Arthroplasty, Replacement, Knee, Osteoarthritis, Knee
Conditions
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.
Interventions
PROCEDURETotal knee arthroplasty
Total knee arthroplasty surgery will be performed by different orthopedist.
Sponsors
Universiteit Antwerpen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient demographics | Baseline (preoperative) | measured with Knee Society Scoring System (KSS): subscale patient demographics (nominal) |
| Central pain processing: mechanical local and widespread hyperalgesia allodynia | 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. |
| Central pain processing: bottom-up sensitization | 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 |
| Central pain processing: Thermal hyperalgesia | 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. |
| Central pain processing: dysfunctional endogenous pain analgesia | Change from baseline (preoperative) to 3 months postoperative | Measured with quantitative sensory testing (QST): conditioned pain modulation measured Medoc at both wrists |
| Central pain processing: somatic and emotional symptoms | 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. |
| Central pain processing: areas of pain | 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 |
| Psychosocial factors: pain catastrophizing | 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. |
| Psychosocial factors: illness perceptions | Change from baseline (preoperative) to 3 months 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. |
| Psychosocial factors: anxiety | 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. |
| Psychosocial factors: depression | 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. |
| Functional factors: Maximal voluntary muscle strength m. Hamstrings | Change from baseline (preoperative) to 3 months postoperative | Strength m. Hamstrings of both legs, measured with Biodex System 4 pro - dynamometer |
| Functional factors: Maximal voluntary muscle strength m. Quadriceps | Change from baseline (preoperative) to 3 months postoperative | Strength m. Quadriceps of both legs, measured with Biodex System 4 pro - dynamometer |
| Functional factors: proprioceptive accuracy | Change from baseline (preoperative) to 3 months postoperative | Proprioception of the knee of both legs, measured with inclinometer |
| 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. |
| Functional factors: leg strength and endurance | Change from baseline (preoperative) to 3 months postoperative | Measured with 30 seconds Timed Chair-Stand-Test |
| 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. |
| Pain symptoms | 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. |
| 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 |
| Patient expectations fulfillment | 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 |
| Patient satisfaction | 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. |
| Functional score | 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 |
| Metabolic factors: Fat mass | Change from baseline (preoperative) to 3 months postoperative | Measured with Bio-electrical Impedance Analyses (BIA) |
| Metabolic factors: Lean mass | Change from baseline (preoperative) to 3 months postoperative | Measured with Bio-electrical Impedance Analyses (BIA) |
| Metabolic factors: Body mass index (BMI) | Change from baseline (preoperative) to 3 months postoperative | Measured with length of patient (cm) and weight of patient (kg) |
| Metabolic factors: body composition | Baseline (preoperative), 3 months postoperative, 1 year postoperative. | Measured with Bioelectrical Impedance Analysis (BIA) |
| Metabolic factors: venous blood sample | Change from baseline (preoperative) to 3 months postoperative | Measured with A1C test or glycohemoglobin test |
| Structural factors | Baseline (preoperative) | Measured with Kellgren and Lawrence scale on radiography |
| Inflammatory factors: signs of inflammation | Baseline (preoperative) | Measured with the C-reactive protein levels in blood sample (collected from patient record) |
| 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 |
| 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. |
Countries
Belgium
Outcome results
None listed