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Active, Not Recruiting

NCT Number: NCT04775719

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Science Centre

London, Ontario, N6A5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-Specific Prediction of Functional Outcome

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

Other

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

Primary outcomes

  1. 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

  1. Cost Effectiveness

    Time frame: At 2-weeks, 6-weeks, 3-months, and 1-year post-operation

    Patient-reported cost diary

Other outcomes

  1. Local Knee Inflammation

    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

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Pre-operation and 1-year post-operation

    Patient-reported questionnaire to assess pain, stiffness, and function.

  3. Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)

    Time frame: Pre-operation and 1-year post-operation

    Patient-reported questionnaire to assess experience with constant and intermittent pain.

  4. Patient Global Assessment (PGA)

    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)

  5. Global Rating of Change Scale (GROC)

    Time frame: Pre-operation and 1-year post-operation

    Patient-reported questionnaire to assess self-perceived improvement.

  6. EuroQuol 5D (EQ-5D)

    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.

  7. UCLA Activity Score

    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).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: SensorRCT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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