Pilot Sensor Randomized Controlled Trial: Setting Expectations to Increase Satisfactory Outcomes After Total Knee Replacement
- Conditions
- Patient Satisfaction
- Interventions
- Other: Patient-Specific Prediction of Functional OutcomeOther: Standard Pre-Operative Total Knee Arthroplasty Information
- Registration Number
- NCT04775719
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patients with osteoarthritis scheduled to undergo primary total knee arthroplasty
- prior knee surgery
- inflammatory arthritis
- neuromuscular disorder that impairs gait
- scheduled for bilateral total knee arthroplasty
- Cannot read, write, or speak English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Outcome Prediction Group Standard Pre-Operative Total Knee Arthroplasty Information Patient-Specific Prediction of Functional Outcome and Standard Pre-Operative Total Knee Arthroplasty Information Standard Care Group Standard Pre-Operative Total Knee Arthroplasty Information Standard Pre-Operative Total Knee Arthroplasty Information Outcome Prediction Group Patient-Specific Prediction of Functional Outcome Patient-Specific Prediction of Functional Outcome and Standard Pre-Operative Total Knee Arthroplasty Information
- Primary Outcome Measures
Name Time Method 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
Name Time Method Cost Effectiveness At 2-weeks, 6-weeks, 3-months, and 1-year post-operation Patient-reported cost diary
Trial Locations
- Locations (1)
London Health Science Centre
🇨🇦London, Ontario, Canada