AzTrials
AzTrials

Total Knee ArthroplastyNCT05469776

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

A study testing bicruciate-retaining total knee arthroplasty and posterior-stabilized total knee arthroplasty in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Total Knee Arthroplasty, Knee Osteoarthritis
What is being tested?
bicruciate-retaining total knee arthroplasty and posterior-stabilized total knee arthroplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteCanada
Study dates
1 Jan 2011to 31 Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0C1

Other trials in Canada

About this study

Official title: 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
Read the 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.

Being tested
bicruciate-retaining total knee arthroplasty, posterior-stabilized total knee arthroplasty
Keywords
bicruciate-retaining, posterior-stabilized, Total Knee Arthroplasty, Knee Osteoarthritis, kinematic
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bicruciate-retaining total knee arthroplastyProcedure or surgery

  • posterior-stabilized total knee arthroplastyProcedure or surgery

Study groups in NCT05469776
Study groupRoleWhat they receive
bicruciate-retaining total knee arthroplastyExperimentalThe prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented.
Receives: Procedure: bicruciate-retaining total knee arthroplasty
posterior-stabilized total knee arthroplastyActive comparatorThe prosthesis requires the excision of both cruciate ligaments
Receives: Procedure: posterior-stabilized total knee arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in KOOS pain score

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

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

Secondary outcomes (129)

  1. Change in KOOS pain score

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

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

  2. Change in KOOS pain score

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

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

  3. Change in KOOS pain score

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

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

  4. Change in KOOS pain score

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

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

  5. Change in KOOS pain score

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

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

  6. Change in KOOS symptoms score

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

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

  7. Change in KOOS symptoms score

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

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

  8. Change in KOOS symptoms score

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

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

  9. Change in KOOS symptoms score

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

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

  10. Change in KOOS symptoms score

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

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

  11. Change in KOOS symptoms score

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

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

  12. Change in KOOS activity of daily living score

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

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

  13. Change in KOOS activity of daily living score

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

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

  14. Change in KOOS activity of daily living score

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

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

  15. Change in KOOS activity of daily living score

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

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

  16. Change in KOOS activity of daily living score

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

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

  17. Change in KOOS activity of daily living score

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

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

  18. Change in KOOS sport and recreation score

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

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

  19. Change in KOOS sport and recreation score

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

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

  20. Change in KOOS sport and recreation score

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

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

  21. Change in KOOS sport and recreation score

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

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

  22. Change in KOOS sport and recreation score

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

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

  23. Change in KOOS sport and recreation score

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

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

  24. Change in KOOS quality of life score

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

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

  25. Change in KOOS quality of life score

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

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

  26. Change in KOOS quality of life score

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

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

  27. Change in KOOS quality of life score

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

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

  28. Change in KOOS quality of life score

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

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

  29. Change in KOOS quality of life score

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

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

  30. Change in MARX score

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

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

  31. Change in MARX score

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

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

  32. Change in MARX score

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

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

  33. Change in MARX score

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

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

  34. Change in MARX score

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

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

  35. Change in MARX score

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

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

  36. 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

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

  37. 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

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

  38. 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

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

  39. 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

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

  40. 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

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

  41. 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  48. Change in Knee Range of Motion (ROM)

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

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

  49. Change in Knee Range of Motion (ROM)

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

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

  50. Change in Knee Range of Motion (ROM)

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

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

  51. Change in Knee Range of Motion (ROM)

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

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

  52. Change in Knee Range of Motion (ROM)

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

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

  53. Change in Knee Range of Motion (ROM)

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

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

  54. 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

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

  55. 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

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

  56. 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

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

  57. 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

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

  58. 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

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

  59. 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  96. Change in Patellar apprehension test

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

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

  97. Change in Patellar apprehension test

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

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

  98. Change in Patellar apprehension test

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

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

  99. Change in Patellar apprehension test

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

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

  100. Change in Patellar apprehension test

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

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

  101. Change in Patellar apprehension test

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

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

  102. Change in Physical Activity Level Scale

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

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

  103. Change in Physical Activity Level Scale

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

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

  104. Change in Physical Activity Level Scale

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

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

  105. Change in Physical Activity Level Scale

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

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

  106. Change in Physical Activity Level Scale

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

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

  107. Change in Physical Activity Level Scale

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

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

  108. Change in Physical Activities Scale

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

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

  109. Change in Physical Activities Scale

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

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

  110. Change in Physical Activities Scale

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

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

  111. Change in Physical Activities Scale

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

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

  112. Change in Physical Activities Scale

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

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

  113. Change in Physical Activities Scale

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

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

  114. 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.

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

  115. 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.

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

  116. 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.

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

  117. 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.

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

  118. 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.

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

  119. 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.

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

  120. 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

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

  121. 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

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

  122. 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

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

  123. 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

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

  124. 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

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

  125. 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

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

  126. 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

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

  127. 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

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

  128. 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

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

  129. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2022
  2. Study start1 Jan 2011
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469776
Sponsor's protocol ID
10.068
Status last verified
Aug 2024
First submitted
7 Jul 2022
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cloutier JM. Long-term results after nonconstrained total knee arthroplasty. Clin Orthop Relat Res. 1991 Dec;(273):63-5.

    PubMed 1959288

  • 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.

    PubMed 18929754

  • 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.

    PubMed 1792876

  • 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.

    PubMed 17075100

  • Insall JN, Binazzi R, Soudry M, Mestriner LA. Total knee arthroplasty. Clin Orthop Relat Res. 1985 Jan-Feb;(192):13-22.

    PubMed 3967412

  • 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.

    PubMed 2805470

  • 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.

    PubMed 12439275

  • 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.

    PubMed 11847622

  • 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.

    PubMed 15991119

  • 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.

    PubMed 15930936

  • 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.

    PubMed 18300676

Questions about this trial

What is this clinical trial studying?

A study testing bicruciate-retaining total knee arthroplasty and posterior-stabilized total knee arthroplasty in people with Total Knee Arthroplasty and Knee Osteoarthritis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in KOOS pain score (time frame: Change from baseline (pre surgery) KOOS pain score at 10 years after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469776, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in