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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04775719

Collaborator

(none)

Enrollment

Location

Arms

28.5

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Other: Patient-Specific Prediction of Functional Outcome Other: Standard Pre-Operative Total Knee Arthroplasty Information	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, 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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 16, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Outcome Prediction Group Patient-Specific Prediction of Functional Outcome and Standard Pre-Operative Total Knee Arthroplasty Information	Other: Patient-Specific Prediction of Functional Outcome Information sheet that describes whether a patient is more likely to improve on or maintain their current preoperative function. Other: Standard Pre-Operative Total Knee Arthroplasty Information Standard of care information that is routinely provided at patient preadmission appointments.
Other: Standard Care Group Standard Pre-Operative Total Knee Arthroplasty Information	Other: Standard Pre-Operative Total Knee Arthroplasty Information Standard of care information that is routinely provided at patient preadmission appointments.

Arm

Intervention/Treatment

Other: Outcome Prediction Group

Patient-Specific Prediction of Functional Outcome and Standard Pre-Operative Total Knee Arthroplasty Information

Other: Patient-Specific Prediction of Functional Outcome

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

Other: Standard Pre-Operative Total Knee Arthroplasty Information

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

Other: Standard Care Group

Standard Pre-Operative Total Knee Arthroplasty Information

Other: Standard Pre-Operative Total Knee Arthroplasty Information

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

Outcome Measures

Primary Outcome Measures

Patient Satisfaction [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 Outcome Measures

Cost Effectiveness [At 2-weeks, 6-weeks, 3-months, and 1-year post-operation]
Patient-reported cost diary

Other Outcome Measures

Local Knee Inflammation [Pre-operation and 1-year post-operation (imaging). Intra-operative (tissue biopsies)]
Imaging and tissue biopsies to grade level of inflammation of the knee
Knee Injury and Osteoarthritis Outcome Score (KOOS) [Pre-operation and 1-year post-operation]
Patient-reported questionnaire to assess pain, stiffness, and function.
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) [Pre-operation and 1-year post-operation]
Patient-reported questionnaire to assess experience with constant and intermittent pain.
Patient Global Assessment (PGA) [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)
Global Rating of Change Scale (GROC) [Pre-operation and 1-year post-operation]
Patient-reported questionnaire to assess self-perceived improvement.
EuroQuol 5D (EQ-5D) [Pre-operation and 1-year post-operation]
Patient-reported questionnaire to assess health-related quality of life and is used for economic analysis.
UCLA Activity Score [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London Health Science Centre	London	Ontario	Canada	N6A5A5

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator: Brent Lanting, Lawson Health Science Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT04775719

Other Study ID Numbers:

10488

First Posted:

Mar 1, 2021

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lawson Health Research Institute

Total Knee Arthroplasty

Study Results

No Results Posted as of Feb 11, 2022