Pilot Sensor Randomized Controlled Trial: Setting Expectations to Increase Satisfactory Outcomes After Total Knee Replacement

Study Overview
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Brief Summary
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More than 70,000 total knee replacement procedures are performed annually in Canada, representing a growth of 17% over the past 5 years, with further increases anticipated due to an aging population. While total knee replacement offers improved quality of life for patients and is cost effective for the healthcare system, 20% of patients routinely report dissatisfaction with the procedure. Patient dissatisfaction has been strongly linked to unmet expectations of outcomes after the surgery, especially with respect to physical activity. Counselling patients on appropriate expectations has been suggested as a means to improve satisfaction. Recently, our group has developed a tool to predict the functional ability of an individual patient after total knee replacement. This tool employs machine learning to classify patients as more likely to maintain or improve function, based on a functional test performed in clinic while wearing a sensor system around each knee. Implementing this tool in clinic pre-operatively could assist in setting appropriate expectations for each patient. Our primary objective is to compare patient satisfaction scores at one year after total knee replacement in patients who were informed of their specific expected functional outcome compared to patients who were not informed of their predicted functional outcome. We hypothesize that patients who are given an informed expectation will have higher satisfaction scores. This in turn may decrease health system costs associated with additional clinic visits from dissatisfied patients.

Official Title
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Pilot Sensor Randomized Controlled Trial: Setting Expectations to Increase Satisfactory Outcomes After Total Knee Replacement

Conditions
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Patient Satisfaction

Intervention / Treatment
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* Other: Patient-Specific Prediction of Functional Outcome
* Other: Standard Pre-Operative Total Knee Arthroplasty Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis scheduled to undergo primary total knee arthroplasty Exclusion Criteria: prior knee surgery inflammatory arthritis neuromuscular disorder that impairs gait scheduled for bilateral total knee arthroplasty Cannot read, write, or speak English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Outcome Prediction Group<br>Patient-Specific Prediction of Functional Outcome and Standard Pre-Operative Total Knee Arthroplasty Information | Other: Patient-Specific Prediction of Functional Outcome<br>* Information sheet that describes whether a patient is more likely to improve on or maintain their current preoperative function.<br>Other: Standard Pre-Operative Total Knee Arthroplasty Information<br>* Standard of care information that is routinely provided at patient preadmission appointments.<br>|
| Other: Standard Care Group<br>Standard Pre-Operative Total Knee Arthroplasty Information | Other: Standard Pre-Operative Total Knee Arthroplasty Information<br>* Standard of care information that is routinely provided at patient preadmission appointments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patients will complete the Knee Society Score (KSS) questionnaire. The primary outcome of interest from the KSS is the satisfaction section. There are five questions related to satisfaction, each with five options ranging from very dissatisfied (0 points) to very satisfied (8 points). | Pre-operation, 3-months, and 1-year post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Effectiveness | Patient-reported cost diary | At 2-weeks, 6-weeks, 3-months, and 1-year post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable Sensors, Machine Learning, Satisfaction, Expectations, Total Knee Arthroplasty