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

NCT04775719 | Active Not Recruiting

• 1 other identifier: 10488
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Satisfaction

Keywords

Wearable Sensors; Machine Learning; Satisfaction; Expectations; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost Effectiveness

  At 2-weeks, 6-weeks, 3-months, and 1-year post-operation

Other Outcomes (7)

• Local Knee Inflammation

  Pre-operation and 1-year post-operation (imaging). Intra-operative (tissue biopsies)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Pre-operation and 1-year post-operation

• Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)

  Pre-operation and 1-year post-operation

Study Arms (2)

Outcome Prediction Group

OTHER

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

Other: Patient-Specific Prediction of Functional Outcome; Other: Standard Pre-Operative Total Knee Arthroplasty Information

Standard Care Group

OTHER

Standard Pre-Operative Total Knee Arthroplasty Information

Other: Standard Pre-Operative Total Knee Arthroplasty Information

Interventions

Patient-Specific Prediction of Functional Outcome OTHER

Information sheet that describes whether a patient is more likely to improve on or maintain their current preoperative function.

Outcome Prediction Group

Standard Pre-Operative Total Knee Arthroplasty Information OTHER

Standard of care information that is routinely provided at patient preadmission appointments.

Outcome Prediction Group; Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with osteoarthritis scheduled to undergo primary total knee arthroplasty

You may not qualify if:

• prior knee surgery
• inflammatory arthritis
• neuromuscular disorder that impairs gait
• scheduled for bilateral total knee arthroplasty
• Cannot read, write, or speak English

Sponsors & Collaborators

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

Study Sites (1)

London Health Science Centre

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Patient Satisfaction; Personal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Brent Lanting

  Lawson Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Members of the care team and investigator will be blinded from knowing which study arm the patient is in and what their predicted functional ability is, to ensure standard of care is not influenced in any way.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: March 1, 2021
• Study Start: August 16, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)