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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 223
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Sophie Vervullens
Doctoral student Sophie Vervullens
Universiteit Antwerpen
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Central pain processing: bottom-up sensitization(1 year postoperative)
- Central pain processing: Thermal hyperalgesia(1 year postoperative)
- Central pain processing: dysfunctional endogenous pain analgesia(1 year postoperative)
- Central pain processing: areas of pain(1 year postoperative)
- Central pain processing: mechanical local and widespread hyperalgesia allodynia(1 year postoperative)
- Psychosocial factors: illness perceptions(1 year postoperative)
- Functional factors: Maximal voluntary muscle strength m. Quadriceps(1 year postoperative)
- Patient satisfaction(1 year postoperative)
- Functional factors: Maximal voluntary muscle strength m. Hamstrings(1 year postoperative)
- Functional factors: leg strength and endurance(1 year postoperative)
- Patient demographics(Baseline (preoperative))
- Alignment(Baseline (preoperative))
- Joint motion(Baseline (preoperative))
- Patient expectations fulfillment(Change from 3 months postoperative to 1 year postoperative)
- Metabolic factors: venous blood sample(1 year postoperative.)
- Inflammatory factors: signs of inflammation(Baseline (preoperative))
- Central pain processing: somatic and emotional symptoms(1 year postoperative)
- Psychosocial factors: pain catastrophizing(1 year postoperative)
- Pain symptoms(1 year postoperative)
- Patient expectations(Baseline (preoperative))
- Metabolic factors: Fat mass(1 year postoperative)
- Metabolic factors: Body mass index (BMI)(1 year postoperative)
- Psychosocial factors: anxiety(1 year postoperative)
- Metabolic factors: Lean mass(1 year postoperative)
- Instability(Baseline (preoperative))
- Psychosocial factors: depression(1 year postoperative)
- Functional factors: proprioceptive accuracy(1 year postoperative)
- Functional score(1 year postoperative)
- Metabolic factors: body composition(Baseline (preoperative), 3 months postoperative, 1 year postoperative.)
- Structural factors(Baseline (preoperative))
- Anesthetic procedure(During surgery)
- Clinical pain score(day 1 and 2 postoperative)