Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07464080

Advanced Brain Imaging-TKA (fMRI-TKA)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location status: Recruiting

Location contact

Sanjula Costa

CONTACT

[email protected]

613-737-8899 ext. 72640

Simon Garceau, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients aged 18 years or older
  • Primary TKA
  • Diagnosis of osteoarthritis, inflammatory arthritis, or osteonecrosis

Exclusion criteria

  • 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
  • Revision and/or Bilateral TKA
  • Chronic Opioid use

Treatment and study plan

fMRI Brain Scan

Procedure

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.

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 )

    Time frame: 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.

  2. 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: 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 outcomes

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

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

    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.

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

    Time frame: 12 months postoperative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjula Costa

CONTACT

[email protected]

613-737-8899 ext. 72640

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: fMRI-TKA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.