Clinical trial NCT05380648: Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Arthroplasty, Replacement, Knee
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 223
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


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

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline pain intensity at 3 months postoperative
measure: Pain intensity
timeFrame: Change from baseline pain intensity at 1 year postoperative
measure: Pain intensity
timeFrame: Change from 3 months postoperative at 1 year postoperative
measure: Pain intensity
timeFrame: Baseline (preoperative)
measure: Pain intensity
timeFrame: 3 months postoperative
measure: Pain intensity
timeFrame: 1 year postoperative
Secondary outcomes:
measure: Central pain processing: mechanical local and widespread hyperalgesia allodynia
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Central pain processing: mechanical local and widespread hyperalgesia allodynia
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Central pain processing: mechanical local and widespread hyperalgesia allodynia
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Central pain processing: mechanical local and widespread hyperalgesia allodynia
timeFrame: Baseline (preoperative)
measure: Central pain processing: mechanical local and widespread hyperalgesia allodynia
timeFrame: 3 months postoperative
measure: Central pain processing: mechanical local and widespread hyperalgesia allodynia
timeFrame: 1 year postoperative
measure: Central pain processing: bottom-up sensitization
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Central pain processing: bottom-up sensitization
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Central pain processing: bottom-up sensitization
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Central pain processing: bottom-up sensitization
timeFrame: Baseline (preoperative)
measure: Central pain processing: bottom-up sensitization
timeFrame: 3 months postoperative
measure: Central pain processing: bottom-up sensitization
timeFrame: 1 year postoperative
measure: Central pain processing: Thermal hyperalgesia
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Central pain processing: Thermal hyperalgesia
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Central pain processing: Thermal hyperalgesia
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Central pain processing: Thermal hyperalgesia
timeFrame: Baseline (preoperative)
measure: Central pain processing: Thermal hyperalgesia
timeFrame: 3 months postoperative
measure: Central pain processing: Thermal hyperalgesia
timeFrame: 1 year postoperative
measure: Central pain processing: dysfunctional endogenous pain analgesia
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Central pain processing: dysfunctional endogenous pain analgesia
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Central pain processing: dysfunctional endogenous pain analgesia
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Central pain processing: dysfunctional endogenous pain analgesia
timeFrame: Baseline (preoperative)
measure: Central pain processing: dysfunctional endogenous pain analgesia
timeFrame: 3 months postoperative
measure: Central pain processing: dysfunctional endogenous pain analgesia
timeFrame: 1 year postoperative
measure: Central pain processing: somatic and emotional symptoms
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Central pain processing: somatic and emotional symptoms
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Central pain processing: somatic and emotional symptoms
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Central pain processing: somatic and emotional symptoms
timeFrame: Baseline (preoperative)
measure: Central pain processing: somatic and emotional symptoms
timeFrame: 3 months postoperative
measure: Central pain processing: somatic and emotional symptoms
timeFrame: 1 year postoperative
measure: Central pain processing: areas of pain
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Central pain processing: areas of pain
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Central pain processing: areas of pain
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Central pain processing: areas of pain
timeFrame: Baseline (preoperative)
measure: Central pain processing: areas of pain
timeFrame: 3 months postoperative
measure: Central pain processing: areas of pain
timeFrame: 1 year postoperative
measure: Psychosocial factors: pain catastrophizing
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Psychosocial factors: pain catastrophizing
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Psychosocial factors: pain catastrophizing
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Psychosocial factors: pain catastrophizing
timeFrame: Baseline (preoperative)
measure: Psychosocial factors: pain catastrophizing
timeFrame: 3 months postoperative
measure: Psychosocial factors: pain catastrophizing
timeFrame: 1 year postoperative
measure: Psychosocial factors: illness perceptions
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Psychosocial factors: illness perceptions
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Psychosocial factors: illness perceptions
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Psychosocial factors: illness perceptions
timeFrame: Baseline (preoperative)
measure: Psychosocial factors: illness perceptions
timeFrame: 3 months postoperative
measure: Psychosocial factors: illness perceptions
timeFrame: 1 year postoperative
measure: Psychosocial factors: anxiety
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Psychosocial factors: anxiety
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Psychosocial factors: anxiety
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Psychosocial factors: anxiety
timeFrame: Baseline (preoperative)
measure: Psychosocial factors: anxiety
timeFrame: 3 months postoperative
measure: Psychosocial factors: anxiety
timeFrame: 1 year postoperative
measure: Psychosocial factors: depression
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Psychosocial factors: depression
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Psychosocial factors: depression
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Psychosocial factors: depression
timeFrame: Baseline (preoperative)
measure: Psychosocial factors: depression
timeFrame: 3 months postoperative
measure: Psychosocial factors: depression
timeFrame: 1 year postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Hamstrings
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Hamstrings
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Hamstrings
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Hamstrings
timeFrame: 3 months postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Hamstrings
timeFrame: Baseline (preoperative)
measure: Functional factors: Maximal voluntary muscle strength m. Hamstrings
timeFrame: 1 year postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Quadriceps
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Quadriceps
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Quadriceps
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Quadriceps
timeFrame: Baseline (preoperative)
measure: Functional factors: Maximal voluntary muscle strength m. Quadriceps
timeFrame: 3 months postoperative
measure: Functional factors: Maximal voluntary muscle strength m. Quadriceps
timeFrame: 1 year postoperative
measure: Functional factors: proprioceptive accuracy
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Functional factors: proprioceptive accuracy
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Functional factors: proprioceptive accuracy
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Functional factors: proprioceptive accuracy
timeFrame: Baseline (preoperative)
measure: Functional factors: proprioceptive accuracy
timeFrame: 3 months postoperative
measure: Functional factors: proprioceptive accuracy
timeFrame: 1 year postoperative
measure: Functional factors: leg strength and endurance
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Functional factors: leg strength and endurance
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Functional factors: leg strength and endurance
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Functional factors: leg strength and endurance
timeFrame: Baseline (preoperative)
measure: Functional factors: leg strength and endurance
timeFrame: 3 months postoperative
measure: Functional factors: leg strength and endurance
timeFrame: 1 year postoperative
measure: Patient demographics
timeFrame: Baseline (preoperative)
measure: Alignment
timeFrame: Baseline (preoperative)
measure: Instability
timeFrame: Baseline (preoperative)
measure: Joint motion
timeFrame: Baseline (preoperative)
measure: Pain symptoms
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Pain symptoms
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Pain symptoms
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Pain symptoms
timeFrame: Baseline (preoperative)
measure: Pain symptoms
timeFrame: 3 months postoperative
measure: Pain symptoms
timeFrame: 1 year postoperative
measure: Patient expectations
timeFrame: Baseline (preoperative)
measure: Patient expectations fulfillment
timeFrame: 3 months postoperative
measure: Patient expectations fulfillment
timeFrame: 1 year postoperative
measure: Patient expectations fulfillment
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Patient satisfaction
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Patient satisfaction
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Patient satisfaction
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Patient satisfaction
timeFrame: Baseline (preoperative)
measure: Patient satisfaction
timeFrame: 3 months postoperative
measure: Patient satisfaction
timeFrame: 1 year postoperative
measure: Functional score
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Functional score
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Functional score
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Functional score
timeFrame: Baseline (preoperative)
measure: Functional score
timeFrame: 3 months postoperative
measure: Functional score
timeFrame: 1 year postoperative
measure: Metabolic factors: Fat mass
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Metabolic factors: Fat mass
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Metabolic factors: Fat mass
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Metabolic factors: Fat mass
timeFrame: Baseline (preoperative)
measure: Metabolic factors: Fat mass
timeFrame: 3 months postoperative
measure: Metabolic factors: Fat mass
timeFrame: 1 year postoperative
measure: Metabolic factors: Lean mass
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Metabolic factors: Lean mass
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Metabolic factors: Lean mass
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Metabolic factors: Lean mass
timeFrame: Baseline (preoperative)
measure: Metabolic factors: Lean mass
timeFrame: 3 months postoperative
measure: Metabolic factors: Lean mass
timeFrame: 1 year postoperative
measure: Metabolic factors: Body mass index (BMI)
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Metabolic factors: Body mass index (BMI)
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Metabolic factors: Body mass index (BMI)
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Metabolic factors: Body mass index (BMI)
timeFrame: Baseline (preoperative)
measure: Metabolic factors: Body mass index (BMI)
timeFrame: 3 months postoperative
measure: Metabolic factors: Body mass index (BMI)
timeFrame: 1 year postoperative
measure: Metabolic factors: body composition
timeFrame: Baseline (preoperative), 3 months postoperative, 1 year postoperative.
measure: Metabolic factors: venous blood sample
timeFrame: Change from baseline (preoperative) to 3 months postoperative
measure: Metabolic factors: venous blood sample
timeFrame: Change from baseline (preoperative) to 1 year postoperative
measure: Metabolic factors: venous blood sample
timeFrame: Change from 3 months postoperative to 1 year postoperative
measure: Metabolic factors: venous blood sample
timeFrame: Baseline (preoperative)
measure: Metabolic factors: venous blood sample
timeFrame: 3 months postoperative
measure: Metabolic factors: venous blood sample
timeFrame: 1 year postoperative.
measure: Structural factors
timeFrame: Baseline (preoperative)
measure: Inflammatory factors: signs of inflammation
timeFrame: Baseline (preoperative)
measure: Anesthetic procedure
timeFrame: During surgery
measure: Clinical pain score
timeFrame: day 1 and 2 postoperative
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Sophie Vervullens
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Lotte Meert
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Mira Meeus
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Isabel Baert
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Rob J.E.M. Smeets
role: PRINCIPAL_INVESTIGATOR
References: