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Clinical Trials/NCT04775719
NCT04775719
Active, Not Recruiting
N/A

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

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's1 site in 1 country40 target enrollmentAugust 16, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Patient Satisfaction
Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Enrollment
40
Locations
1
Primary Endpoint
Patient Satisfaction
Status
Active, Not Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 16, 2021
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Patient Satisfaction

Time Frame: Pre-operation, 3-months, and 1-year post-operation

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).

Secondary Outcomes

  • Cost Effectiveness(At 2-weeks, 6-weeks, 3-months, and 1-year post-operation)

Study Sites (1)

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