Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis
- Conditions
- Osteoarthritis, KneeArthroplasty, Replacement, Knee
- Registration Number
- NCT05380648
- Lead Sponsor
- Universiteit Antwerpen
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 223
- Knee OA patients >40 years awaiting TKR surgery. Both men and women of all ethnical backgrounds are included.
- Patients with diagnosis of neurological/ systemic diseases, possibly impacting pain
- Patients who are not capable of understanding and speaking Dutch
- Revision surgery
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity 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 Outcome Measures
Name Time Method Central pain processing: mechanical local and widespread hyperalgesia allodynia 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.
Psychosocial factors: illness perceptions 1 year postoperative Illness perception questionnaire-revised (IPQ-R)
1. Identity dimension:
yes = 1; no = 0 min score= 0, max score= 18
2. Other dimensions:
min score= 38, max score= 190 strongly disagree =1, disagree =2, neither agree or disagree = 3, agree = 4, strongly agree = 5
3. 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.Functional factors: Maximal voluntary muscle strength m. Quadriceps 1 year postoperative Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer
Patient satisfaction 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.
Patient demographics Baseline (preoperative) measured with Knee Society Scoring System (KSS): subscale patient demographics (nominal)
Alignment 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.
Joint motion 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.
Patient expectations fulfillment 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
Metabolic factors: venous blood sample 1 year postoperative. Measured with A1C test or glycohemoglobin test
Inflammatory factors: signs of inflammation Baseline (preoperative) Measured with the C-reactive protein levels in blood sample (collected from patient record)
Central pain processing: somatic and emotional symptoms 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.
Psychosocial factors: pain catastrophizing 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.
Functional factors: Maximal voluntary muscle strength m. Hamstrings 1 year postoperative Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer
Functional factors: leg strength and endurance 1 year postoperative Measured with 30 seconds Timed Chair-Stand-Test
Pain symptoms 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.
Patient expectations 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
Metabolic factors: Fat mass 1 year postoperative Measured with Bio-electrical Impedance Analyses (BIA)
Metabolic factors: Body mass index (BMI) 1 year postoperative Measured with length of patient (cm) and weight of patient (kg)
Psychosocial factors: anxiety 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.
Metabolic factors: Lean mass 1 year postoperative Measured with Bio-electrical Impedance Analyses (BIA)
Psychosocial factors: depression 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.
Functional factors: proprioceptive accuracy 1 year postoperative Proprioception of the knee of both legs, measured with inclinometer
Instability 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.
Functional score 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
Metabolic factors: body composition Baseline (preoperative), 3 months postoperative, 1 year postoperative. Measured with Bioelectrical Impedance Analysis (BIA)
Structural factors Baseline (preoperative) Measured with Kellgren and Lawrence scale on radiography
Anesthetic procedure During surgery General anesthesia, spinal anesthesia or combination with peripheral block
Clinical pain score day 1 and 2 postoperative Measured with numeric rating pain scale
Central pain processing: bottom-up sensitization 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
Central pain processing: Thermal hyperalgesia 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.
Central pain processing: dysfunctional endogenous pain analgesia 1 year postoperative Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists
Central pain processing: areas of pain 1 year postoperative Body chart: Expanded distribution of Pain (EDP). The more pain locations, the more chance for the presence of central sensitization
Trial Locations
- Locations (1)
University of Antwerp
🇧🇪Antwerp, Belgium