Recruiting

Brain Activity

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT07464080

Conditions

Knee Osteoarthritis (Knee OA)

Knee Pain Chronic

Brain Network Connectivity

Patient Satisfaction

Brain MRI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fMRI Brain Scan

Study Details

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

Study ID

NCT07464080

Start date

Apr 1, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: fMRI Brain Scan

Interventions

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.

Primary outcome measure

  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Sanjula Costa

613-737-8899scosta@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Sanjula Costa

613-737-8899scosta@ohri.ca

Principal Investigator:

Simon Garceau, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-03-11.