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Advanced Brain Imaging-TKA (fMRI-TKA)

Brain Network-based Precision Medicine to Predict Dissatisfaction Following Total Knee Arthroplasty

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07464080
Acronym
fMRI-TKA
Enrollment
50
Registered
2026-03-11
Start date
2026-04-01
Completion date
2028-12-31
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain MRI, Brain Network Connectivity, Knee Osteoarthritis (Knee OA), Knee Pain Chronic, Patient Satisfaction

Brief summary

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.

Interventions

PROCEDUREfMRI Brain Scan

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.

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male and female patients aged 18 years or older 2. Primary TKA 3. Diagnosis of osteoarthritis, inflammatory arthritis, or osteonecrosis

Exclusion criteria

1. Inability or refusal to sign informed consent form 2. Non-English or French speaking, and no licensed translator, family member or substitute decision maker available 3. History of major neurological disorders (e.g traumatic brain injury, epilepsy, multiple sclerosis 4. Cognitive impairment or dementia 5. Revision and/or Bilateral TKA 6. Chronic Opioid use

Design outcomes

Primary

MeasureTime frameDescription
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 )Preoperative (Baseline)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.
Preoperative Resting-State fMRI Brain connectivity as a Predictor of Patient operative Satisfaction after Total Knee Arthroplasty measured by Oxford Knee Score (OKS)Time Frame: Preoperative (Baseline)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.

Secondary

MeasureTime frameDescription
Longitudinal Change in Brain Network Connectivity from Preoperative to 12 months after total knee arthroplastyPre-operative to 12-months Post-operative50 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.
Identification of Key Brain Network Nodes Associated with Postoperative Dissatisfaction after total knee arthroplasty12 months postoperativeBrain 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.

Countries

Canada

Contacts

CONTACTSanjula Costa
scosta@ohri.ca613-737-8899
PRINCIPAL_INVESTIGATORSimon Garceau

The Ottawa Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026