London Health Science Centre
London, Ontario, N6A5A5, Canada
NCT Number: NCT04775719
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
London, Ontario, N6A5A5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Information sheet that describes whether a patient is more likely to improve on or maintain their current preoperative function.
Standard of care information that is routinely provided at patient preadmission appointments.
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).
Time frame: At 2-weeks, 6-weeks, 3-months, and 1-year post-operation
Patient-reported cost diary
Time frame: Pre-operation and 1-year post-operation (imaging). Intra-operative (tissue biopsies)
Imaging and tissue biopsies to grade level of inflammation of the knee
Time frame: Pre-operation and 1-year post-operation
Patient-reported questionnaire to assess pain, stiffness, and function.
Time frame: Pre-operation and 1-year post-operation
Patient-reported questionnaire to assess experience with constant and intermittent pain.
Time frame: Pre-operation and 1-year post-operation
Patient-reported scale question to measure global disease activity on a range of 0 (doing very well) to 10 (doing very poorly)
Time frame: Pre-operation and 1-year post-operation
Patient-reported questionnaire to assess self-perceived improvement.
Time frame: Pre-operation and 1-year post-operation
Patient-reported questionnaire to assess health-related quality of life and is used for economic analysis.
Time frame: Pre-operation and 1-year post-operation
Patient-reported questionnaire to assess activity from range of 1 (completely wholly inactive) to 10 (regularly participates in impact sports).
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
Acronym: SensorRCT
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