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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04775719
Acronym
SensorRCT
Enrollment
40
Registered
2021-03-01
Start date
2021-08-16
Completion date
2025-05-31
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Satisfaction

Keywords

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

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.

Interventions

OTHERPatient-Specific Prediction of Functional Outcome

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

OTHERStandard Pre-Operative Total Knee Arthroplasty Information

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

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient SatisfactionPre-operation, 3-months, and 1-year post-operationPatients 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

MeasureTime frameDescription
Cost EffectivenessAt 2-weeks, 6-weeks, 3-months, and 1-year post-operationPatient-reported cost diary

Other

MeasureTime frameDescription
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)Pre-operation and 1-year post-operationPatient-reported questionnaire to assess experience with constant and intermittent pain.
Patient Global Assessment (PGA)Pre-operation and 1-year post-operationPatient-reported scale question to measure global disease activity on a range of 0 (doing very well) to 10 (doing very poorly)
Local Knee InflammationPre-operation and 1-year post-operation (imaging). Intra-operative (tissue biopsies)Imaging and tissue biopsies to grade level of inflammation of the knee
EuroQuol 5D (EQ-5D)Pre-operation and 1-year post-operationPatient-reported questionnaire to assess health-related quality of life and is used for economic analysis.
UCLA Activity ScorePre-operation and 1-year post-operationPatient-reported questionnaire to assess activity from range of 1 (completely wholly inactive) to 10 (regularly participates in impact sports).
Global Rating of Change Scale (GROC)Pre-operation and 1-year post-operationPatient-reported questionnaire to assess self-perceived improvement.
Knee Injury and Osteoarthritis Outcome Score (KOOS)Pre-operation and 1-year post-operationPatient-reported questionnaire to assess pain, stiffness, and function.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026