Osteoarthritis, KneeNCT05380648
Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 223 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Mar 2018to 14 Jul 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Knee OA patients awaiting primary TKR surgery will be recruited at the University Hospital of Antwerp (BE), AZ Monica (BE), the academic hospital of Maastricht (NL) and St Jans Gasthuis Weert (NL). In each hospital, at least one orthopaedic surgeon already agreed to participate in this study and to recruit patients.
Who may be able to join
- Knee OA patients >40 years awaiting TKR surgery. Both men and women of all ethnical backgrounds are included.
Who cannot join
- Patients with diagnosis of neurological/ systemic diseases, possibly impacting pain
- Patients who are not capable of understanding and speaking Dutch
- Revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read more
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.
- Being tested
- Total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Total knee arthroplasty surgery will be performed by different orthopedist.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
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.
Measured: Change from baseline pain intensity at 3 months postoperative
Pain intensity
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.
Measured: Change from baseline pain intensity at 1 year postoperative
Pain intensity
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.
Measured: Change from 3 months postoperative at 1 year postoperative
Pain intensity
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.
Measured: Baseline (preoperative)
Pain intensity
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.
Measured: 3 months postoperative
Pain intensity
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.
Measured: 1 year postoperative
Secondary outcomes (139)
Central pain processing: mechanical local and widespread hyperalgesia allodynia
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
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.
Measured: Baseline (preoperative)
Central pain processing: mechanical local and widespread hyperalgesia allodynia
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.
Measured: 3 months postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
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.
Measured: 1 year postoperative
Central pain processing: bottom-up sensitization
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
Measured: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: bottom-up sensitization
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
Measured: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: bottom-up sensitization
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
Measured: Change from 3 months postoperative to 1 year postoperative
Central pain processing: bottom-up sensitization
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
Measured: Baseline (preoperative)
Central pain processing: bottom-up sensitization
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
Measured: 3 months postoperative
Central pain processing: bottom-up sensitization
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
Measured: 1 year postoperative
Central pain processing: Thermal hyperalgesia
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: Thermal hyperalgesia
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: Thermal hyperalgesia
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Central pain processing: Thermal hyperalgesia
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.
Measured: Baseline (preoperative)
Central pain processing: Thermal hyperalgesia
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.
Measured: 3 months postoperative
Central pain processing: Thermal hyperalgesia
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.
Measured: 1 year postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists
Measured: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists
Measured: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists
Measured: Change from 3 months postoperative to 1 year postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists
Measured: Baseline (preoperative)
Central pain processing: dysfunctional endogenous pain analgesia
Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists
Measured: 3 months postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists
Measured: 1 year postoperative
Central pain processing: somatic and emotional symptoms
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: somatic and emotional symptoms
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: somatic and emotional symptoms
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Central pain processing: somatic and emotional symptoms
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.
Measured: Baseline (preoperative)
Central pain processing: somatic and emotional symptoms
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.
Measured: 3 months postoperative
Central pain processing: somatic and emotional symptoms
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.
Measured: 1 year postoperative
Central pain processing: areas of pain
Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization
Measured: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: areas of pain
Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization
Measured: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: areas of pain
Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization
Measured: Change from 3 months postoperative to 1 year postoperative
Central pain processing: areas of pain
Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization
Measured: Baseline (preoperative)
Central pain processing: areas of pain
Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization
Measured: 3 months postoperative
Central pain processing: areas of pain
Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization
Measured: 1 year postoperative
Psychosocial factors: pain catastrophizing
Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.
Measured: Change from baseline (preoperative) to 3 months postoperative
Psychosocial factors: pain catastrophizing
Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.
Measured: Change from baseline (preoperative) to 1 year postoperative
Psychosocial factors: pain catastrophizing
Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.
Measured: Change from 3 months postoperative to 1 year postoperative
Psychosocial factors: pain catastrophizing
Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.
Measured: Baseline (preoperative)
Psychosocial factors: pain catastrophizing
Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.
Measured: 3 months postoperative
Psychosocial factors: pain catastrophizing
Measured with Pain Catastrophizing Scale (PCS). Minimum score is 0, maximum score is 52. The higher the score, the higher the pain catastrophizing.
Measured: 1 year postoperative
Psychosocial factors: illness perceptions
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Psychosocial factors: illness perceptions
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Psychosocial factors: illness perceptions
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Psychosocial factors: illness perceptions
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.
Measured: Baseline (preoperative)
Psychosocial factors: illness perceptions
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.
Measured: 3 months postoperative
Psychosocial factors: illness perceptions
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.
Measured: 1 year postoperative
Psychosocial factors: anxiety
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Psychosocial factors: anxiety
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Psychosocial factors: anxiety
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Psychosocial factors: anxiety
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.
Measured: Baseline (preoperative)
Psychosocial factors: anxiety
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.
Measured: 3 months postoperative
Psychosocial factors: anxiety
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.
Measured: 1 year postoperative
Psychosocial factors: depression
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Psychosocial factors: depression
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Psychosocial factors: depression
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Psychosocial factors: depression
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.
Measured: Baseline (preoperative)
Psychosocial factors: depression
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.
Measured: 3 months postoperative
Psychosocial factors: depression
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.
Measured: 1 year postoperative
Functional factors: Maximal voluntary muscle strength m. Hamstrings
Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Change from baseline (preoperative) to 3 months postoperative
Functional factors: Maximal voluntary muscle strength m. Hamstrings
Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Change from baseline (preoperative) to 1 year postoperative
Functional factors: Maximal voluntary muscle strength m. Hamstrings
Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Change from 3 months postoperative to 1 year postoperative
Functional factors: Maximal voluntary muscle strength m. Hamstrings
Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer
Measured: 3 months postoperative
Functional factors: Maximal voluntary muscle strength m. Hamstrings
Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Baseline (preoperative)
Functional factors: Maximal voluntary muscle strength m. Hamstrings
Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer
Measured: 1 year postoperative
Functional factors: Maximal voluntary muscle strength m. Quadriceps
Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Change from baseline (preoperative) to 3 months postoperative
Functional factors: Maximal voluntary muscle strength m. Quadriceps
Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Change from baseline (preoperative) to 1 year postoperative
Functional factors: Maximal voluntary muscle strength m. Quadriceps
Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Change from 3 months postoperative to 1 year postoperative
Functional factors: Maximal voluntary muscle strength m. Quadriceps
Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer
Measured: Baseline (preoperative)
Functional factors: Maximal voluntary muscle strength m. Quadriceps
Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer
Measured: 3 months postoperative
Functional factors: Maximal voluntary muscle strength m. Quadriceps
Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer
Measured: 1 year postoperative
Functional factors: proprioceptive accuracy
Proprioception of the knee of both legs, measured with inclinometer
Measured: Change from baseline (preoperative) to 3 months postoperative
Functional factors: proprioceptive accuracy
Proprioception of the knee of both legs, measured with inclinometer
Measured: Change from baseline (preoperative) to 1 year postoperative
Functional factors: proprioceptive accuracy
Proprioception of the knee of both legs, measured with inclinometer
Measured: Change from 3 months postoperative to 1 year postoperative
Functional factors: proprioceptive accuracy
Proprioception of the knee of both legs, measured with inclinometer
Measured: Baseline (preoperative)
Functional factors: proprioceptive accuracy
Proprioception of the knee of both legs, measured with inclinometer
Measured: 3 months postoperative
Functional factors: proprioceptive accuracy
Proprioception of the knee of both legs, measured with inclinometer
Measured: 1 year postoperative
Functional factors: leg strength and endurance
Measured with 30 seconds Timed Chair-Stand-Test
Measured: Change from baseline (preoperative) to 3 months postoperative
Functional factors: leg strength and endurance
Measured with 30 seconds Timed Chair-Stand-Test
Measured: Change from baseline (preoperative) to 1 year postoperative
Functional factors: leg strength and endurance
Measured with 30 seconds Timed Chair-Stand-Test
Measured: Change from 3 months postoperative to 1 year postoperative
Functional factors: leg strength and endurance
Measured with 30 seconds Timed Chair-Stand-Test
Measured: Baseline (preoperative)
Functional factors: leg strength and endurance
Measured with 30 seconds Timed Chair-Stand-Test
Measured: 3 months postoperative
Functional factors: leg strength and endurance
Measured with 30 seconds Timed Chair-Stand-Test
Measured: 1 year postoperative
Patient demographics
measured with Knee Society Scoring System (KSS): subscale patient demographics (nominal)
Measured: Baseline (preoperative)
Alignment
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.
Measured: Baseline (preoperative)
Instability
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.
Measured: Baseline (preoperative)
Joint motion
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.
Measured: Baseline (preoperative)
Pain symptoms
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Pain symptoms
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Pain symptoms
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Pain symptoms
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.
Measured: Baseline (preoperative)
Pain symptoms
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.
Measured: 3 months postoperative
Pain symptoms
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.
Measured: 1 year postoperative
Patient expectations
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
Measured: Baseline (preoperative)
Patient expectations fulfillment
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
Measured: 3 months postoperative
Patient expectations fulfillment
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
Measured: 1 year postoperative
Patient expectations fulfillment
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
Measured: Change from 3 months postoperative to 1 year postoperative
Patient satisfaction
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.
Measured: Change from baseline (preoperative) to 3 months postoperative
Patient satisfaction
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.
Measured: Change from baseline (preoperative) to 1 year postoperative
Patient satisfaction
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.
Measured: Change from 3 months postoperative to 1 year postoperative
Patient satisfaction
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.
Measured: Baseline (preoperative)
Patient satisfaction
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.
Measured: 3 months postoperative
Patient satisfaction
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.
Measured: 1 year postoperative
Functional score
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
Measured: Change from baseline (preoperative) to 3 months postoperative
Functional score
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
Measured: Change from baseline (preoperative) to 1 year postoperative
Functional score
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
Measured: Change from 3 months postoperative to 1 year postoperative
Functional score
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
Measured: Baseline (preoperative)
Functional score
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
Measured: 3 months postoperative
Functional score
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
Measured: 1 year postoperative
Metabolic factors: Fat mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Change from baseline (preoperative) to 3 months postoperative
Metabolic factors: Fat mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Change from baseline (preoperative) to 1 year postoperative
Metabolic factors: Fat mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Change from 3 months postoperative to 1 year postoperative
Metabolic factors: Fat mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Baseline (preoperative)
Metabolic factors: Fat mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: 3 months postoperative
Metabolic factors: Fat mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: 1 year postoperative
Metabolic factors: Lean mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Change from baseline (preoperative) to 3 months postoperative
Metabolic factors: Lean mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Change from baseline (preoperative) to 1 year postoperative
Metabolic factors: Lean mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Change from 3 months postoperative to 1 year postoperative
Metabolic factors: Lean mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: Baseline (preoperative)
Metabolic factors: Lean mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: 3 months postoperative
Metabolic factors: Lean mass
Measured with Bio-electrical Impedance Analyses (BIA)
Measured: 1 year postoperative
Metabolic factors: Body mass index (BMI)
Measured with length of patient (cm) and weight of patient (kg)
Measured: Change from baseline (preoperative) to 3 months postoperative
Metabolic factors: Body mass index (BMI)
Measured with length of patient (cm) and weight of patient (kg)
Measured: Change from baseline (preoperative) to 1 year postoperative
Metabolic factors: Body mass index (BMI)
Measured with length of patient (cm) and weight of patient (kg)
Measured: Change from 3 months postoperative to 1 year postoperative
Metabolic factors: Body mass index (BMI)
Measured with length of patient (cm) and weight of patient (kg)
Measured: Baseline (preoperative)
Metabolic factors: Body mass index (BMI)
Measured with length of patient (cm) and weight of patient (kg)
Measured: 3 months postoperative
Metabolic factors: Body mass index (BMI)
Measured with length of patient (cm) and weight of patient (kg)
Measured: 1 year postoperative
Metabolic factors: body composition
Measured with Bioelectrical Impedance Analysis (BIA)
Measured: Baseline (preoperative), 3 months postoperative, 1 year postoperative.
Metabolic factors: venous blood sample
Measured with A1C test or glycohemoglobin test
Measured: Change from baseline (preoperative) to 3 months postoperative
Metabolic factors: venous blood sample
Measured with A1C test or glycohemoglobin test
Measured: Change from baseline (preoperative) to 1 year postoperative
Metabolic factors: venous blood sample
Measured with A1C test or glycohemoglobin test
Measured: Change from 3 months postoperative to 1 year postoperative
Metabolic factors: venous blood sample
Measured with A1C test or glycohemoglobin test
Measured: Baseline (preoperative)
Metabolic factors: venous blood sample
Measured with A1C test or glycohemoglobin test
Measured: 3 months postoperative
Metabolic factors: venous blood sample
Measured with A1C test or glycohemoglobin test
Measured: 1 year postoperative.
Structural factors
Measured with Kellgren and Lawrence scale on radiography
Measured: Baseline (preoperative)
Inflammatory factors: signs of inflammation
Measured with the C-reactive protein levels in blood sample (collected from patient record)
Measured: Baseline (preoperative)
Anesthetic procedure
General anesthesia, spinal anesthesia or combination with peripheral block
Measured: During surgery
Clinical pain score
Measured with numeric rating pain scale
Measured: day 1 and 2 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start8 Mar 2018
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Vervullens, Universiteit Antwerpen
- Investigators
- Sophie Vervullens, Principal investigator, Universiteit AntwerpenLotte Meert, Principal investigator, Universiteit AntwerpenMira Meeus, Principal investigator, Universiteit AntwerpenIsabel Baert, Principal investigator, Universiteit AntwerpenRob J.E.M. Smeets, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380648
- Sponsor's protocol ID
- 13/47/472
- Status last verified
- Dec 2023
- First submitted
- 29 Apr 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vervullens S, Meert L, Smeets RJEM, van der Nest G, Verbrugghe J, Verdonk P, Rahusen FTG, Meeus M. A biopsychosocial approach to phenotyping people with knee osteoarthritis awaiting total knee arthroplasty: A secondary cohort analysis. Ann Phys Rehabil Med. 2024 Nov;67(8):101895. doi: 10.1016/j.rehab.2024.101895. Epub 2024 Oct 28.
PubMed 39489935Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, Baert I, Rahusen FTG, Heusdens CHW, Verdonk P, Meeus M. Preoperative glycaemic control, number of pain locations, structural knee damage, self-reported central sensitisation, satisfaction and personal control are predictive of 1-year postoperative pain, and change in pain from pre- to 1-year posttotal knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2025 Jan;33(1):201-219. doi: 10.1002/ksa.12265. Epub 2024 May 15.
PubMed 38751081Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, Verdonk P, Meeus M. Does pain intensity after total knee arthroplasty depend on somatosensory functioning in knee osteoarthritis patients? A prospective cohort study. Clin Rheumatol. 2024 Jun;43(6):2047-2059. doi: 10.1007/s10067-024-06976-7. Epub 2024 Apr 26.
PubMed 38668988
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05380648
- Acronym / sponsor ID
- 13/47/472
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Knee OA patients awaiting primary TKR surgery will be recruited at the University Hospital of Antwerp (BE), AZ Monica (BE), the academic hospital of Maastricht (NL) and St Jans Gasthuis Weert (NL). In each hospital, at least one orthopaedic surgeon already agreed to participate in this study and to recruit patients.
Key inclusion criteria (1 listed)
- Knee OA patients >40 years awaiting TKR surgery. Both men and women of all ethnical backgrounds are included.
Key exclusion criteria (3 listed)
- Patients with diagnosis of neurological/ systemic diseases, possibly impacting pain
- Patients who are not capable of understanding and speaking Dutch
- Revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyTotal knee arthroplasty surgery will be performed by different orthopedist. | Procedure or surgery | – |
Primary outcome
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.
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.
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.
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.
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.
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.
139 secondary outcomes
Central pain processing: mechanical local and widespread hyperalgesia allodynia
Time frame: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
Time frame: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
Time frame: Change from 3 months postoperative to 1 year postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
Time frame: Baseline (preoperative)
Central pain processing: mechanical local and widespread hyperalgesia allodynia
Time frame: 3 months postoperative
Central pain processing: mechanical local and widespread hyperalgesia allodynia
Time frame: 1 year postoperative
Central pain processing: bottom-up sensitization
Time frame: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: bottom-up sensitization
Time frame: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: bottom-up sensitization
Time frame: Change from 3 months postoperative to 1 year postoperative
Central pain processing: bottom-up sensitization
Time frame: Baseline (preoperative)
Central pain processing: bottom-up sensitization
Time frame: 3 months postoperative
Central pain processing: bottom-up sensitization
Time frame: 1 year postoperative
Central pain processing: Thermal hyperalgesia
Time frame: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: Thermal hyperalgesia
Time frame: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: Thermal hyperalgesia
Time frame: Change from 3 months postoperative to 1 year postoperative
Central pain processing: Thermal hyperalgesia
Time frame: Baseline (preoperative)
Central pain processing: Thermal hyperalgesia
Time frame: 3 months postoperative
Central pain processing: Thermal hyperalgesia
Time frame: 1 year postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Time frame: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Time frame: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Time frame: Change from 3 months postoperative to 1 year postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Time frame: Baseline (preoperative)
Central pain processing: dysfunctional endogenous pain analgesia
Time frame: 3 months postoperative
Central pain processing: dysfunctional endogenous pain analgesia
Time frame: 1 year postoperative
Central pain processing: somatic and emotional symptoms
Time frame: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: somatic and emotional symptoms
Time frame: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: somatic and emotional symptoms
Time frame: Change from 3 months postoperative to 1 year postoperative
Central pain processing: somatic and emotional symptoms
Time frame: Baseline (preoperative)
Central pain processing: somatic and emotional symptoms
Time frame: 3 months postoperative
Central pain processing: somatic and emotional symptoms
Time frame: 1 year postoperative
Central pain processing: areas of pain
Time frame: Change from baseline (preoperative) to 3 months postoperative
Central pain processing: areas of pain
Time frame: Change from baseline (preoperative) to 1 year postoperative
Central pain processing: areas of pain
Time frame: Change from 3 months postoperative to 1 year postoperative
Central pain processing: areas of pain
Time frame: Baseline (preoperative)
Central pain processing: areas of pain
Time frame: 3 months postoperative
Central pain processing: areas of pain
Time frame: 1 year postoperative
Psychosocial factors: pain catastrophizing
Time frame: Change from baseline (preoperative) to 3 months postoperative
Psychosocial factors: pain catastrophizing
Time frame: Change from baseline (preoperative) to 1 year postoperative
Psychosocial factors: pain catastrophizing
Time frame: Change from 3 months postoperative to 1 year postoperative
Psychosocial factors: pain catastrophizing
Time frame: Baseline (preoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Derived from this study: PubMed 39489935Vervullens S, Meert L, Smeets RJEM, van der Nest G, Verbrugghe J, Verdonk P, Rahusen FTG, Meeus M. A biopsychosocial approach to phenotyping people with knee osteoarthritis awaiting total knee arthroplasty: A secondary cohort analysis. Ann Phys Rehabil Med. 2024 Nov;67(8):101895. doi: 10.1016/j.rehab.2024.101895. Epub 2024 Oct 28.
- Derived from this study: PubMed 38751081Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, Baert I, Rahusen FTG, Heusdens CHW, Verdonk P, Meeus M. Preoperative glycaemic control, number of pain locations, structural knee damage, self-reported central sensitisation, satisfaction and personal control are predictive of 1-year postoperative pain, and change in pain from pre- to 1-year posttotal knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2025 Jan;33(1):201-219. doi: 10.1002/ksa.12265. Epub 2024 May 15.
- Derived from this study: PubMed 38668988Vervullens S, Meert L, Smeets RJEM, Verbrugghe J, Verdonk P, Meeus M. Does pain intensity after total knee arthroplasty depend on somatosensory functioning in knee osteoarthritis patients? A prospective cohort study. Clin Rheumatol. 2024 Jun;43(6):2047-2059. doi: 10.1007/s10067-024-06976-7. Epub 2024 Apr 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Vervullens principal investigator
Universiteit Antwerpen
Lotte Meert principal investigator
Universiteit Antwerpen
Mira Meeus principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Universiteit Antwerpen at 1 site in Belgium.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Dec 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity (time frame: Change from baseline pain intensity at 3 months postoperative). The study lists 6 primary outcomes in all. 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 NCT05380648, which also lists 3 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 29 Dec 2023.