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Recruiting NCT07464080

Advanced Brain Imaging-TKA (fMRI-TKA)

No phase Interventional Knee Osteoarthritis (Knee OA) Knee Pain Chronic Brain Network Connectivity Patient Satisfaction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fMRI Brain Scan.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis (Knee OA), Knee Pain Chronic, Brain Network Connectivity, Patient Satisfaction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • Longitudinal Change in Brain Network Connectivity from Preoperative to 12 months after total knee arthroplasty [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • The Ottawa Hospital — Ottawa

Identifiers

NCT: NCT07464080 · 20250620-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗