Knee Connect: Measuring Range of Motion and Gait Metrics After Total Knee Arthroplasty

Study Overview
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Brief Summary
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The main goals of total knee replacement (TKR) surgery are to relieve pain and to allow patients to remain active. Sunnybrook is working with Kineris Inc.to advance a wearable device, the Knee Connect, aimed at tracking the physical recovery of patients after total knee replacements. After surgery, patients experience a gradual progression in function as their knee range of motion (ROM) increases and their gait patterns normalize. Goals for these metrics are well documented after the patient is fully recovered. However, there is a lack of detailed information available about the week by week improvements patients make in these metrics. The main objective of this study is to determine the accuracy of the Knee Connect device in quantifying the weekly improvements in ROM and gait parameters of patients recovering from surgery.

Detailed Description
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A research assistant will conduct in person data collections on 36 patients using the Kineris wearable device. The device is an electronic goniometer connected to a smart phone application. Patients will be recruited from the Patient Orientation Program (POP) at the Sunnybrook Holland Centre. Data collection will occur preoperatively, at the end of each physiotherapy Knee Class session, and at the three month postoperative clinic visit. The research assistant will help fit and attach the wearable device to each patient's knee. Patients will be asked to bend their knee (flexion and extension) while wearing the device which will measure patients range of motion. The research assistant will also measure knee range of motion using a handheld protractor. Afterward, patients will be asked to walk 10 steps, using any walking aids or techniques they typically use at home. There will be 15 collections per patient requiring ten minutes per session. Chart reviews will also be conducted to determine patient reported outcomes which will be then correlated with the functional measures. All data will be extracted and input into an excel file. For both the ROM tests, the accuracy of the Knee Connect device will be compared against the plastic goniometer. This will be done by using a paired t-test and calculating interclass correlation coefficient. The data will then be analyzed using a repeated measures ANOVA and Bonferroni post-hoc analysis to determine differences in the variables week to week. Additionally, a regression analysis will be used to estimate the week by week improvements in these variables.

Official Title
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Knee Connect: Measuring Range of Motion and Gait Metrics After Total Knee Arthroplasty

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Knee Connect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be currently on the waiting list for a primary TKR Be enrolled for the Knee Class postoperative physiotherapy at the Sunnybrook Holland Centre with the expectation of attending the class through the duration of the class. Be able to provide informed consent. Exclusion Criteria: Revision total knee arthroplasty Neuromuscular disorder Bilateral TKR procedures
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TKR Patients<br>Any patient undergoing total knee arthroplasty and will use the Knee Connect during their knee classes at the Holland Centre | Device: Knee Connect<br>* An electronic goniometer with smart phone application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Range of Motion Error | The difference in measured knee range of motion (in degrees) between the Knee Connect and the handheld goniometer. Completed at each study time point (listed below) in order to gather as much data on the accuracy of knee connect compared to the goniometer. | One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee range of motion | The weekly knee range of motion (in degrees) measured by the Knee Connect | One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit | 
| Stride Time | The weekly gait stride time (in seconds) measured by the Knee Connect | One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit | 
| Stance Range of Motion | The weekly gait stance range of motion (in degrees) measured by the Knee Connect | One pre-operative, one during inpatient stay, 12 during knee class visits, one during 3 month clinic visit | 
| Swing Range of Motion | The weekly gait swing range of motion (in degrees) measured by the Knee Connect | One reading 2-4 weeks pre-operation, two readings weekly for 2-6 weeks post-operation (during physiotherapy knee class visits), one during 3 month post-operative clinic visit | 
| Western Ontario and McMaster Universities Osteoarthritis Index | Western Ontario and McMaster Universities Osteoarthritis Index function sub-scale and total score Sub scales: Pain (5 items, each rated on a scale from 0-4); Joint stiffness (2 items, each rated on a scale from 0-4), Physical function (17 items, each rated on a scale from 0-4 for level of difficulty) Score range: Pain subscale 0-20 WOMAC points; Joint stiffness subscale 0-8 WOMAC points. Physical function subscale 0-68 WOMAC points. Total score 0-96 WOMAC points (96 = worse pain, stiffness and physical function). Subscales are summed for total score | One at 6 week visit, one during 3 month clinic visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation