Advanced Brain Imaging-TKA (fMRI-TKA)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

Knee replacement surgery is a common and effective treatment for pain and mobility loss, yet up to 1 in 5 patients remain dissatisfied after surgery due to ongoing pain or difficulty with daily activities. Currently, clinicians cannot reliably predict which patients will experience these challenges.

This study uses MRI scan of the brain to investigate whether specific patterns of brain activity can predict patient satisfaction after total knee arthroplasty (TKA). By comparing brain networks before surgery and afterward, and linking these changes to patient-reported pain and function, we aim to identify brain-based markers that can help predict outcomes, to improve satisfaction after knee replacement surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged 18 years or older

Primary TKA

Diagnosis of osteoarthritis, inflammatory arthritis, or osteonecrosis

Disqualifiers

Inability or refusal to sign informed consent form

Non-English or French speaking, and no licensed translator, family member or substitute decision maker available

History of major neurological disorders (e.g traumatic brain injury, epilepsy, multiple sclerosis

Cognitive impairment or dementia

Trial design

Design model

Single group

Treatments tested in this trial

  • fMRI Brain Scan

    Procedure/Surgery

    A research brain MRI scan will be performed on a 3T scanner. The MRI session will take approximately 50 minutes of scanning time. The MRI scan will be repeated again 2 months after surgery.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: fMRI Brain ScanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Preoperative Resting-State fMRI Brain connectivity as a Predictor of Patient operative Satisfaction after Total Knee Arthroplasty measured by Patient-Reported Outcomes Measurement Information System (PROMIS )

Using 50 pre-operative brain networks derived from advanced brain imaging will be assessed as predictors of postoperative patient satisfaction. Patient satisfaction measured by PROMIS questionnaire Preoperative resting-state fMRI brain connectivity will be assessed as a predictor of postoperative patient satisfaction measured using PROMIS questionnaires, which assess pain and function.

Time frame
Preoperative (Baseline)
2

Preoperative Resting-State fMRI Brain connectivity as a Predictor of Patient operative Satisfaction after Total Knee Arthroplasty measured by Oxford Knee Score (OKS)

Preoperative resting-state fMRI brain connectivity will be assessed as a predictor of postoperative patient satisfaction measured using the Oxford Knee Score, which assesses knee function and pain.

Time frame
Time Frame: Preoperative (Baseline)

Secondary outcomes

1

Longitudinal Change in Brain Network Connectivity from Preoperative to 12 months after total knee arthroplasty

50 brain networks derived from advanced brain imaging will be assessed longitudinally to characterize changes in brain networks from baseline to 12 months. Brain regions will be defined using the Schaefer functional atlas and the Allen Brain Atlas. Longitudinal changes in connectivity will be assessed using linear mixed-effects models with individual satisfaction change scores as continuous dependent variables. These models will include fixed effects for time and satisfaction, as well as random effects for subject ID to account for repeated measures. Changes will be computed by subtracting baseline from 12-month connectivity values, and these difference matrices will serve as the input features for modeling. The machine learning models for longitudinal change will follow the same 2:1 training/test split, k-fold cross-validation strategy, and performance evaluation.

Time frame
Pre-operative to 12-months Post-operative
2

Identification of Key Brain Network Nodes Associated with Postoperative Dissatisfaction after total knee arthroplasty

Brain network nodes will be identified from rsfMRI-derived brain networks that are associated with postoperative dissatisfaction. Network nodes will be analyzed to identify potential neuroimaging biomarkers relevant to postoperative outcomes and future therapeutic targeting. Nodes will be ranked based on their contribution to predictive models and graph-theoretical importance metrics.

Time frame
12 months postoperative

Other outcomes

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