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

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: Recruiting
• Conditions: Patient Satisfaction; Knee Pain Chronic; Knee Osteoarthritis (Knee OA); Brain MRI; Brain Network Connectivity
• Intervention / Treatment: Procedure: fMRI Brain Scan

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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 )	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)	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

Outcome Measure	Measure Description	Time Frame
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.	Pre-operative to 12-months Post-operative
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.	12 months postoperative

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Simon Garceau, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 28, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Behavior; Treatment Adherence and Compliance; Health Behavior; Osteoarthritis, Knee; Patient Satisfaction
• Other Study ID 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