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

Patient Satisfaction Clinical Trial

— SensorRCT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04775719
• Other study ID #: 10488
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

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.
• Standard Pre-Operative Total Knee Arthroplasty Information
Standard of care information that is routinely provided at patient preadmission appointments.

Locations

Country	Name	City	State
Canada	London Health Science Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local Knee Inflammation	Imaging and tissue biopsies to grade level of inflammation of the knee	Pre-operation and 1-year post-operation (imaging). Intra-operative (tissue biopsies)
Other	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Patient-reported questionnaire to assess pain, stiffness, and function.	Pre-operation and 1-year post-operation
Other	Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)	Patient-reported questionnaire to assess experience with constant and intermittent pain.	Pre-operation and 1-year post-operation
Other	Patient Global Assessment (PGA)	Patient-reported scale question to measure global disease activity on a range of 0 (doing very well) to 10 (doing very poorly)	Pre-operation and 1-year post-operation
Other	Global Rating of Change Scale (GROC)	Patient-reported questionnaire to assess self-perceived improvement.	Pre-operation and 1-year post-operation
Other	EuroQuol 5D (EQ-5D)	Patient-reported questionnaire to assess health-related quality of life and is used for economic analysis.	Pre-operation and 1-year post-operation
Other	UCLA Activity Score	Patient-reported questionnaire to assess activity from range of 1 (completely wholly inactive) to 10 (regularly participates in impact sports).	Pre-operation and 1-year post-operation
Primary	Patient Satisfaction	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).	Pre-operation, 3-months, and 1-year post-operation
Secondary	Cost Effectiveness	Patient-reported cost diary	At 2-weeks, 6-weeks, 3-months, and 1-year post-operation