Clinical trial NCT04775719: Pilot Sensor Randomized Controlled Trial: Setting Expectations to Increase Satisfactory Outcomes After Total Knee Replacement
Official title: Pilot Sensor Randomized Controlled Trial: Setting Expectations to Increase Satisfactory Outcomes After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Keywords: Wearable Sensors
Machine Learning
Satisfaction
Expectations
Total Knee Arthroplasty
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Pre-operation, 3-months, and 1-year post-operation
Secondary outcomes:
measure: Cost Effectiveness
timeFrame: At 2-weeks, 6-weeks, 3-months, and 1-year post-operation
Other outcomes:
measure: Local Knee Inflammation
timeFrame: Pre-operation and 1-year post-operation (imaging). Intra-operative (tissue biopsies)
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Pre-operation and 1-year post-operation
measure: Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
timeFrame: Pre-operation and 1-year post-operation
measure: Patient Global Assessment (PGA)
timeFrame: Pre-operation and 1-year post-operation
measure: Global Rating of Change Scale (GROC)
timeFrame: Pre-operation and 1-year post-operation
measure: EuroQuol 5D (EQ-5D)
timeFrame: Pre-operation and 1-year post-operation
measure: UCLA Activity Score
timeFrame: Pre-operation and 1-year post-operation
Locations:
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
Study officials:
affiliation: Lawson Health Science Centre
name: Brent Lanting
role: PRINCIPAL_INVESTIGATOR
References: