1. To unravel which factors (altered CPP, structural, functional, metabolic, inflammatory and psychological factors measured presurgical) are predictive for an unsatisfactory outcome 1 year after a primary TKR (longitudinal).2. To unravel the…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The relation between altered CPP, structural, functional, metabolic and
psychological assessments (presurgery) and the subscore 'satisfaction' of the
new KSS questionnaire. The primary endpoint is at 1 year.
Secondary outcome
Central Pain Processing (CPP)
To identify localized and widespread sensitization, Quantitative Sensory
Testing (QST) along with the Central Sensitization Inventory (CSI) will be
used. QST incorporates measuring pain pressure threshold (PPT), thermal
hyperalgesia, temporal summation and conditioned pain modulation.
Structural measurement knee
A radiologist will determine the degree of osteoarthritis presurgical using a
Kellgren and Lawrence scale.
Functional measurements knee
Maximal voluntary muscle strength (isometric knee flexion and extension) will
be measured using a hand-held dynamometer.
Proprioceptive accuracy will be assessed presurgical and postsurgical measuring
the repositioning error during a knee joint position sense tests, using an
inclinometer.
Functionality will be measured using the 30 seconds chair stand test (30s-CST).
Subjectitve knee function will be measured by the Knee Society Knee Scoring
System
Metabolic factors
Patients* metabolic profile will be quantified by calculating the Body Mass
Index (BMI) and measuring the body composition using Bioelectrical Impedance
Analysis (BIA). In addition, a venous blood sample will be analysed with the
A1C test or glycohemoglobin test (Clover A1C Analyser). This A1C test provides
information about the average blood sugar (glucose) level in the past 3 months.
Inflammatory factors
Signs of inflammation will be evaluated by measuring C-Reactive Protein (CRP)
levels in a blood sample.
Psychological factors
Pain catastrophizing (Pain Catastrophizing Scale), the presence of anxiety and
depression (Hospital Anxiety and Depression scale) and illness perceptions
(Illness Perception Questionnaire) will be measured using questionnaires.
Background summary
Even though a Total Knee Replacement (TKR) is an effective surgical treatment
for end-stage knee osteoarthritis (OA) and the majority of patients report
substantial pain relief and functional improvement following this surgical
procedure, literature shows that 20-40% of patients are dissatisfied with the
postsurgical outcome. Similar to other chronic pain conditions, there is
growing body of research suggesting that in a subgroup of patients with KOA the
clinical picture is dominated by sensitization of central nervous system pain
pathways (i.e. central sensitization) rather than by structural dysfunctions
causing nociceptive pain. Briefly, this means that the pain is to a
considerable degree due to hypersensitivity of the central nervous system,
rather than being just caused by structural joint damage. Therefore, it is not
surprising that surgical interventions such as TKRs do not guarantee pain
reduction and functional recovery, as the pain goes beyond the joint.
In recent systematic reviews, several phenotypes have been proposed, such as
chronic pain-associated OA (in which altered CPP is dominant), OA associated
with joint-localized bone and cartilage metabolism and mechanical
load-associated OA. Other phenotypes that are proposed are metabolic
syndrome-associated OA and inflammation-associated OA. To what extent metabolic
and inflammatory factors are related to the clinical expression of OA and are
contributing to prognosis and treatment response is still open for debate, so
further research is warranted. It has been suggested that sustained
inflammatory stimuli and metabolic factors may drive peripheral and/or CS, but
this certainly needs further investigation.
Given the high costs related to TKR surgery and the substantial number of
patients who do not meet the level of improvement after surgery, the decision
to implant a TKR should be very well-considered. It is crucial to improve our
understanding of the mechanisms contributing to persisting pain and disability
following TKR and it emphasizes the need for further research on the role of
altered central pain processing and structural, functional, metabolic and
psychological factors in patients with end stage knee OA awaiting TKR surgery
Study objective
1. To unravel which factors (altered CPP, structural, functional, metabolic,
inflammatory and psychological factors measured presurgical) are predictive for
an unsatisfactory outcome 1 year after a primary TKR (longitudinal).
2. To unravel the interrelations between CPP, structural, functional,
metabolic, inflammatory and psychological factors before TKR surgery in
patients with knee OA (cross-sectional).
Study design
A longitudinal prospective study will be performed, with specific data
collection pre-surgical (T0) and 3 (T1) and 12 months (T2) post-surgical.
Study burden and risks
The risks of the measurements and questionnaires are negligible. The risks and
benefits regarding the TKP are separate from this study.
Universiteitsplein 1
Wilrijk 2610
BE
Universiteitsplein 1
Wilrijk 2610
BE
Listed location countries
Age
Inclusion criteria
Knee osteoarthritis patients > 40 years awaiting total knee replacement
surgery. Both men and women of all ethnic backgrounds are included.
Exclusion criteria
Patients with a neurological disorder or systemic disease possibly impacting
pain will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64654.068.18 |