Advanced Brain Imaging-TKA (fMRI-TKA) (fMRI-TKA)

March 9, 2026 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sanjula Costa
  • Phone Number: 72640 613-737-8899
  • Email: scosta@ohri.ca

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital
        • Principal Investigator:
          • Simon Garceau, MD
        • Contact:
          • Sanjula Costa
          • Phone Number: 72640 613-737-8899
          • Email: scosta@ohri.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: fMRI Brain Scan
Procedure: fMRI 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Preoperative (Baseline)
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.
Time Frame: Preoperative (Baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Pre-operative to 12-months Post-operative
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.
12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Garceau, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20250620-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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