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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIQ Patients | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Performance Clinical Outcome Test | Other | 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. |
| 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:
| 4 wks+2 weeks post TKA |
| Community Walking Speed | Average walking speed | 7 days prior to follow-up appoinment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vail Summit Orthopaedics and Neurosurgery | Frisco | Colorado | 80443 | United States | ||
| South Bend Orthopaedics |
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| 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 |
| South Bend |
| Indiana |
| 46635 |
| United States |
| Mississippi Sports Medicine and Orthopaedic Center | Jackson | Mississippi | 39202 | United States |
| Orthopedic NJ | Sparta | New Jersey | 07871 | United States |
| Dr. Ballard | Oregon City | Oregon | 97045 | United States |
| Orthopaedic Surgery and Sports Medicine | San Antonio | Texas | 78209 | United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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