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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2025-05-31

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.

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Detailed Description

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Conditions

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Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

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.

Study Groups

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Outcome Prediction Group

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

Group Type OTHER

Patient-Specific Prediction of Functional Outcome

Intervention Type OTHER

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

Standard Pre-Operative Total Knee Arthroplasty Information

Intervention Type OTHER

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

Standard Care Group

Standard Pre-Operative Total Knee Arthroplasty Information

Group Type OTHER

Standard Pre-Operative Total Knee Arthroplasty Information

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Standard Pre-Operative Total Knee Arthroplasty Information

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No