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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Patient-Specific Prediction of Functional Outcome; Other: Standard Pre-Operative Total Knee Arthroplasty Information

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • London Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Knee Inflammation	Imaging and tissue biopsies to grade level of inflammation of the knee	Pre-operation and 1-year post-operation (imaging). Intra-operative (tissue biopsies)
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient-reported questionnaire to assess pain, stiffness, and function.	Pre-operation and 1-year post-operation
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)	Patient-reported questionnaire to assess experience with constant and intermittent pain.	Pre-operation and 1-year post-operation
Patient Global Assessment (PGA)	Patient-reported scale question to measure global disease activity on a range of 0 (doing very well) to 10 (doing very poorly)	Pre-operation and 1-year post-operation
Global Rating of Change Scale (GROC)	Patient-reported questionnaire to assess self-perceived improvement.	Pre-operation and 1-year post-operation
EuroQuol 5D (EQ-5D)	Patient-reported questionnaire to assess health-related quality of life and is used for economic analysis.	Pre-operation and 1-year post-operation
UCLA Activity Score	Patient-reported questionnaire to assess activity from range of 1 (completely wholly inactive) to 10 (regularly participates in impact sports).	Pre-operation and 1-year post-operation

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Brent Lanting, Lawson Health Science Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Satisfaction; Total Knee Arthroplasty; Expectations; Wearable Sensors; Machine Learning
• Other Study ID Numbers: 10488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No