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NCT Number: NCT05469776

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Total Knee Arthroplasty Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bicruciate-retaining total knee arthroplasty

Procedure

posterior-stabilized total knee arthroplasty

Procedure

Primary outcomes

  1. Change in KOOS pain score

    Time frame: 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

Secondary outcomes

  1. Change in KOOS pain score

    Time frame: Change from baseline (pre surgery) KOOS pain score at 6 weeks after the surgery

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

  2. Change in KOOS pain score

    Time frame: Change from baseline (pre surgery) KOOS pain score at 6 months after the surgery

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

  3. Change in KOOS pain score

    Time frame: Change from baseline (pre surgery) KOOS pain score at 1 year after the surgery

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

  4. Change in KOOS pain score

    Time frame: Change from baseline (pre surgery) KOOS pain score at 2 years after the surgery

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

  5. Change in KOOS pain score

    Time frame: Change from baseline (pre surgery) KOOS pain score at 5 years after the surgery

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

  6. Change in KOOS symptoms score

    Time frame: Change from baseline (pre surgery) KOOS pain symptoms at 6 weeks after the surgery

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

  7. Change in KOOS symptoms score

    Time frame: Change from baseline (pre surgery) KOOS symptoms score at 6 months after the surgery

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

  8. Change in KOOS symptoms score

    Time frame: Change from baseline (pre surgery) KOOS symptoms score at 1 year after the surgery

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

  9. Change in KOOS symptoms score

    Time frame: Change from baseline (pre surgery) KOOS symptoms score at 2 years after the surgery

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

  10. Change in KOOS symptoms score

    Time frame: Change from baseline (pre surgery) KOOS pain symptoms at 5 years after the surgery

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

  11. Change in KOOS symptoms score

    Time frame: Change from baseline (pre surgery) KOOS pain symptoms at 10 years after the surgery

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

  12. Change in KOOS activity of daily living score

    Time frame: Change from baseline (pre surgery) KOOS activity of daily living at 6 weeks after the surgery

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

  13. Change in KOOS activity of daily living score

    Time frame: Change from baseline (pre surgery) KOOS activity of daily living score at 6 months after the surgery

    KOOS activity of daily living score; 0-100 scale, 0: extreme problems 100: no problems

  14. Change in KOOS activity of daily living score

    Time frame: Change from baseline (pre surgery) KOOS activity of daily living score at 1 year after the surgery

    KOOS activity of daily living score; 0-100 scale, 0: extreme problems 100: no problems

  15. Change in KOOS activity of daily living score

    Time frame: Change from baseline (pre surgery) KOOS activity of daily living score at 2 years after the surgery

    KOOS activity of daily living score; 0-100 scale, 0: extreme problems 100: no problems

  16. Change in KOOS activity of daily living score

    Time frame: Change from baseline (pre surgery) KOOS activity of daily living at 5 years after the surgery

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

  17. Change in KOOS activity of daily living score

    Time frame: Change from baseline (pre surgery) KOOS activity of daily living at 10 years after the surgery

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

  18. Change in KOOS sport and recreation score

    Time frame: Change from baseline (pre surgery) KOOS sport and recreation at 6 weeks after the surgery

    KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems

  19. Change in KOOS sport and recreation score

    Time frame: Change from baseline (pre surgery) KOOS sport and recreation score at 6 months after the surgery

    KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems

  20. Change in KOOS sport and recreation score

    Time frame: Change from baseline (pre surgery) KOOS sport and recreation score at 1 year after the surgery

    KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems

  21. Change in KOOS sport and recreation score

    Time frame: Change from baseline (pre surgery) KOOS sport and recreation score at 2 years after the surgery

    KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems

  22. Change in KOOS sport and recreation score

    Time frame: Change from baseline (pre surgery) KOOS sport and recreation at 5 years after the surgery

    KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems

  23. Change in KOOS sport and recreation score

    Time frame: Change from baseline (pre surgery) KOOS sport and recreation at 10 years after the surgery

    KOOS sport and recreation score; 0-100 scale, 0: extreme problems 100: no problems

  24. Change in KOOS quality of life score

    Time frame: Change from baseline (pre surgery) KOOS quality of life at 6 weeks after the surgery

    KOOS quality of life score score; 0-100 scale, 0: extreme problems 100: no problems

  25. Change in KOOS quality of life score

    Time frame: Change from baseline (pre surgery) KOOS quality of life score at 6 months after the surgery

    KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems

  26. Change in KOOS quality of life score

    Time frame: Change from baseline (pre surgery) KOOS quality of life score at 1 year after the surgery

    KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems

  27. Change in KOOS quality of life score

    Time frame: Change from baseline (pre surgery) KOOS quality of life score at 2 years after the surgery

    KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems

  28. Change in KOOS quality of life score

    Time frame: Change from baseline (pre surgery) KOOS quality of life at 5 years after the surgery

    KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems

  29. Change in KOOS quality of life score

    Time frame: Change from baseline (pre surgery) KOOS quality of life at 10 years after the surgery

    KOOS quality of life score; 0-100 scale, 0: extreme problems 100: no problems

  30. Change in MARX score

    Time frame: Change from baseline (pre surgery) MARX score at 6 weeks after the surgery

    MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

  31. Change in MARX score

    Time frame: Change from baseline (pre surgery) MARX score at 6 months after the surgery

    MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

  32. Change in MARX score

    Time frame: Change from baseline (pre surgery) MARX score at 1 year after the surgery

    MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

  33. Change in MARX score

    Time frame: Change from baseline (pre surgery) MARX score at 2 years after the surgery

    MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

  34. Change in MARX score

    Time frame: Change from baseline (pre surgery) MARX score at 5 yearss after the surgery

    MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

  35. Change in MARX score

    Time frame: Change from baseline (pre surgery) MARX score at 10 yearss after the surgery

    MARX activity rating scale; 0-16, 0: less frequent sport participation 16: more frequent sport participation

  36. Change in International Knee Society scoring system (IKS) : knee score

    Time frame: Change from baseline (pre surgery) IKS Knee score at 6 weeks after the surgery

    IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee

  37. Change in International Knee Society scoring system (IKS) : knee score

    Time frame: Change from baseline (pre surgery) IKS Knee score at 6 months after the surgery

    IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee

  38. Change in International Knee Society scoring system (IKS) : knee score

    Time frame: Change from baseline (pre surgery) IKS Knee score at 1 year after the surgery

    IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee

  39. Change in International Knee Society scoring system (IKS) : knee score

    Time frame: Change from baseline (pre surgery) IKS Knee score at 2 years after the surgery

    IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee

  40. Change in International Knee Society scoring system (IKS) : knee score

    Time frame: Change from baseline (pre surgery) IKS Knee score at 5 years after the surgery

    IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee

  41. Change in International Knee Society scoring system (IKS) : knee score

    Time frame: Change from baseline (pre surgery) IKS Knee score at 10 years after the surgery

    IKS Knee score; 0-100, 0: poor condition of the knee 100: better condition of the knee

  42. Change in International Knee Society scoring system (IKS) : function score

    Time frame: Change from baseline (pre surgery) IKS function score at 6 weeks after the surgery

    IKS Knee score; 0-100, 0: severe functional disability 100: no disability

  43. Change in International Knee Society scoring system (IKS) : function score

    Time frame: Change from baseline (pre surgery) IKS function score at 6 months after the surgery

    IKS Knee score; 0-100, 0: severe functional disability 100: no disability

  44. Change in International Knee Society scoring system (IKS) : function score

    Time frame: Change from baseline (pre surgery) IKS function score at 1 year after the surgery

    IKS Knee score; 0-100, 0: severe functional disability 100: no disability

  45. Change in International Knee Society scoring system (IKS) : function score

    Time frame: Change from baseline (pre surgery) IKS function score at 2 years after the surgery

    IKS Knee score; 0-100, 0: severe functional disability 100: no disability

  46. Change in International Knee Society scoring system (IKS) : function score

    Time frame: Change from baseline (pre surgery) IKS function score at 5 years after the surgery

    IKS Knee score; 0-100, 0: severe functional disability 100: no disability

  47. Change in International Knee Society scoring system (IKS) : function score

    Time frame: Change from baseline (pre surgery) IKS function score at 10 years after the surgery

    IKS Knee score; 0-100, 0: severe functional disability 100: no disability

  48. Change in Knee Range of Motion (ROM)

    Time frame: Change from baseline (pre surgery) ROM at 6 weeks after the surgery

    Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160

  49. Change in Knee Range of Motion (ROM)

    Time frame: Change from baseline (pre surgery) ROM at 6 months after the surgery

    Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160

  50. Change in Knee Range of Motion (ROM)

    Time frame: Change from baseline (pre surgery) ROM at 1 year after the surgery

    Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160

  51. Change in Knee Range of Motion (ROM)

    Time frame: Change from baseline (pre surgery) ROM at 2 years after the surgery

    Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160

  52. Change in Knee Range of Motion (ROM)

    Time frame: Change from baseline (pre surgery) ROM at 5 years after the surgery

    Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160

  53. Change in Knee Range of Motion (ROM)

    Time frame: Change from baseline (pre surgery) ROM at 10 years after the surgery

    Genu Recurvatum, Genu Flexum and Knee maximal flexion, angle in degrees ranging from 0 to 160

  54. Change in Lower limb morphology in the coronal plane

    Time frame: Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 6 weeks after the surgery

    Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

  55. Change in Lower limb morphology in the coronal plane

    Time frame: Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 6 months after the surgery

    Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

  56. Change in Lower limb morphology in the coronal plane

    Time frame: Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 1 year after the surgery

    Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

  57. Change in Lower limb morphology in the coronal plane

    Time frame: Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 2 years after the surgery

    Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

  58. Change in Lower limb morphology in the coronal plane

    Time frame: Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 5 years after the surgery

    Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

  59. Change in Lower limb morphology in the coronal plane

    Time frame: Change from baseline (pre surgery) Lower limb morphology in the coronal plane at 10 years after the surgery

    Lower limb morphology in the coronal plane; neutral: 176-184 degrees varus: <176 degrees valgus: > 184 degrees

  60. Change in Knee alignment : Hip-knee-ankle (HKA)

    Time frame: Change from baseline (pre surgery) HKA at 6 weeks after the surgery

    Hip-knee-ankle (HKA); 150-210 degrees

  61. Change in Knee alignment : Hip-knee-ankle (HKA)

    Time frame: Change from baseline (pre surgery) HKA at 6 months after the surgery

    Hip-knee-ankle (HKA); 150-210 degrees

  62. Change in Knee alignment : Hip-knee-ankle (HKA)

    Time frame: Change from baseline (pre surgery) HKA at 1 year after the surgery

    Hip-knee-ankle (HKA); 150-210 degrees

  63. Change in Knee alignment : Hip-knee-ankle (HKA)

    Time frame: Change from baseline (pre surgery) HKA at 2 years after the surgery

    Hip-knee-ankle (HKA); 150-210 degrees

  64. Change in Knee alignment : Hip-knee-ankle (HKA)

    Time frame: Change from baseline (pre surgery) HKA at 5 years after the surgery

    Hip-knee-ankle (HKA); 150-210 degrees

  65. Change in Knee alignment : Hip-knee-ankle (HKA)

    Time frame: Change from baseline (pre surgery) HKA at 10 years after the surgery

    Hip-knee-ankle (HKA); 150-210 degrees

  66. Change in Knee alignment : Hip-knee-shaft (HKS)

    Time frame: Change from baseline (pre surgery) HKS at 6 weeks after the surgery

    Hip-knee-shaft (HKS); 2-15 degrees

  67. Change in Knee alignment : Hip-knee-shaft (HKS)

    Time frame: Change from baseline (pre surgery) HKS at 6 months after the surgery

    Hip-knee-shaft (HKS); 2-15 degrees

  68. Change in Knee alignment : Hip-knee-shaft (HKS)

    Time frame: Change from baseline (pre surgery) HKS at 1 year after the surgery

    Hip-knee-shaft (HKS); 2-15 degrees

  69. Change in Knee alignment : Hip-knee-shaft (HKS)

    Time frame: Change from baseline (pre surgery) HKS at 2 years after the surgery

    Hip-knee-shaft (HKS); 2-15 degrees

  70. Change in Knee alignment : Hip-knee-shaft (HKS)

    Time frame: Change from baseline (pre surgery) HKS at 5 years after the surgery

    Hip-knee-shaft (HKS); 2-15 degrees

  71. Change in Knee alignment : Hip-knee-shaft (HKS)

    Time frame: Change from baseline (pre surgery) HKS at 10 years after the surgery

    Hip-knee-shaft (HKS); 2-15 degrees

  72. Change in Knee alignment : Medial distal femoral angle (MDFA)

    Time frame: Change from baseline (pre surgery) MDFA at 6 weeks after the surgery

    Medial distal femoral angle (MDFA); 75-100 degrees

  73. Change in Knee alignment : Medial distal femoral angle (MDFA)

    Time frame: Change from baseline (pre surgery) MDFA at 6 months after the surgery

    Medial distal femoral angle (MDFA); 75-100 degrees

  74. Change in Knee alignment : Medial distal femoral angle (MDFA)

    Time frame: Change from baseline (pre surgery) MDFA at 1 year after the surgery

    Medial distal femoral angle (MDFA); 75-100 degrees

  75. Change in Knee alignment : Medial distal femoral angle (MDFA)

    Time frame: Change from baseline (pre surgery) MDFA at 2 years after the surgery

    Medial distal femoral angle (MDFA); 75-100 degrees

  76. Change in Knee alignment : Medial distal femoral angle (MDFA)

    Time frame: Change from baseline (pre surgery) MDFA at 5 years after the surgery

    Medial distal femoral angle (MDFA); 75-100 degrees

  77. Change in Knee alignment : Medial distal femoral angle (MDFA)

    Time frame: Change from baseline (pre surgery) MDFA at 10 years after the surgery

    Medial distal femoral angle (MDFA); 75-100 degrees

  78. Change in Knee alignment : Medial proximal tibial angle (MPTA)

    Time frame: Change from baseline (pre surgery) MPTA at 6 weeks after the surgery

    Medial proximal tibial angle (MPTA); 70-110 degrees

  79. Change in Knee alignment : Medial proximal tibial angle (MPTA)

    Time frame: Change from baseline (pre surgery) MPTA at 6 months after the surgery

    Medial proximal tibial angle (MPTA); 70-110 degrees

  80. Change in Knee alignment : Medial proximal tibial angle (MPTA)

    Time frame: Change from baseline (pre surgery) MPTA at 1 year after the surgery

    Medial proximal tibial angle (MPTA); 70-110 degrees

  81. Change in Knee alignment : Medial proximal tibial angle (MPTA)

    Time frame: Change from baseline (pre surgery) MPTA at 2 years after the surgery

    Medial proximal tibial angle (MPTA); 70-110 degrees

  82. Change in Knee alignment : Medial proximal tibial angle (MPTA)

    Time frame: Change from baseline (pre surgery) MPTA at 5 years after the surgery

    Medial proximal tibial angle (MPTA); 70-110 degrees

  83. Change in Knee alignment : Medial proximal tibial angle (MPTA)

    Time frame: Change from baseline (pre surgery) MPTA at 10 years after the surgery

    Medial proximal tibial angle (MPTA); 70-110 degrees

  84. Change in Knee ligament laxity : Anterior/Posterior Instability

    Time frame: Change from baseline (pre surgery) Anterior/Posterior Instability at 6 weeks after the surgery

    Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm

  85. Change in Knee ligament laxity : Anterior/Posterior Instability

    Time frame: Change from baseline (pre surgery) Anterior/Posterior Instability at 6 months after the surgery

    Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm

  86. Change in Knee ligament laxity : Anterior/Posterior Instability

    Time frame: Change from baseline (pre surgery) Anterior/Posterior Instability at 1 year after the surgery

    Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm

  87. Change in Knee ligament laxity : Anterior/Posterior Instability

    Time frame: Change from baseline (pre surgery) Anterior/Posterior Instability at 2 years after the surgery

    Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm

  88. Change in Knee ligament laxity : Anterior/Posterior Instability

    Time frame: Change from baseline (pre surgery) Anterior/Posterior Instability at 5 years after the surgery

    Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm

  89. Change in Knee ligament laxity : Anterior/Posterior Instability

    Time frame: Change from baseline (pre surgery) Anterior/Posterior Instability at 10 years after the surgery

    Anterior/Posterior Instability; measured at 90 degrees; none, moderate < 5mm, severe >5 mm

  90. Change in Knee ligament laxity : Medial/Lateral Instability

    Time frame: Change from baseline (pre surgery) Medial/Lateral Instability at 6 weeks after the surgery

    Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

  91. Change in Knee ligament laxity : Medial/Lateral Instability

    Time frame: Change from baseline (pre surgery) Medial/Lateral Instability at 6 months after the surgery

    Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

  92. Change in Knee ligament laxity : Medial/Lateral Instability

    Time frame: Change from baseline (pre surgery) Medial/Lateral Instability at 1 year after the surgery

    Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

  93. Change in Knee ligament laxity : Medial/Lateral Instability

    Time frame: Change from baseline (pre surgery) Medial/Lateral Instability at 2 years after the surgery

    Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

  94. Change in Knee ligament laxity : Medial/Lateral Instability

    Time frame: Change from baseline (pre surgery) Medial/Lateral Instability at 5 years after the surgery

    Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

  95. Change in Knee ligament laxity : Medial/Lateral Instability

    Time frame: Change from baseline (pre surgery) Medial/Lateral Instability at 10 years after the surgery

    Medial/Lateral Instability; measured in full extension; none, little < 5 mm, moderate = 5mm, severe > 5 mm

  96. Change in Patellar apprehension test

    Time frame: Change from baseline (pre surgery) Patellofemoral Instability at 6 weeks after the surgery

    Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

  97. Change in Patellar apprehension test

    Time frame: Change from baseline (pre surgery) Patellofemoral Instability at 6 months after the surgery

    Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

  98. Change in Patellar apprehension test

    Time frame: Change from baseline (pre surgery) Patellofemoral Instability at 1 year after the surgery

    Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

  99. Change in Patellar apprehension test

    Time frame: Change from baseline (pre surgery) Patellofemoral Instability at 2 years after the surgery

    Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

  100. Change in Patellar apprehension test

    Time frame: Change from baseline (pre surgery) Patellofemoral Instability at 5 years after the surgery

    Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

  101. Change in Patellar apprehension test

    Time frame: Change from baseline (pre surgery) Patellofemoral Instability at 10 years after the surgery

    Clinical physical examination for patellofemoral instability; Patellar apprehension test; normal, apprehension, apprehension and dislocation

  102. Change in Physical Activity Level Scale

    Time frame: Change from baseline (pre surgery) Physical Activity Level at 6 weeks after the surgery

    Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive

  103. Change in Physical Activity Level Scale

    Time frame: Change from baseline (pre surgery) Physical Activity Level at 6 months after the surgery

    Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive

  104. Change in Physical Activity Level Scale

    Time frame: Change from baseline (pre surgery) Physical Activity Level at 1 year after the surgery

    Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive

  105. Change in Physical Activity Level Scale

    Time frame: Change from baseline (pre surgery) Physical Activity Level at 2 years after the surgery

    Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive

  106. Change in Physical Activity Level Scale

    Time frame: Change from baseline (pre surgery) Physical Activity Level at 5 years after the surgery

    Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive

  107. Change in Physical Activity Level Scale

    Time frame: Change from baseline (pre surgery) Physical Activity Level at 10 years after the surgery

    Physical Activity Level Scale; None, Mild, Moderate, Strenuous, Competitive

  108. Change in Physical Activities Scale

    Time frame: Change from baseline (pre surgery) Physical Activities at 6 weeks after the surgery

    Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

  109. Change in Physical Activities Scale

    Time frame: Change from baseline (pre surgery) Physical Activities at 6 months after the surgery

    Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

  110. Change in Physical Activities Scale

    Time frame: Change from baseline (pre surgery) Physical Activities at 1 year after the surgery

    Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

  111. Change in Physical Activities Scale

    Time frame: Change from baseline (pre surgery) Physical Activities at 2 years after the surgery

    Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

  112. Change in Physical Activities Scale

    Time frame: Change from baseline (pre surgery) Physical Activities at 5 years after the surgery

    Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

  113. Change in Physical Activities Scale

    Time frame: Change from baseline (pre surgery) Physical Activities at 10 years after the surgery

    Physical Activities Scale; Sedentary / very little, Physical work, Aerobic, Sport(s) without pivot, Sport(s) with pivot

  114. Change in 12-Item Short Form Survey (SF-12) score

    Time frame: Change from baseline (pre surgery) SF-12 Questionnaire at 6 weeks after the surgery

    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.

  115. Change in 12-Item Short Form Survey (SF-12) score

    Time frame: Change from baseline (pre surgery) SF-12 Questionnaire at 6 months after the surgery

    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.

  116. Change in 12-Item Short Form Survey (SF-12) score

    Time frame: Change from baseline (pre surgery) SF-12 Questionnaire at 1 year after the surgery

    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.

  117. Change in 12-Item Short Form Survey (SF-12) score

    Time frame: Change from baseline (pre surgery) SF-12 Questionnaire at 2 years after the surgery

    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.

  118. Change in 12-Item Short Form Survey (SF-12) score

    Time frame: Change from baseline (pre surgery) SF-12 Questionnaire at 5 years after the surgery

    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.

  119. Change in 12-Item Short Form Survey (SF-12) score

    Time frame: Change from baseline (pre surgery) SF-12 Questionnaire at 10 years after the surgery

    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.

  120. Change in TELOS radiological laximetry

    Time frame: Change from baseline (pre surgery) TELOS radiological laximetry at 1 year after the surgery

    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

  121. Change in EOS imaging pseudo-kinematic - standardized squatting task - knee flexion and extension

    Time frame: Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery

    EOS imaging of both knees during a standardized squatting task; knee rotation around the media-lateral axis (knee flexion and extension), degrees

  122. Change in EOS imaging pseudo-kinematic - standardized squatting task - knee abduction and adduction

    Time frame: Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery

    EOS imaging of both knees during a standardized squatting task; knee rotation around the anteroposterior axis (knee abduction and adduction), degrees

  123. Change in EOS imaging pseudo-kinematic - standardized squatting task - knee internal and external rotation

    Time frame: Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery

    EOS imaging of both knees during a standardized squatting task; knee rotation around the longitudinal axis (knee internal and external rotation), degrees

  124. Change in EOS imaging pseudo-kinematic - free squatting task - knee flexion and extension

    Time frame: Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery

    EOS imaging of both knees during a free squatting task; knee rotation around the media-lateral axis (knee flexion and extension), degrees

  125. Change in EOS imaging pseudo-kinematic - free squatting task - knee abduction and adduction

    Time frame: Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery

    EOS imaging of both knees during a free squatting task; knee rotation around the anteroposterior axis (knee abduction and adduction), degrees

  126. Change in EOS imaging pseudo-kinematic - free squatting task - knee internal and external rotation

    Time frame: Change from baseline (pre surgery) EOS imaging pseudo-kinematic at 1 year after the surgery

    EOS imaging of both knees during a free squatting task; knee rotation around the longitudinal axis (knee internal and external rotation), degrees

  127. Changes in 3D knee kinematics assessment during walking - knee flexion and extension

    Time frame: Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery

    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

  128. Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee abduction and adduction

    Time frame: Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery

    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

  129. Changes in 3D knee kinematics assessment during walking measured with the KneeKG system - knee internal and external rotation

    Time frame: Change from baseline (pre surgery) 3D kinematics assessment at 1 year after the surgery

    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

Other outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Change from baseline (pre surgery) BMI at 6 weeks after the surgery

    BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity

  2. Change in Body Mass Index (BMI)

    Time frame: Change from baseline (pre surgery) BMI at 6 months after the surgery

    BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity

  3. Change in Body Mass Index (BMI)

    Time frame: Change from baseline (pre surgery) BMI at 1 year after the surgery

    BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity

  4. Change in Body Mass Index (BMI)

    Time frame: Change from baseline (pre surgery) BMI at 2 years after the surgery

    BMI; <18.5->30, <18.5: underweight 18.5-24.9: normal weight 25.0-29.9: overweight >30.0: obesity

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2031
Study completion
2031
First posted
Jul 22, 2022
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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