Patient-Specific Predictions for Post-Knee Replacement Satisfaction

(SensorRCT Trial)

Overseen By Brent Lanting

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Disqualifiers: Prior knee surgery, Inflammatory arthritis, Neuromuscular disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if informing patients about their likely post-surgery function increases satisfaction after knee replacement surgery. It employs a new tool that predicts post-surgery mobility. The trial compares satisfaction between patients who receive this personalized prediction and those who do not. Individuals with osteoarthritis scheduled for their first knee replacement, without other specific health issues, are suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance patient satisfaction after surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prediction tool is safe for use in pre-operative settings?

Research shows that tools predicting outcomes after knee replacement surgery are generally safe. Studies have found that these tools help patients set realistic expectations, leading to greater satisfaction. No reports indicate harmful effects from using these prediction tools.

The aim is to give patients a clearer idea of what to expect after surgery by using data from sensors and machine learning. This approach is designed to enhance patient satisfaction with their recovery. Research has focused on ensuring these predictions are accurate and helpful, without causing harm.

This trial focuses on using the prediction tool to improve satisfaction after knee surgery. It is not a medical treatment or drug, so it doesn't carry the same risks or side effects. Overall, the prediction tool is considered safe and serves as a means to provide better information to patients before their surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial focusing on patient-specific predictions for post-knee replacement satisfaction because it aims to personalize patient care. Unlike standard pre-operative information, this approach uses tailored predictions to better forecast how patients might feel and function after surgery. This could lead to more informed decision-making for both doctors and patients, potentially improving satisfaction and outcomes by setting realistic, individualized expectations. By shifting from a one-size-fits-all model to a personalized prediction model, this trial could revolutionize how we approach knee replacement surgeries.

What evidence suggests that this tool is effective for improving post-knee replacement satisfaction?

Research has shown that about 20% of patients who undergo total knee replacement surgery are dissatisfied with the results. This dissatisfaction often stems from unrealistic expectations about post-surgery capabilities. In this trial, participants in the Outcome Prediction Group will receive a new tool that uses advanced technology to predict post-surgery movement and function. This tool aims to set more realistic expectations, potentially leading to greater satisfaction. By offering patients a clearer idea of what to expect, the researchers hope for improved satisfaction with surgery outcomes. Meanwhile, participants in the Standard Care Group will receive standard pre-operative information. ^{3 6 7 8 9}

Who Is on the Research Team?

Brent Lanting, MD

Principal Investigator

Lawson Health Science Centre

Are You a Good Fit for This Trial?

This trial is for patients with osteoarthritis who are scheduled for a primary total knee replacement. It's not suitable for those getting both knees replaced at once, individuals who can't read, write or speak English, or have conditions affecting their walk or previous knee surgeries.

Inclusion Criteria

I am scheduled for a first-time knee replacement due to osteoarthritis.

Exclusion Criteria

I have a history of inflammatory arthritis.

I have a muscle or nerve condition that affects my ability to walk.

I am scheduled for surgery to replace both of my knees.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments including functional tests with a sensor system to set expectations

1-2 weeks

1 visit (in-person)

Surgery and Immediate Post-operative Care

Participants undergo total knee replacement surgery and receive immediate post-operative care

1 week

In-patient stay

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments at 2 weeks, 6 weeks, 3 months, and 1 year post-operation

1 year

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Patient-Specific Prediction of Functional Outcome
• Standard Pre-Operative Total Knee Arthroplasty Information

Trial Overview The study tests if knowing the predicted outcome of knee surgery improves patient satisfaction. One group will receive standard pre-op info while the other will also get predictions on their post-surgery function based on a sensor test and machine learning.

How Is the Trial Designed?

Group I: Standard Care Group Experimental Treatment 1 Intervention

Standard Pre-Operative Total Knee Arthroplasty Information

Group II: Outcome Prediction Group Experimental Treatment 2 Interventions

Patient-Specific Prediction of Functional Outcome and Standard Pre-Operative Total Knee Arthroplasty Information

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2795819/

Patient Satisfaction after Total Knee Arthroplasty Despite substantial advances in primary TKA, numerous studies using historic TKA implants suggest only 82% to 89% of primary TKA patients are satisfied.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10111922/

Patient appropriateness for total knee arthroplasty and ... While, on average, TKA is highly effective, 15%–30% of recipients report little or no symptom improvement and/or dissatisfaction with results.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540316302698

A New Prediction Model for Patient Satisfaction After Total ... Overall satisfaction rate in this study was found to be 88%. We identified a significant difference between the satisfied and dissatisfied group when looking at ...

4. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-021-02469-4

A new prediction model for patient satisfaction after total knee ... Despite its widespread use and popularity, several studies have reported that ~20% of patients are dissatisfied with the outcomes of primary TKA ...

5. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/personalized-outcome-prediction-of-pain-and-functional-changes-following-total-knee-arthroplasty

Personalized Outcome Prediction of Pain and Functional ... This tool provides a visual display of the patient's predicted outcomes of their surgery, which is easily interpreted.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12344954/

Predicting Outcome One Year After Knee Arthroplasty - PMC Data were collected from patients undergoing primary knee arthroplasty for primary osteoarthritis recruited to the Evaluation of perioperative ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10583907/

Prediction of early functional outcomes in patients after ... This study aimed to develop a nomogram model to predict the likelihood of achieving a beneficial functional outcome.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540324009999

Predicting Outcome of Total Knee Arthroplasty by Cluster ... Total knee arthroplasties (TKAs) exhibit an 8 to 30% risk of suboptimal outcomes, resulting in persistent symptoms, individual morbidity, and revision ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794125

Factors Correlated With Physical Function 1 Year After ... Importance More than 1 in 5 patients do not experience improved physical function after total knee arthroplasty (TKA).