-shaft (HKS); 2-15 degrees | Change from baseline (pre surgery) HKS at 2 years after the surgery | 
| Change in Knee alignment : Hip-knee-shaft (HKS) | Hip-knee-shaft (HKS); 2-15 degrees | Change from baseline (pre surgery) HKS at 5 years after the surgery | 
| Change in Knee alignment : Hip-knee-shaft (HKS) | Hip-knee-shaft (HKS); 2-15 degrees | Change from baseline (pre surgery) HKS at 10 years after the surgery | 
| Change in Knee alignment : Medial distal femoral angle (MDFA) | Medial distal femoral angle (MDFA); 75-100 degrees | Change from baseline (pre surgery) MDFA at 6 weeks after the surgery | 
| Change in Knee alignment : Medial distal femoral angle (MDFA) | Medial distal femoral angle (MDFA); 75-100 degrees | Change from baseline (pre surgery) MDFA at 6 months after the surgery | 
| Change in Knee alignment : Medial distal femoral angle (MDFA) | Medial distal femoral angle (MDFA); 75-100 degrees | Change from baseline (pre surgery) MDFA at 1 year after the surgery | 
| Change in Knee alignment : Medial distal femoral angle (MDFA) | Medial distal femoral angle (MDFA); 75-100 degrees | Change from baseline (pre surgery) MDFA at 2 years after the surgery | 
| Change in Knee alignment : Medial distal femoral angle (MDFA) | Medial distal femoral angle (MDFA); 75-100 degrees | Change from baseline (pre surgery) MDFA at 5 years after the surgery | 
| Change in Knee alignment : Medial distal femoral angle (MDFA) | Medial distal femoral angle (MDFA); 75-100 degrees | Change from baseline (pre surgery) MDFA at 10 years after the surgery | 
| Change in Knee alignment : Medial proximal tibial angle (MPTA) | Medial proximal tibial angle (MPTA); 70-110 degrees | Change from baseline (pre surgery) MPTA at 6 weeks after the surgery | 
| Change in Knee alignment : Medial proximal tibial angle (MPTA) | Medial proximal tibial angle (MPTA); 70-110 degrees | Change from baseline (pre surgery) MPTA at 6 months after the surgery | 
| Change in Knee alignment : Medial proximal tibial angle (MPTA) | Medial proximal tibial angle (MPTA); 70-110 degrees | Change from baseline (pre surgery) MPTA at 1 year after the surgery | 
| Change in Knee alignment : Medial proximal tibial angle (MPTA) | Medial proximal tibial angle (MPTA); 70-110 degrees | Change from baseline (pre surgery) MPTA at 2 years after the surgery | 
| Change in Knee alignment : Medial proximal tibial angle (MPTA) | Medial proximal tibial angle (MPTA); 70-110 degrees | Change from baseline (pre surgery) MPTA at 5 years after the surgery | 
| Change in Knee alignment : Medial proximal tibial angle (MPTA) | Medial proximal tibial angle (MPTA); 70-110 degrees | Change from baseline (pre surgery) MPTA at 10 years after the surgery | 
| Change in Knee ligament laxity : Anterior/Posterior Instability | Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm | Change from baseline (pre surgery) Anterior/Posterior Instability at 6 weeks after the surgery | 
| Change in Knee ligament laxity : Anterior/Posterior Instability | Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm | Change from baseline (pre surgery) Anterior/Posterior Instability at 6 months after the surgery | 
| Change in Knee ligament laxity : Anterior/Posterior Instability | Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm | Change from baseline (pre surgery) Anterior/Posterior Instability at 1 year after the surgery | 
| Change in Knee ligament laxity : Anterior/Posterior Instability | Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm | Change from baseline (pre surgery) Anterior/Posterior Instability at 2 years after the surgery | 
| Change in Knee ligament laxity : Anterior/Posterior Instability | Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm | Change from baseline (pre surgery) Anterior/Posterior Instability at 5 years after the surgery | 
| Change in Knee ligament laxity : Anterior/Posterior Instability | Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm | Change from baseline (pre surgery) Anterior/Posterior Instability at 10 years after the surgery | 
| Change in Knee ligament laxity : Medial/Lateral Instability | Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm | Change from baseline (pre surgery) Medial/Lateral Instability at 6 weeks after the surgery | 
| Change in Knee ligament laxity : Medial/Lateral Instability | Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm | Change from baseline (pre surgery) Medial/Lateral Instability at 6 months after the surgery | 
| Change in Knee ligament laxity : Medial/Lateral Instability | Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm | Change from baseline (pre surgery) Medial/Lateral Instability at 1 year after the surgery | 
| Change in Knee ligament laxity : Medial/Lateral Instability | Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm | Change from baseline (pre surgery) Medial/Lateral Instability at 2 years after the surgery | 
| Change in Knee ligament laxity : Medial/Lateral Instability | Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm | Change from baseline (pre surgery) Medial/Lateral Instability at 5 years after the surgery | 
| Change in Knee ligament laxity : Medial/Lateral Instability | Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm | Change from baseline (pre surgery) Medial/Lateral Instability at 10 years after the surgery | 
| Change in Patellar apprehension test | Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation | Change from baseline (pre surgery) Patellofemoral Instability at 6 weeks after the surgery | 
| Change in Patellar apprehension test | Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation | Change from baseline (pre surgery) Patellofemoral Instability at 6 months after the surgery | 
| Change in Patellar apprehension test | Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation | Change from baseline (pre surgery) Patellofemoral Instability at 1 year after the surgery | 
| Change in Patellar apprehension test | Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation | Change from baseline (pre surgery) Patellofemoral Instability at 2 years after the surgery | 
| Change in Patellar apprehension test | Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation | Change from baseline (pre surgery) Patellofemoral Instability at 5 years after the surgery | 
| Change in Patellar apprehension test | Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation | Change from baseline (pre surgery) Patellofemoral Instability at 10 years after the surgery | 
| Change in Physical Activity Level Scale | Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive | Change from baseline (pre surgery) Physical Activity Level at 6 weeks after the surgery | 
| Change in Physical Activity Level Scale | Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive | Change from baseline (pre surgery) Physical Activity Level at 6 months after the surgery | 
| Change in Physical Activity Level Scale | Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive | Change from baseline (pre surgery) Physical Activity Level at 1 year after the surgery | 
| Change in Physical Activity Level Scale | Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive | Change from baseline (pre surgery) Physical Activity Level at 2 years after the surgery | 
| Change in Physical Activity Level Scale | Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive | Change from baseline (pre surgery) Physical Activity Level at 5 years after the surgery | 
| Change in Physical Activity Level Scale | Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive | Change from baseline (pre surgery) Physical Activity Level at 10 years after the surgery | 
| Change in Physical Activities Scale | Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot | Change from baseline (pre surgery) Physical Activities at 6 weeks after the surgery | 
| Change in Physical Activities Scale | Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot | Change from baseline (pre surgery) Physical Activities at 6 months after the surgery | 
| Change in Physical Activities Scale | Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot | Change from baseline (pre surgery) Physical Activities at 1 year after the surgery | 
| Change in Physical Activities Scale | Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot | Change from baseline (pre surgery) Physical Activities at 2 years after the surgery | 
| Change in Physical Activities Scale | Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot | Change from baseline (pre surgery) Physical Activities at 5 years after the surgery | 
| Change in Physical Activities Scale | Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot | Change from baseline (pre surgery) Physical Activities at 10 years after the surgery | 
| Change in 12-Item Short Form Survey (SF-12) score | SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. | Change from baseline (pre surgery) SF-12 Questionnaire at 6 weeks after the surgery | 
| Change in 12-Item Short Form Survey (SF-12) score | SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. | Change from baseline (pre surgery) SF-12 Questionnaire at 6 months after the surgery | 
| Change in 12-Item Short Form Survey (SF-12) score | SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. | Change from baseline (pre surgery) SF-12 Questionnaire at 1 year after the surgery | 
| Change in 12-Item Short Form Survey (SF-12) score | SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. | Change from baseline (pre surgery) SF-12 Questionnaire at 2 years after the surgery | 
| Change in 12-Item Short Form Survey (SF-12) score | SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. | Change from baseline (pre surgery) SF-12 Questionnaire at 5 years after the surgery | 
| Change in 12-Item Short Form Survey (SF-12) score | SF-12; Physical component summary (PCS-12), Mental component summary (MCS-12), the scores are reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. | Change from baseline (pre surgery) SF-12 Questionnaire at 10 years after the surgery | 
| Change in TELOS radiological laximetry | TELOS radiological laximetry of both knees; varus and valgus laxity with knees in extension, anterior-posterior laxity of the knees at 20 and 90 degrees of flexion | 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 | EOS imaging of both knees during a standardized squatting task; knee rotation around the media-lateral axis (knee flexion and extension), degrees | 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 | EOS imaging of both knees during a standardized squatting task; knee rotation around the anteroposterior axis (knee abduction and adduction), degrees | 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 internal and external rotation | EOS imaging of both knees during a standardized squatting task; knee rotation around the longitudinal axis (knee internal and external rotation), degrees | 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 | EOS imaging of both knees during a free squatting task; knee rotation around the media-lateral axis (knee flexion and extension), degrees | 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 | EOS imaging of both knees during a free squatting task; knee rotation around the anteroposterior axis (knee abduction and adduction), degrees | 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 | EOS imaging of both knees during a free squatting task; knee rotation around the longitudinal axis (knee internal and external rotation), degrees | 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 | 3D kinematics assessment during walking, the knee kinematics will be assessed using the kneeKG system, knee rotation around the media-lateral axis (knee flexion and extension), degrees | Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery | 
| Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee abduction and adduction | 3D kinematics assessment during walking, the knee kinematics will be assessed using the kneeKG system, knee rotation around the anteroposterior axis (knee abduction and adduction), degrees | Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery | 
| Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee internal and external rotation | 3D kinematics assessment during walking, the knee kinematics will be assessed using the kneeKG system, knee rotation around the longitudinal axis (knee internal and external rotation), degrees | Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kinematic, bicruciate-retaining, posterior-stabilized, Total Knee Arthroplasty, Knee Osteoarthritis