Advanced Brain Imaging-TKA (fMRI-TKA)

NCT07464080 | Recruiting

• 1 other identifier: 20250620-01H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  Pre-operative to 12-months Post-operative

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

  12 months postoperative

Study Arms (1)

fMRI Brain Scan

EXPERIMENTAL

Procedure: fMRI Brain Scan

Interventions

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.

fMRI Brain Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Patient Satisfaction

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Simon Garceau

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjula Costa

CONTACT

613-737-8899; scosta@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)