A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension

Study Overview
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Brief Summary
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The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed. Construct validity will be assessed by the Pearson's correlation coefficient between self-selected community walking speed and the 4-meter walk test. The objective of this multicenter, prospective study is to demonstrate that remote measurement of community walking speed with the Canary canturioTM (CTE) tibial extension is correlated with the fast 4-meter walk test (4mWT).

Detailed Description
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The primary endpoint is community walking speed, calculated as a mean, remotely captured over the 7 days prior to the patient's regularly scheduled office visit: specifically, the correlation (Pearson correlation coefficient) of community walking speed with the 4mWT. The secondary endpoints are as follows: Correlation coefficient between community walking speed and the Timed Up and Go (TUG) Test Completeness of data collection and transmission by the study device Correlation coefficient between community walking speed and the Oxford Knee Score Correlation coefficient between community walking speed and the Knee Injury and Osteoarthritis Outcome Score Jr (KOOS JR)

Official Title
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A Multicenter, Single- Arm Postmarket Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Performance Clinical Outcome Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be 18 years of age or older at the time of surgery Patient is scheduled for or has undergone primary total knee arthroplasty using a Persona Personalized Knee System with Canary Tibial Extension (PIQ) TKA implant according to the appropriate surgical technique and IFU. Patient must be willing and able to complete the protocol required follow-up Patient has participated in the study-related informed consent process Patient has a platform-compatible personal computer located in their dwelling with substantially reliable wireless internet access and a USB port Exclusion Criteria: Simultaneous bilateral TKA Staged bilateral TKA less than 6 months from indexed procedure Patient is a current alcohol or drug abuser Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.) Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program Patient has previous history of infection in the affected joint and/or a local or systemic infection that may affect the prosthetic joint Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions Patient with Neuropathic Arthropathy Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin Patient is undergoing procedures or treatments using ionizing radiation Patient has a known or suspected sensitivity to one or more of the implant materials. Patients with known orthopaedic lower extremity, spinal and/or neurologic conditions that could affect gait

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PIQ Patients<br>Patient is scheduled for or has undergone primary total knee arthroplasty (TKA) using a Persona Personalized Knee System with Canary Tibial Extension (PIQ) TKA implant according to the appropriate surgical technique and IFU. If you decide to take part in this research study, the general procedures include one follow-up visit where you will be asked to complete two performance-based tests that are used to assess your physical function following Total Knee Arthroplasty (TKA). As part of your standard of care, you will receive a Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension. As part of this study, subjects will be asked to perform two performance based tests called the 4 meter walk test and the timed up and go test. Subjects will also be asked to complete a series of patient questionnaires that will assess their post-operative function. | Other: Performance Clinical Outcome Test<br>* Patients will be asked to perform a fast 4-meter walk test (4mWT) and the Timed up and Go (TUG) test in the clinic during their post-operative follow-up visit. Both performance exams will be performed in a controlled environment within the physician's clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 Meter Walk Test | A 4MWT test will be performed in the physician's clinic along a clear pathway of at least 8 in length in a designated area over solid flooring. The 8-m distance will be measured with a starting (0m) and an end point (8m) with additional marks at 2m and 6m to identify the 4m which is the timed portion of the test. A handheld, calibrated stopwatch will be used as the gold standard for measuring walking speed output during the 4 mWT, measuring the time it takes to complete the test. | 4 wks+2 weeks post TKA | 
| Timed Up and Go Test *(TUG) | Patients may use a walking aid if needed. Patients will begin by sitting back in a standard armchair. Investigator will identify a line 3 meters (9.8 feet) away on the floor. When the investigator says go the patient will: stand up from the chair walk to the line on the floor at a comfortable and safe walking speed turn and walk back to the chair at a comfortable and safe walking speed Sit down again A stopwatch will be used to record the time it takes from the initiation of the exam on the word go to the end of the exam when the patient's buttocks touch the seat. | 4 wks+2 weeks post TKA | 
| Community Walking Speed | Average walking speed | 7 days prior to follow-up appoinment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | Patient Reported Outcome on level of Pain | wks+2 weeks post TKA | 
| Oxford Knee Score | Patient Reported Outcome on Clinical Function | wks+2 weeks post TKA | 
| KOOS Jr | Patient Reported Outcome on Clinical Function | 4wks+2 weeks post TKA | 
| Clinical Limping Evaluation | Self Evaluation of Limping | 4wks+2 weeks post TKA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, Canary canturio™te with Canary Health Implanted Reporting Processor, clinical outcomes, 4 meter walk test