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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty
• Intervention / Treatment: Procedure: bicruciate-retaining total knee arthroplasty; Procedure: posterior-stabilized total knee arthroplasty

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Mass Index (BMI)	BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity	Change from baseline (pre surgery) BMI at 6 weeks after the surgery
Change in Body Mass Index (BMI)	BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity	Change from baseline (pre surgery) BMI at 6 months after the surgery
Change in Body Mass Index (BMI)	BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity	Change from baseline (pre surgery) BMI at 1 year after the surgery
Change in Body Mass Index (BMI)	BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity	Change from baseline (pre surgery) BMI at 2 years after the surgery

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Frédéric Lavoie, MD, M.Sc, CHUM

Publications and helpful links

General Publications

• Henckel J, Richards R, Lozhkin K, Harris S, Rodriguez y Baena FM, Barrett AR, Cobb JP. Very low-dose computed tomography for planning and outcome measurement in knee replacement. The imperial knee protocol. J Bone Joint Surg Br. 2006 Nov;88(11):1513-8. doi: 10.1302/0301-620X.88B11.17986.
• Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
• Cloutier JM. Long-term results after nonconstrained total knee arthroplasty. Clin Orthop Relat Res. 1991 Dec;(273):63-5.
• Goutallier D, Manicom O, Van Driessche S. [Total knee arthroplasty with bicruciate preservation: Comparison versus the same posterostabilized design at eight years follow-up]. Rev Chir Orthop Reparatrice Appar Mot. 2008 Oct;94(6):585-95. doi: 10.1016/j.rco.2008.04.012. Epub 2008 Jul 11. French.
• Goutallier D, Glorion C. [Critical assessment of the functional advantage of preserving the 2 cruciate ligaments in total knee prosthesis. Experience with the Hermes' prosthesis]. Acta Orthop Belg. 1991;57 Suppl 2:128-9. No abstract available. French.
• Insall JN, Binazzi R, Soudry M, Mestriner LA. Total knee arthroplasty. Clin Orthop Relat Res. 1985 Jan-Feb;(192):13-22.
• Komistek RD, Allain J, Anderson DT, Dennis DA, Goutallier D. In vivo kinematics for subjects with and without an anterior cruciate ligament. Clin Orthop Relat Res. 2002 Nov;(404):315-25. doi: 10.1097/00003086-200211000-00047.
• Komistek RD, Scott RD, Dennis DA, Yasgur D, Anderson DT, Hajner ME. In vivo comparison of femorotibial contact positions for press-fit posterior stabilized and posterior cruciate-retaining total knee arthroplasties. J Arthroplasty. 2002 Feb;17(2):209-16. doi: 10.1054/arth.2002.29329.
• Laskin RS. Choosing your implant: cemented, tricompartmental, and posterior stabilized. J Arthroplasty. 2005 Jun;20(4 Suppl 2):7-9. doi: 10.1016/j.arth.2005.03.012.
• Lee SY, Matsui N, Kurosaka M, Komistek RD, Mahfouz M, Dennis DA, Yoshiya S. A posterior-stabilized total knee arthroplasty shows condylar lift-off during deep knee bends. Clin Orthop Relat Res. 2005 Jun;(435):181-4. doi: 10.1097/01.blo.0000155013.31327.dc.
• van den Bekerom MP, Patt TW, Kleinhout MY, van der Vis HM, Albers GH. Early complications after high tibial osteotomy: a comparison of two techniques. J Knee Surg. 2008 Jan;21(1):68-74. doi: 10.1055/s-0030-1247797.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Knee Osteoarthritis; posterior-stabilized; kinematic; bicruciate-retaining
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 10.068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No