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NCT Number: NCT05380648

Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis

Osteoarthritis (OA) is the main cause of pain and disability in elderly. For knee OA, a total knee replacement (TKR) is an effective surgical treatment, and the majority of patients report substantial pain relief and functional improvement following surgery. However, 20-40% of patients undergoing TKR are dissatisfied with postsurgical outcome. Even after revision, some patients keep complaining of persisting pain.

In this study, the investigators will examine putative prognostic factors on the basis of the biopsychosocial model. Besides several psychological factors (measured with questionnaires), the investigators will assess structural impairments (such as radiographic severity of OA), functional impairments (muscle weakness and proprioceptive deficits), anesthetic procedures, immediate postoperative pain management, metabolic factors (body composition and hemoglobin A1c), inflammatory factors (C-Reactive Protein) and the investigators also will examine the role of altered central pain processing (CPP) (primary and secondary mechanical hyperalgesia, mechanical temporal summation, thermal primary and secondary hyperalgesia, endogenous pain modulation).

With a longitudinal study design, this study will explore which factors are predictive of poor outcome in knee OA patients after TKR. Moreover, the interrelationship between CPP, structural, functional, metabolic, inflammatory and psychological factors, and the clinical expression of knee OA (pain, symptoms, physical performance and quality of life) will be investigated.

Further research on the role of the aforementioned putative prognostic factors on postsurgical outcome could contribute to better management of these patients, since these factors may be particularly important for patient-tailored treatment.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Antwerp

Antwerp, 2610, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Knee OA patients >40 years awaiting TKR surgery. Both men and women of all ethnical backgrounds are included.

Exclusion criteria

  • Patients with diagnosis of neurological/ systemic diseases, possibly impacting pain
  • Patients who are not capable of understanding and speaking Dutch
  • Revision surgery

Treatment and study plan

Total knee arthroplasty

Procedure

Total knee arthroplasty surgery will be performed by different orthopedist.

Primary outcomes

  1. Pain intensity

    Time frame: Change from baseline pain intensity at 3 months postoperative

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

  2. Pain intensity

    Time frame: Change from baseline pain intensity at 1 year postoperative

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

  3. Pain intensity

    Time frame: Change from 3 months postoperative at 1 year postoperative

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

  4. Pain intensity

    Time frame: Baseline (preoperative)

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

  5. Pain intensity

    Time frame: 3 months postoperative

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

  6. Pain intensity

    Time frame: 1 year postoperative

    The subscale 'Pain' of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome measure. Minimum score is 0, maximum score is 36. Scores are always transformed to a 0-100 scale. The higher the score, the higher the pain intensity.

Secondary outcomes

  1. Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with quantitative sensory testing (QST): mechanical pain pressure threshold measured with digital algometer at the medial knee joint line, lateral knee joint line and m. Tibialis anterior of affected leg, m. extensor carpi radialis of non-dominant arm and forehead.

  2. Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with quantitative sensory testing (QST): mechanical pain pressure threshold measured with digital algometer at the medial knee joint line, lateral knee joint line and m. Tibialis anterior of affected leg, m. extensor carpi radialis of non-dominant arm and forehead.

  3. Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with quantitative sensory testing (QST): mechanical pain pressure threshold measured with digital algometer at the medial knee joint line, lateral knee joint line and m. Tibialis anterior of affected leg, m. extensor carpi radialis of non-dominant arm and forehead.

  4. Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Time frame: Baseline (preoperative)

    Measured with quantitative sensory testing (QST): mechanical pain pressure threshold measured with digital algometer at the medial knee joint line, lateral knee joint line and m. Tibialis anterior of affected leg, m. extensor carpi radialis of non-dominant arm and forehead.

  5. Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Time frame: 3 months postoperative

    Measured with quantitative sensory testing (QST): mechanical pain pressure threshold measured with digital algometer at the medial knee joint line, lateral knee joint line and m. Tibialis anterior of affected leg, m. extensor carpi radialis of non-dominant arm and forehead.

  6. Central pain processing: mechanical local and widespread hyperalgesia allodynia

    Time frame: 1 year postoperative

    Measured with quantitative sensory testing (QST): mechanical pain pressure threshold measured with digital algometer at the medial knee joint line, lateral knee joint line and m. Tibialis anterior of affected leg, m. extensor carpi radialis of non-dominant arm and forehead.

  7. Central pain processing: bottom-up sensitization

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with quantitative sensory testing (QST): temporal summation measured with a 60g Von Frey monofilament at the medial knee and lateral knee of affected leg, dorsal wrist of affected side

  8. Central pain processing: bottom-up sensitization

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with quantitative sensory testing (QST): temporal summation measured with a 60g Von Frey monofilament at the medial knee and lateral knee of affected leg, dorsal wrist of affected side

  9. Central pain processing: bottom-up sensitization

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with quantitative sensory testing (QST): temporal summation measured with a 60g Von Frey monofilament at the medial knee and lateral knee of affected leg, dorsal wrist of affected side

  10. Central pain processing: bottom-up sensitization

    Time frame: Baseline (preoperative)

    Measured with quantitative sensory testing (QST): temporal summation measured with a 60g Von Frey monofilament at the medial knee and lateral knee of affected leg, dorsal wrist of affected side

  11. Central pain processing: bottom-up sensitization

    Time frame: 3 months postoperative

    Measured with quantitative sensory testing (QST): temporal summation measured with a 60g Von Frey monofilament at the medial knee and lateral knee of affected leg, dorsal wrist of affected side

  12. Central pain processing: bottom-up sensitization

    Time frame: 1 year postoperative

    Measured with quantitative sensory testing (QST): temporal summation measured with a 60g Von Frey monofilament at the medial knee and lateral knee of affected leg, dorsal wrist of affected side

  13. Central pain processing: Thermal hyperalgesia

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with quantitative sensory testing (QST): thermal pain sensitivity measured with thermal rollers (Rolltemp II somedic senselab) at the medial knee and lateral knee of affected leg and m. extensor carpi radialis of non-dominant arm.

  14. Central pain processing: Thermal hyperalgesia

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with quantitative sensory testing (QST): thermal pain sensitivity measured with thermal rollers (Rolltemp II somedic senselab) at the medial knee and lateral knee of affected leg and m. extensor carpi radialis of non-dominant arm.

  15. Central pain processing: Thermal hyperalgesia

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with quantitative sensory testing (QST): thermal pain sensitivity measured with thermal rollers (Rolltemp II somedic senselab) at the medial knee and lateral knee of affected leg and m. extensor carpi radialis of non-dominant arm.

  16. Central pain processing: Thermal hyperalgesia

    Time frame: Baseline (preoperative)

    Measured with quantitative sensory testing (QST): thermal pain sensitivity measured with thermal rollers (Rolltemp II somedic senselab) at the medial knee and lateral knee of affected leg and m. extensor carpi radialis of non-dominant arm.

  17. Central pain processing: Thermal hyperalgesia

    Time frame: 3 months postoperative

    Measured with quantitative sensory testing (QST): thermal pain sensitivity measured with thermal rollers (Rolltemp II somedic senselab) at the medial knee and lateral knee of affected leg and m. extensor carpi radialis of non-dominant arm.

  18. Central pain processing: Thermal hyperalgesia

    Time frame: 1 year postoperative

    Measured with quantitative sensory testing (QST): thermal pain sensitivity measured with thermal rollers (Rolltemp II somedic senselab) at the medial knee and lateral knee of affected leg and m. extensor carpi radialis of non-dominant arm.

  19. Central pain processing: dysfunctional endogenous pain analgesia

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists

  20. Central pain processing: dysfunctional endogenous pain analgesia

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists

  21. Central pain processing: dysfunctional endogenous pain analgesia

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists

  22. Central pain processing: dysfunctional endogenous pain analgesia

    Time frame: Baseline (preoperative)

    Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists

  23. Central pain processing: dysfunctional endogenous pain analgesia

    Time frame: 3 months postoperative

    Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists

  24. Central pain processing: dysfunctional endogenous pain analgesia

    Time frame: 1 year postoperative

    Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists

  25. Central pain processing: somatic and emotional symptoms

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Questionnaire: the Central sensitization Inventory (CSI). Minimum score is 0, maximum score is 100. The higher the score, the higher the chance for the presence of central sensitization.

  26. Central pain processing: somatic and emotional symptoms

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Questionnaire: the Central sensitization Inventory (CSI). Minimum score is 0, maximum score is 100. The higher the score, the higher the chance for the presence of central sensitization.

  27. Central pain processing: somatic and emotional symptoms

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Questionnaire: the Central sensitization Inventory (CSI). Minimum score is 0, maximum score is 100. The higher the score, the higher the chance for the presence of central sensitization.

  28. Central pain processing: somatic and emotional symptoms

    Time frame: Baseline (preoperative)

    Questionnaire: the Central sensitization Inventory (CSI). Minimum score is 0, maximum score is 100. The higher the score, the higher the chance for the presence of central sensitization.

  29. Central pain processing: somatic and emotional symptoms

    Time frame: 3 months postoperative

    Questionnaire: the Central sensitization Inventory (CSI). Minimum score is 0, maximum score is 100. The higher the score, the higher the chance for the presence of central sensitization.

  30. Central pain processing: somatic and emotional symptoms

    Time frame: 1 year postoperative

    Questionnaire: the Central sensitization Inventory (CSI). Minimum score is 0, maximum score is 100. The higher the score, the higher the chance for the presence of central sensitization.

  31. Central pain processing: areas of pain

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization

  32. Central pain processing: areas of pain

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization

  33. Central pain processing: areas of pain

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization

  34. Central pain processing: areas of pain

    Time frame: Baseline (preoperative)

    Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization

  35. Central pain processing: areas of pain

    Time frame: 3 months postoperative

    Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization

  36. Central pain processing: areas of pain

    Time frame: 1 year postoperative

    Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization

  37. Psychosocial factors: pain catastrophizing

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.

  38. Psychosocial factors: pain catastrophizing

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.

  39. Psychosocial factors: pain catastrophizing

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.

  40. Psychosocial factors: pain catastrophizing

    Time frame: Baseline (preoperative)

    Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.

  41. Psychosocial factors: pain catastrophizing

    Time frame: 3 months postoperative

    Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.

  42. Psychosocial factors: pain catastrophizing

    Time frame: 1 year postoperative

    Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.

  43. Psychosocial factors: illness perceptions

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Illness perception questionnaire-revised (IPQ-R)

    • Identity dimension:

    yes = 1; no = 0 min score= 0, max score= 18

    • Other dimensions:

    min score= 38, max score= 190 strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5

    • Causal dimension:

    strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5 min score= 18, max score= 90

    High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.

    High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.

  44. Psychosocial factors: illness perceptions

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Illness perception questionnaire-revised (IPQ-R)

    • Identity dimension:

    yes = 1; no = 0 min score= 0, max score= 18

    • Other dimensions:

    min score= 38, max score= 190 strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5

    • Causal dimension:

    strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5 min score= 18, max score= 90

    High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.

    High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.

  45. Psychosocial factors: illness perceptions

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Illness perception questionnaire-revised (IPQ-R)

    • Identity dimension:

    yes = 1; no = 0 min score= 0, max score= 18

    • Other dimensions:

    min score= 38, max score= 190 strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5

    • Causal dimension:

    strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5 min score= 18, max score= 90

    High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.

    High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.

  46. Psychosocial factors: illness perceptions

    Time frame: Baseline (preoperative)

    Illness perception questionnaire-revised (IPQ-R)

    • Identity dimension:

    yes = 1; no = 0 min score= 0, max score= 18

    • Other dimensions:

    min score= 38, max score= 190 strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5

    • Causal dimension:

    strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5 min score= 18, max score= 90

    High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.

    High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.

  47. Psychosocial factors: illness perceptions

    Time frame: 3 months postoperative

    Illness perception questionnaire-revised (IPQ-R)

    • Identity dimension:

    yes = 1; no = 0 min score= 0, max score= 18

    • Other dimensions:

    min score= 38, max score= 190 strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5

    • Causal dimension:

    strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5 min score= 18, max score= 90

    High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.

    High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.

  48. Psychosocial factors: illness perceptions

    Time frame: 1 year postoperative

    Illness perception questionnaire-revised (IPQ-R)

    • Identity dimension:

    yes = 1; no = 0 min score= 0, max score= 18

    • Other dimensions:

    min score= 38, max score= 190 strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5

    • Causal dimension:

    strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5 min score= 18, max score= 90

    High scores on the identity, timeline, consequences, and cyclical dimensions represent strongly held beliefs about the number of symptoms attributed to the illness, the chronicity of the condition, the negative consequences of the illness, and the cyclical nature of the condition.

    High scores on the personal control, treatment control and coherence dimensions, represent positive beliefs about the controllability of the illness and a personal understanding of the condition.

  49. Psychosocial factors: anxiety

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale anxiety. Minimum score is 0, maximum score is 21. The higher the score, the higher the anxiety.

  50. Psychosocial factors: anxiety

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale anxiety. Minimum score is 0, maximum score is 21. The higher the score, the higher the anxiety.

  51. Psychosocial factors: anxiety

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale anxiety. Minimum score is 0, maximum score is 21. The higher the score, the higher the anxiety.

  52. Psychosocial factors: anxiety

    Time frame: Baseline (preoperative)

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale anxiety. Minimum score is 0, maximum score is 21. The higher the score, the higher the anxiety.

  53. Psychosocial factors: anxiety

    Time frame: 3 months postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale anxiety. Minimum score is 0, maximum score is 21. The higher the score, the higher the anxiety.

  54. Psychosocial factors: anxiety

    Time frame: 1 year postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale anxiety. Minimum score is 0, maximum score is 21. The higher the score, the higher the anxiety.

  55. Psychosocial factors: depression

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale depression. Minimum score is 0, maximum score is 21. The higher the score, the higher the depression.

  56. Psychosocial factors: depression

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale depression. Minimum score is 0, maximum score is 21. The higher the score, the higher the depression.

  57. Psychosocial factors: depression

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale depression. Minimum score is 0, maximum score is 21. The higher the score, the higher the depression.

  58. Psychosocial factors: depression

    Time frame: Baseline (preoperative)

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale depression. Minimum score is 0, maximum score is 21. The higher the score, the higher the depression.

  59. Psychosocial factors: depression

    Time frame: 3 months postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale depression. Minimum score is 0, maximum score is 21. The higher the score, the higher the depression.

  60. Psychosocial factors: depression

    Time frame: 1 year postoperative

    Measured with Hospital Anxiety and Depression Scale (HADS), subscale depression. Minimum score is 0, maximum score is 21. The higher the score, the higher the depression.

  61. Functional factors: Maximal voluntary muscle strength m. Hamstrings

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer

  62. Functional factors: Maximal voluntary muscle strength m. Hamstrings

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer

  63. Functional factors: Maximal voluntary muscle strength m. Hamstrings

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer

  64. Functional factors: Maximal voluntary muscle strength m. Hamstrings

    Time frame: 3 months postoperative

    Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer

  65. Functional factors: Maximal voluntary muscle strength m. Hamstrings

    Time frame: Baseline (preoperative)

    Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer

  66. Functional factors: Maximal voluntary muscle strength m. Hamstrings

    Time frame: 1 year postoperative

    Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer

  67. Functional factors: Maximal voluntary muscle strength m. Quadriceps

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer

  68. Functional factors: Maximal voluntary muscle strength m. Quadriceps

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer

  69. Functional factors: Maximal voluntary muscle strength m. Quadriceps

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer

  70. Functional factors: Maximal voluntary muscle strength m. Quadriceps

    Time frame: Baseline (preoperative)

    Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer

  71. Functional factors: Maximal voluntary muscle strength m. Quadriceps

    Time frame: 3 months postoperative

    Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer

  72. Functional factors: Maximal voluntary muscle strength m. Quadriceps

    Time frame: 1 year postoperative

    Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer

  73. Functional factors: proprioceptive accuracy

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Proprioception of the knee of both legs, measured with inclinometer

  74. Functional factors: proprioceptive accuracy

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Proprioception of the knee of both legs, measured with inclinometer

  75. Functional factors: proprioceptive accuracy

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Proprioception of the knee of both legs, measured with inclinometer

  76. Functional factors: proprioceptive accuracy

    Time frame: Baseline (preoperative)

    Proprioception of the knee of both legs, measured with inclinometer

  77. Functional factors: proprioceptive accuracy

    Time frame: 3 months postoperative

    Proprioception of the knee of both legs, measured with inclinometer

  78. Functional factors: proprioceptive accuracy

    Time frame: 1 year postoperative

    Proprioception of the knee of both legs, measured with inclinometer

  79. Functional factors: leg strength and endurance

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with 30 seconds Timed Chair-Stand-Test

  80. Functional factors: leg strength and endurance

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with 30 seconds Timed Chair-Stand-Test

  81. Functional factors: leg strength and endurance

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with 30 seconds Timed Chair-Stand-Test

  82. Functional factors: leg strength and endurance

    Time frame: Baseline (preoperative)

    Measured with 30 seconds Timed Chair-Stand-Test

  83. Functional factors: leg strength and endurance

    Time frame: 3 months postoperative

    Measured with 30 seconds Timed Chair-Stand-Test

  84. Functional factors: leg strength and endurance

    Time frame: 1 year postoperative

    Measured with 30 seconds Timed Chair-Stand-Test

  85. Patient demographics

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale patient demographics (nominal)

  86. Alignment

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale objective knee score 'alignment': weight-bearing anterior-posterior radiograph measuring the femoral-tibial (Anatomic) axis. Minimum is 0, maximum is 25. The higher the score, the better the alignment.

  87. Instability

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale objective knee score 'instability'. Minimum is 0, maximum is 25. The higher the score, the better the stability.

  88. Joint motion

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale objective knee score 'joint motion'. Minimum is 0, maximum can be higher than 25. One point for every joint motion of 5 degrees. The higher the score, the better the joint motion.

  89. Pain symptoms

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    measured with Knee Society Scoring System (KSS): subscale symptoms. Minimum score is 0, maximum score is 25. The higher the score, the worse the pain symptoms.

  90. Pain symptoms

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale symptoms. Minimum score is 0, maximum score is 25. The higher the score, the worse the pain symptoms.

  91. Pain symptoms

    Time frame: Change from 3 months postoperative to 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale symptoms. Minimum score is 0, maximum score is 25. The higher the score, the worse the pain symptoms.

  92. Pain symptoms

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale symptoms. Minimum score is 0, maximum score is 25. The higher the score, the worse the pain symptoms.

  93. Pain symptoms

    Time frame: 3 months postoperative

    measured with Knee Society Scoring System (KSS): subscale symptoms. Minimum score is 0, maximum score is 25. The higher the score, the worse the pain symptoms.

  94. Pain symptoms

    Time frame: 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale symptoms. Minimum score is 0, maximum score is 25. The higher the score, the worse the pain symptoms.

  95. Patient expectations

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale patient expectations. Minimum score is 0, maximum score is 15. The higher the score, the higher the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities

  96. Patient expectations fulfillment

    Time frame: 3 months postoperative

    measured with Knee Society Scoring System (KSS): subscale patient expectations. Minimum score is 0, maximum score is 15. The higher the score, the higher the patient's opinion on the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function

  97. Patient expectations fulfillment

    Time frame: 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale patient expectations. Minimum score is 0, maximum score is 15. The higher the score, the higher the patient's opinion on the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function

  98. Patient expectations fulfillment

    Time frame: Change from 3 months postoperative to 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale patient expectations. Minimum score is 0, maximum score is 15. The higher the score, the higher the patient's opinion on the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function

  99. Patient satisfaction

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    measured with Knee Society Scoring System (KSS): subscale patient satisfaction. Minimum score is 0, maximum score is 40. The higher the score, the more satisfied the patient feels with their knee.

  100. Patient satisfaction

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale patient satisfaction. Minimum score is 0, maximum score is 40. The higher the score, the more satisfied the patient feels with their knee.

  101. Patient satisfaction

    Time frame: Change from 3 months postoperative to 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale patient satisfaction. Minimum score is 0, maximum score is 40. The higher the score, the more satisfied the patient feels with their knee.

  102. Patient satisfaction

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale patient satisfaction. Minimum score is 0, maximum score is 40. The higher the score, the more satisfied the patient feels with their knee.

  103. Patient satisfaction

    Time frame: 3 months postoperative

    measured with Knee Society Scoring System (KSS): subscale patient satisfaction. Minimum score is 0, maximum score is 40. The higher the score, the more satisfied the patient feels with their knee.

  104. Patient satisfaction

    Time frame: 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale patient satisfaction. Minimum score is 0, maximum score is 40. The higher the score, the more satisfied the patient feels with their knee.

  105. Functional score

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    measured with Knee Society Scoring System (KSS): subscale functional score. Minimum score is 0, maximum score is 100. The higher the score, the better the functionality of the patient

  106. Functional score

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale functional score. Minimum score is 0, maximum score is 100. The higher the score, the better the functionality of the patient

  107. Functional score

    Time frame: Change from 3 months postoperative to 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale functional score. Minimum score is 0, maximum score is 100. The higher the score, the better the functionality of the patient

  108. Functional score

    Time frame: Baseline (preoperative)

    measured with Knee Society Scoring System (KSS): subscale functional score. Minimum score is 0, maximum score is 100. The higher the score, the better the functionality of the patient

  109. Functional score

    Time frame: 3 months postoperative

    measured with Knee Society Scoring System (KSS): subscale functional score. Minimum score is 0, maximum score is 100. The higher the score, the better the functionality of the patient

  110. Functional score

    Time frame: 1 year postoperative

    measured with Knee Society Scoring System (KSS): subscale functional score. Minimum score is 0, maximum score is 100. The higher the score, the better the functionality of the patient

  111. Metabolic factors: Fat mass

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  112. Metabolic factors: Fat mass

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  113. Metabolic factors: Fat mass

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  114. Metabolic factors: Fat mass

    Time frame: Baseline (preoperative)

    Measured with Bio-electrical Impedance Analyses (BIA)

  115. Metabolic factors: Fat mass

    Time frame: 3 months postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  116. Metabolic factors: Fat mass

    Time frame: 1 year postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  117. Metabolic factors: Lean mass

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  118. Metabolic factors: Lean mass

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  119. Metabolic factors: Lean mass

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  120. Metabolic factors: Lean mass

    Time frame: Baseline (preoperative)

    Measured with Bio-electrical Impedance Analyses (BIA)

  121. Metabolic factors: Lean mass

    Time frame: 3 months postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  122. Metabolic factors: Lean mass

    Time frame: 1 year postoperative

    Measured with Bio-electrical Impedance Analyses (BIA)

  123. Metabolic factors: Body mass index (BMI)

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with length of patient (cm) and weight of patient (kg)

  124. Metabolic factors: Body mass index (BMI)

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with length of patient (cm) and weight of patient (kg)

  125. Metabolic factors: Body mass index (BMI)

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with length of patient (cm) and weight of patient (kg)

  126. Metabolic factors: Body mass index (BMI)

    Time frame: Baseline (preoperative)

    Measured with length of patient (cm) and weight of patient (kg)

  127. Metabolic factors: Body mass index (BMI)

    Time frame: 3 months postoperative

    Measured with length of patient (cm) and weight of patient (kg)

  128. Metabolic factors: Body mass index (BMI)

    Time frame: 1 year postoperative

    Measured with length of patient (cm) and weight of patient (kg)

  129. Metabolic factors: body composition

    Time frame: Baseline (preoperative), 3 months postoperative, 1 year postoperative.

    Measured with Bioelectrical Impedance Analysis (BIA)

  130. Metabolic factors: venous blood sample

    Time frame: Change from baseline (preoperative) to 3 months postoperative

    Measured with A1C test or glycohemoglobin test

  131. Metabolic factors: venous blood sample

    Time frame: Change from baseline (preoperative) to 1 year postoperative

    Measured with A1C test or glycohemoglobin test

  132. Metabolic factors: venous blood sample

    Time frame: Change from 3 months postoperative to 1 year postoperative

    Measured with A1C test or glycohemoglobin test

  133. Metabolic factors: venous blood sample

    Time frame: Baseline (preoperative)

    Measured with A1C test or glycohemoglobin test

  134. Metabolic factors: venous blood sample

    Time frame: 3 months postoperative

    Measured with A1C test or glycohemoglobin test

  135. Metabolic factors: venous blood sample

    Time frame: 1 year postoperative.

    Measured with A1C test or glycohemoglobin test

  136. Structural factors

    Time frame: Baseline (preoperative)

    Measured with Kellgren and Lawrence scale on radiography

  137. Inflammatory factors: signs of inflammation

    Time frame: Baseline (preoperative)

    Measured with the C-reactive protein levels in blood sample (collected from patient record)

  138. Anesthetic procedure

    Time frame: During surgery

    General anesthesia, spinal anesthesia or combination with peripheral block

  139. Clinical pain score

    Time frame: day 1 and 2 postoperative

    Measured with numeric rating pain scale

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Registry information

Official study title

Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis: a Prospective Study on the Role of Altered Central Pain Processing and Structural, Functional, Metabolic, Inflammatory and Psychological Factors

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 19, 2022
Registry last updated
Dec 29, 2023

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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